Order of the State Administration for Market Regulation

No. 47

The "Measures for the Administration of Registration and Filing of Medical Devices" were passed at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021, and are now announced. They will come into effect on October 1, 2021.

Director Zhang Gong

August 26, 2021

Management Measures for Registration and Filing of Medical Devices

Chapter 1 General Provisions

Article 1: In order to standardize the registration and filing of medical devices, ensure the safety, effectiveness, and controllable quality of medical devices, this method is formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices".

Article 2: These Measures shall apply to the registration, filing, and supervision and management activities of medical devices within the territory of the People's Republic of China.

Article 3: Medical device registration refers to the activity where the applicant for medical device registration (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with legal procedures and requirements, and the drug regulatory department conducts safety, effectiveness, and quality controllability reviews based on scientific knowledge in accordance with laws and regulations, to decide whether to agree with their application.

Medical device registration refers to the activity of the medical device registrant (hereinafter referred to as the registrant) submitting registration materials to the drug regulatory department in accordance with legal procedures and requirements, and the drug regulatory department archives the submitted registration materials for future reference.

Article 4: The National Drug Administration is responsible for the registration and filing management of medical devices nationwide, responsible for establishing a system and system for medical device registration and filing management, organizing the review and approval of domestic Class III and imported Class II and III medical devices in accordance with the law, the filing of imported Class I medical devices, and related supervision and management work, and providing supervision and guidance for local medical device registration and filing work.

Article 5: The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the National Medical Device Evaluation Center) is responsible for the technical evaluation of medical device clinical trial applications that require clinical trial approval, as well as domestic Class III and imported Class II and Class III medical device product registration applications, change registration applications, and continuation registration applications.

Other professional and technical institutions such as the Medical Device Standards Management Center of the National Drug Administration, the China Food and Drug Control Research Institute, the Food and Drug Audit and Inspection Center of the National Drug Administration (hereinafter referred to as the National Bureau Audit and Inspection Center), the Drug Evaluation Center of the National Drug Administration, the Administrative Matters Acceptance Service and Complaint Reporting Center of the National Drug Administration, and the Information Center of the National Drug Administration, Responsible for the standard management, classification and definition, inspection, verification, monitoring and evaluation, certification and delivery, as well as corresponding information construction and management of medical devices required for the implementation of medical device supervision and management.

Article 6: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the management of the registration of medical devices within their respective administrative regions:

（1） Review and approval of registration of domestic second-class medical devices;

（2） Verification of the quality management system for domestic Class II and Class III medical devices;

（3） Organize medical device clinical trial institutions and supervise and manage clinical trials in accordance with the law;

（4） Supervision and guidance on the filing of Class I medical devices within the jurisdiction of the drug supervision and management department at the municipal level with districts.

Medical device professional technical institutions established or designated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall be responsible for the technical review, inspection, verification, monitoring, and evaluation required for the implementation of medical device supervision and management.

The department responsible for drug supervision and management at the municipal level with districts is responsible for the filing and management of Class I medical device products in China.

Article 7: The registration and filing management of medical devices shall follow the principles of law, science, openness, fairness, and impartiality.

Article 8: The first category of medical devices shall be subject to product filing management. The second and third categories of medical devices are subject to product registration management.

For the filing of Class I medical devices within the territory, the registrant shall submit the filing materials to the department responsible for drug supervision and management at the city level with districts.

The second category of medical devices within the territory shall be reviewed and approved by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government, and a medical device registration certificate shall be issued after approval.

The third category of medical devices within the country shall be reviewed and approved by the National Drug Administration, and a medical device registration certificate shall be issued after approval.

For the registration of imported Class I medical devices, the registrant shall submit the registration materials to the National Drug Administration.

The import of Class II and Class III medical devices shall be reviewed and approved by the National Drug Administration, and a medical device registration certificate shall be issued after approval.

Article 9: Medical device registrants and registrants shall strengthen the quality management of the entire life cycle of medical devices, and shall be responsible for the safety, effectiveness, and quality controllability of medical devices throughout the entire process of development, production, operation, and use in accordance with the law.

Article 10: The National Drug Administration shall give priority to the approval of urgently needed clinical medical devices, implement special approval for innovative medical devices, encourage research and innovation of medical devices, and promote high-quality development of the medical device industry.

Article 11: The National Drug Administration shall establish and improve a system of medical device standards, technical guidance principles, etc. in accordance with the law, standardize the technical evaluation and quality management system verification of medical devices, guide and serve the research and development and registration applications of medical devices.

Article 12: The drug regulatory department shall promptly disclose relevant information on the registration and filing of medical devices in accordance with the law. Applicants may inquire about the approval progress and results, and the public may access the approval results.

Without the consent of the applicant, personnel such as drug regulatory departments, professional technical institutions, and their staff, as well as experts participating in the review, shall not disclose trade secrets, undisclosed information, or confidential business information submitted by the applicant or the filing person, except as otherwise provided by law or involving national security or significant social public interests.

Chapter 2 Basic Requirements

Article 13: The registration and filing of medical devices shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guidance principles to prove that the registered and filed medical devices are safe, effective, and of controllable quality, and ensure that the information throughout the entire process is true, accurate, complete, and traceable.

Article 14: The applicant and registrant shall be an enterprise or research and development institution that can bear corresponding legal responsibilities.

Overseas applicants and registrants shall designate corporate legal persons within China as agents to handle relevant medical device registration and filing matters. The agent shall assist the registrant and registrant in fulfilling their obligations under Article 20, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist overseas registrants and registrants in fulfilling their corresponding legal responsibilities.

Article 15: The applicant and the registrant shall establish a quality management system that is suitable for the product and maintain effective operation.

Article 16: Personnel handling the registration and filing of medical devices shall possess corresponding professional knowledge and be familiar with the laws, regulations, rules, and relevant provisions on registration management of medical device registration and filing.

Article 17: When applying for registration or filing, relevant materials shall be submitted in accordance with the requirements of the National Drug Administration for registration and filing. The applicant and the filing person are responsible for the authenticity of the materials.

Registration and filing materials should be in Chinese. If translated based on foreign language materials, the original text should also be provided. When citing unpublished literature and materials, documents licensed by the data rights holder should be provided.

Article 18: To apply for the registration of imported medical devices and handle the registration of imported medical devices, proof documents from the competent authorities of the country (region) where the applicant or the registrant is registered or the production place is located that allow the medical device to be listed for sale shall be submitted.

If the country (region) where the applicant or registrant is registered or produced does not manage the product as a medical device, the applicant or registrant must provide relevant documents, including proof that the country (region) where the registration or production is located allows the product to be marketed.

Innovative medical devices that have not been listed in the country (region) where the applicant or registrant is registered or produced do not need to submit relevant documents.

Article 19 Medical devices shall comply with applicable mandatory standards. If the product's structural characteristics, intended use, usage methods, etc. are inconsistent with the scope of application of mandatory standards, the applicant and registrant shall provide an explanation of the non application of mandatory standards and provide relevant information.

If there are no mandatory standards, applicants and filers are encouraged to adopt recommended standards.

Article 20: The registration and filing of medical devices shall comply with the relevant requirements of the classification rules and classification catalogs for medical devices.

Article 21: The drug regulatory authorities shall continue to promote the reform of the review and approval system, strengthen scientific research on medical device supervision, establish a medical device registration management technology system led by technical review, supported by verification, inspection, monitoring, and evaluation, optimize the review and approval process, improve the review and approval ability, and improve the quality and efficiency of review and approval.

Article 22: Medical device professional technical institutions shall establish a sound communication and exchange system, clarify the form and content of communication and exchange, and organize communication and exchange with applicants according to work needs.

Article 23 Medical device professional technical institutions shall establish an expert consultation system according to work needs, listen to expert opinions on major issues during the review, verification, inspection, and other processes, and fully leverage the technical support role of experts.

Chapter 3 Medical Device Registration

Section 1 Product Development

Article 24: The development of medical devices shall follow the principles of risk management, consider the existing recognized technological level, ensure that all known and foreseeable risks and unexpected impacts of the product are minimized and acceptable, and ensure that the benefits of the product outweigh the risks in normal use.

Article 25: Engaging in the development and experimental activities of medical device products shall comply with the requirements of relevant laws, regulations, and mandatory standards in China.

Article 26: Applicants and registrants shall prepare product technical requirements for applying for registration or filing medical devices.

The product technical requirements mainly include the functional and safety indicators and testing methods that can be objectively judged for the finished medical device.

Medical devices should meet the technical requirements of registered or registered products.

Article 27: Applicants and registrants shall prepare product manuals and labels for medical devices that apply for registration or are subject to registration.

The product manual and label should comply with the requirements of Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant regulations.

Article 28: In the development of medical devices, non clinical research on medical devices shall be conducted based on the scope of product application and technical characteristics.

Non clinical studies include research on product chemistry and physical properties, electrical safety, radiation safety, software, biological characteristics, safety of biological materials, disinfection and sterilization processes, animal experiments, stability studies, etc.

When applying for registration or filing, non clinical evidence generated during research and development activities should be submitted, including a summary of non clinical research reports, research plans, and research reports.

Article 29: The functional and safety indicators and methods determined during the non clinical research process of medical devices shall be suitable for the expected use conditions and purposes of the product, and the research samples shall be representative and typical. If necessary, methodological validation and statistical analysis should be conducted.

Article 30: When applying for registration or filing, an inspection shall be conducted in accordance with the technical requirements of the product and an inspection report shall be submitted. Only those who pass the inspection can conduct clinical trials or apply for registration or filing.

Article 31: Products used for inspection shall represent the safety and effectiveness of the products applied for registration or filed, and their production shall comply with the relevant requirements of the quality management standards for medical device production.

Article 32: The medical device product inspection report submitted for registration or filing may be the self inspection report of the applicant or the registrant, or the inspection report issued by a qualified medical device inspection institution entrusted.

Section 2 Clinical Evaluation

Article 33 Except for the circumstances specified in Article 34 of these Measures, the registration and filing of medical device products shall undergo clinical evaluation.

Clinical evaluation of medical devices refers to the activity of analyzing and evaluating clinical data using scientific and reasonable methods to confirm the safety and effectiveness of medical devices within their scope of application.

To apply for medical device registration, clinical evaluation materials should be submitted.

Article 34: Under any of the following circumstances, clinical evaluation may be exempted:

（1） The working mechanism is clear, the design is standardized, the production process is mature, and the same type of medical device has been clinically applied for many years without serious adverse event records, without changing its conventional use;

（2） Other non clinical evaluations can demonstrate the safety and effectiveness of the medical device.

Those who are exempt from clinical evaluation may be exempted from submitting clinical evaluation materials.

The list of medical devices exempt from clinical evaluation shall be formulated, adjusted, and published by the National Drug Administration.

Article 35: Clinical evaluation of medical devices may be conducted based on product characteristics, clinical risks, existing clinical data, etc., by conducting clinical trials, or by analyzing and evaluating clinical literature and data of the same variety of medical devices, to prove the safety and effectiveness of medical devices.

According to the regulations of the National Drug Administration, when conducting clinical evaluation of medical devices, if the existing clinical literature and data are insufficient to confirm the safety and effectiveness of the product, clinical trials should be conducted.

The National Drug Administration has formulated guidelines for clinical evaluation of medical devices, clarifying the requirements for clinical evaluation through clinical literature and data of the same variety of medical devices, the situations where clinical trials need to be conducted, and the requirements for writing clinical evaluation reports.

Article 36: If clinical evaluation is conducted through clinical literature and data of the same type of medical device, the clinical evaluation data shall include a comparison between the registered product and the same type of medical device, analysis and evaluation of clinical data of the same type of medical device, scientific evidence and evaluation conclusions when there are differences between the registered product and the same type of product.

Clinical evaluation conducted through clinical trials includes clinical trial protocols, ethical committee opinions, informed consent forms, clinical trial reports, etc.

Article 37: Clinical trials of medical devices shall be conducted in accordance with the requirements of the quality management standards for clinical trials of medical devices, in medical device clinical trial institutions that meet the corresponding conditions and are registered in accordance with regulations. Before the start of a clinical trial, the clinical trial applicant shall file a clinical trial with the drug regulatory department of the province, autonomous region, or municipality directly under the central government where it is located. The production of clinical trial medical devices should comply with the relevant requirements of the quality management standards for medical device production.

Article 38: Clinical trials of Class III medical devices that pose a high risk to the human body shall be approved by the National Drug Administration.

Clinical trial approval refers to the process in which the National Drug Administration, based on the applicant's application, conducts a comprehensive analysis of the risk level, clinical trial plan, clinical benefit and risk comparison analysis report of the medical device intended for clinical trial, in order to decide whether to agree to carry out clinical trial.

The list of Class III medical devices that require clinical trial approval shall be formulated, adjusted, and published by the National Drug Administration. Clinical trials of Class III medical devices that require clinical trial approval should be conducted in a qualified Class III Grade A medical institution.

Article 39: For medical device clinical trial approval, the applicant shall submit application materials such as review materials, research materials, clinical materials, product manuals, and label samples in accordance with relevant requirements.

Article 40: The Device Evaluation Center of the National Bureau shall evaluate the accepted clinical trial applications. A decision on whether to agree to a clinical trial application shall be made within 60 days from the date of acceptance, and the applicant shall be notified through the website of the National Bureau of Device Evaluation Center. If no notice is given within the time limit, it shall be deemed as consent.

Article 41: If the applicant needs to supplement and correct the information during the evaluation process, the National Bureau of Equipment Evaluation Center shall inform the applicant of all the content that needs to be supplemented and corrected at once. The applicant shall provide supplementary information in accordance with the requirements of the correction notice within one year after receiving it. After receiving the supplementary materials, the Equipment Evaluation Center of the National Bureau shall complete the technical review within the prescribed time limit.

If the applicant has objections to the content of the correction notice, they can submit written opinions to the National Bureau of Device Evaluation Center, explain the reasons, and provide corresponding technical support materials.

If the applicant fails to submit supplementary materials within the prescribed time limit, the technical review shall be terminated and a decision shall be made not to approve.

Article 42: For serious adverse events related to clinical trial medical devices or other serious safety risk information that occur during the clinical trial of medical devices, clinical trial applicants shall, in accordance with relevant requirements, report to the drug regulatory authorities of the province, autonomous region, or municipality where the clinical trial institution is located and take risk control measures. If no risk control measures have been taken, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall order the applicants to take corresponding risk control measures in accordance with the law.

Article 43: In the clinical trial of medical devices, if there are serious adverse events related to large-scale clinical trials of medical devices or other major safety issues, the applicant shall suspend or terminate the clinical trial of medical devices and report to the drug regulatory authorities of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located. If not suspended or terminated, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall order the applicants to take corresponding risk control measures in accordance with the law.

Article 44: If a clinical trial that has been approved to be conducted falls under any of the following circumstances, the State Drug Administration may order the applicant to terminate the clinical trial of the medical device that has been conducted:

（1） False clinical trial application materials;

（2） The latest research has confirmed that there are ethical and scientific issues with the original approved clinical trial;

（3） Other situations that should be terminated.

Article 45: Clinical trials of medical devices shall be carried out within 3 years after approval; If no subject signs the informed consent form within 3 years from the date of approval for the clinical trial application of a medical device, the clinical trial license of the medical device shall automatically become invalid. If clinical trials are still needed, a new application should be made.

Article 46: Medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatment methods may benefit patients through medical observation. After ethical review and informed consent, they can be used free of charge for other patients with the same condition in institutions conducting clinical trials of medical devices. Their safety data can be used for medical device registration applications.

Section 3 Registration System Verification

Article 47: Applicants shall submit relevant materials related to the quality management system related to product development and production when applying for registration. If the drug regulatory department that accepts the registration application deems it necessary to verify the quality management system during the product technical review, it shall organize quality management system verification and may access the original materials as needed.

Article 48: The quality management system verification of Class III medical devices within the territory of China shall be carried out by the Device Evaluation Center of the National Bureau, which shall notify the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the applicant is located.

The verification of the quality management system for Class II medical devices in China shall be organized and carried out by the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the applicant is located.

Article 49: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall conduct quality management system inspections in accordance with the requirements of the quality management standards for medical device production, with a focus on verifying whether the applicant has established a quality management system that is suitable for the product in accordance with the requirements of the quality management standards for medical device production, as well as the design and development, production management, quality control, and other related contents related to product development and production.

During the verification process, the authenticity of the inspection products and clinical trial products should be verified simultaneously, with a focus on reviewing relevant records of the design and development process, as well as the production process of the inspection products and clinical trial products.

When submitting a self inspection report, a key verification should be conducted on the inspection capabilities and results of the applicant, registrant, or entrusted institution during the development process.

Article 50: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government may conduct quality management system verification through data review or on-site inspection. Based on the specific situation of the applicant, the supervision and inspection situation, and the comparison between the production conditions and processes of the products registered in this application and those that have been verified in the past, determine whether to conduct on-site inspections and the inspection content to avoid duplicate inspections.

Article 51: When the National Bureau's Equipment Evaluation Center conducts technical evaluations of imported Class II and Class III medical devices, if it deems it necessary to conduct quality management system inspections, it shall notify the National Bureau's Audit and Inspection Center to conduct inspections according to relevant requirements.

Section 4 Product Registration

Article 52: After completing the safety and effectiveness research supporting the registration of medical devices and preparing for quality management system verification, the applicant shall submit a medical device registration application and submit the following registration application materials to the drug regulatory department through online registration applications and other channels in accordance with relevant requirements:

（1） Product risk analysis data;

（2） Product technical requirements;

（3） Product inspection report;

（4） Clinical evaluation data;

（5） Product manual and label sample;

（6） Quality management system documents related to product development and production;

（7） Other materials required to prove the safety and effectiveness of the product.

Article 53: After receiving the application, the drug regulatory department shall review the application materials and handle them according to the following situations:

（1） If the application matters fall within the scope of the authority of this administrative agency, and the application materials are complete and meet the requirements for formal review, they shall be accepted;

（2） If there are errors in the application materials that can be corrected on the spot, the applicant should be allowed to correct them on the spot;

（3） If the application materials are incomplete or do not comply with the legal form, the applicant shall be notified of all the necessary corrections on the spot or within 5 days. If the applicant fails to inform within the time limit, it shall be deemed accepted from the date of receiving the application materials;

（4） If the application matters do not fall within the scope of the administrative authority in accordance with the law, a decision on rejection shall be made immediately and the applicant shall be notified to apply to the relevant administrative authority.

If the drug regulatory department accepts or refuses to accept the application for medical device registration, it shall issue a notice of acceptance or refusal stamped with the special seal of the administrative authority and dated.

After the acceptance of the medical device registration application, if the applicant needs to pay fees, the applicant shall pay the fees in accordance with the regulations. If the applicant fails to pay the fees within the prescribed time limit, it shall be deemed that the applicant has voluntarily withdrawn the application, and the drug regulatory department shall terminate its registration process.

Article 54: In the process of technical evaluation, if the applicant needs to supplement and correct the information, the technical evaluation institution shall inform the applicant of all the content that needs to be supplemented and corrected at once. The applicant shall provide supplementary information in accordance with the requirements of the correction notice within one year after receiving it; After receiving the supplementary information, the technical review institution shall complete the technical review within the prescribed time limit.

If the applicant has objections to the content of the correction notice, they may submit written opinions to the corresponding technical evaluation institution, explain the reasons, and provide corresponding technical support materials.

If the applicant fails to submit supplementary materials within the prescribed time limit, the technical evaluation shall be terminated, and the drug regulatory department shall make a decision not to register.

Article 55: For a registered application that has been accepted, the applicant may, before the administrative licensing decision is made, apply to the drug regulatory department that has accepted the application to withdraw the registration application and relevant materials, and explain the reasons. If the applicant agrees to withdraw the application, the drug regulatory department shall terminate its registration process.

If any illegal behavior such as concealing the true situation or providing false information is found during the review, verification, and approval process, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the medical device registration application.

Article 56: If there is evidence indicating that the registration application materials that have been accepted may be false, the drug regulatory department may suspend the review and approval. After verification, continue the review or make a decision not to register based on the verification conclusion.

Article 57: During the evaluation period of medical device registration applications, if a review conclusion is to be made that fails, the technical evaluation institution shall inform the applicant of the reasons for the failure. The applicant may raise objections to the technical evaluation institution within 15 days, and the objection content is limited to the original application items and original application materials. The technical evaluation institution shall conduct a comprehensive evaluation based on the applicant's objections and provide feedback to the applicant. The time for handling objections is not included in the review deadline.

Article 58: The drug regulatory department that accepts registration applications shall make a decision on whether to approve or not after the technical review is completed. For products that meet the requirements of safety, effectiveness, and controllable quality, registration is granted and a medical device registration certificate is issued. The approved product technical requirements are sent to the applicant in the form of an attachment. For those who refuse to register, they shall provide a written explanation and inform the applicant of their right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

The validity period of the medical device registration certificate is 5 years.

Article 59: For the registration application that has been accepted, if one of the following situations occurs, the drug regulatory department shall make a decision not to register and inform the applicant:

（1） The applicant's research on the safety, effectiveness, and quality controllability of medical devices intended for sale on the market and its results cannot prove the product's safety, effectiveness, and quality controllability;

（2） The quality management system verification fails, and the applicant refuses to accept the on-site inspection of the quality management system;

（3） The registration application materials are false;

（4） The content of the registration application materials is chaotic and contradictory, and the content of the registration application materials is clearly inconsistent with the application items, which cannot prove that the product is safe, effective, and controllable in quality;

（5） Other situations where registration is not allowed.

Article 60: For matters that require a hearing in the implementation of administrative licensing according to laws, regulations, and rules, or other major administrative licensing matters that involve public interests that the drug regulatory department deems necessary, the drug regulatory department shall make a public announcement and hold a hearing. If the application for medical device registration directly involves a significant interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties of the right to request a hearing before making an administrative licensing decision.

Article 61: For medical devices used for the treatment of rare diseases, serious life-threatening diseases without effective treatment methods, and urgently needed in response to public health events, the drug regulatory department may make a conditional approval decision, and specify in the medical device registration certificate the validity period, research work that needs to be continued after listing, and completion time limit.

Article 62: For conditionally approved medical devices, the registrant shall collect relevant data on benefits and risks after the medical device is launched, continuously monitor and evaluate the benefits and risks of the product, take effective measures to actively control risks, and complete the research and submit relevant materials as required within the specified period.

Article 63: For medical devices that have been conditionally approved, if the registrant fails to complete the research as required or cannot prove that the benefits outweigh the risks, the registrant shall promptly apply for the cancellation of the medical device registration certificate. The drug regulatory department may cancel the medical device registration certificate in accordance with the law.

Article 64 For newly developed medical devices that have not been included in the classification catalog, the applicant may directly apply for the registration of Class III medical device products, or determine the product category based on the classification rules and apply to the National Drug Administration for category confirmation before applying for product registration or filing.

For those who directly apply for the registration of Class III medical devices, the National Drug Administration shall determine the category based on the degree of risk. If domestic medical devices are classified as Class II or Class I, the applicant shall be notified to apply for registration or filing with the corresponding drug regulatory department.

Article 65: If the management category of registered medical devices is adjusted from high category to low category, the medical device registration certificate shall continue to be valid during its validity period. If the validity period needs to be extended, an application for extension of registration or filing shall be made to the corresponding drug regulatory department according to the adjusted category 6 months before the expiration of the medical device registration certificate.

If the management category of medical devices is adjusted from low to high, the registrant shall apply for registration with the corresponding drug regulatory department according to the changed category. The National Drug Administration shall specify the time limit for completing the adjustment in the notice of management category adjustment.

Article 66: If the medical device registration certificate and its attachments are lost or damaged, the registrant shall apply to the original issuing authority for reissuing them, and the original issuing authority shall verify and reissue them.

Article 67: If a patent dispute arises during the examination process of a registration application or after approval, it shall be handled in accordance with the provisions of relevant laws and regulations.

Chapter 4 Special Registration Procedures

Section 1 Innovative Product Registration Procedure

Article 68 For medical devices that meet the following requirements, applicants may apply for the application of innovative product registration procedures:

（1） The applicant, through its leading technological innovation activities, legally owns the core technology invention patent right of the product in China, or obtains the invention patent right or its use right in China through transfer in accordance with the law, and the time for applying for the applicable innovative product registration procedure is within 5 years from the date of patent authorization announcement; Or the application for patent for core technology invention has been disclosed by the patent administration department under the State Council, and the patent search and consultation center of the China National Intellectual Property Administration has issued a search report, indicating that the core technology solution of the product has novelty and creativity;

（2） The applicant has completed preliminary research on the product and has a basic finalized product. The research process is real and controlled, and the research data is complete and traceable;

（3） The main working principle or mechanism of the product is the first in China, and the performance or safety of the product has been fundamentally improved compared to similar products. The technology is at the international leading level and has significant clinical application value.

Article 69: If an applicant applies for the registration procedure of innovative products, they shall submit an application for the examination of innovative medical devices to the National Drug Administration after the product is basically finalized. The National Drug Administration organizes experts for review, and those that meet the requirements will be included in the innovative product registration process.

Article 70: For medical device registration applications that are subject to innovative product registration procedures, the National Drug Administration and the institutions responsible for relevant technical work shall designate dedicated personnel to be responsible for timely communication and provide guidance according to their respective responsibilities.

For medical devices included in the registration process of innovative products, the National Bureau of Medical Device Evaluation Center can communicate and exchange with applicants on major technical issues, major safety issues, clinical trial plans, and summary and evaluation of phased clinical trial results in product development before and during the registration application acceptance process.

Article 71: If the applicant voluntarily requests the termination of medical devices included in the innovative product registration procedure or the State Drug Administration finds that they no longer meet the requirements of the innovative product registration procedure, the State Drug Administration shall terminate the innovative product registration procedure for the relevant products and notify the applicant.

Article 72: For medical devices included in the innovative product registration procedure, if the applicant fails to submit a registration application within the prescribed period, the innovative product registration procedure shall no longer apply.

Section 2 Priority Registration Procedure

Article 73: Medical devices that meet one of the following conditions may apply for priority registration procedures:

（1） Diagnosis or treatment of rare diseases or malignant tumors with obvious clinical advantages, diagnosis or treatment of elderly specific and multiple diseases without effective diagnosis or treatment methods, dedicated to children with obvious clinical advantages, or urgently needed medical devices with no approved registration of the same product in China;

（2） Medical devices included in national major scientific and technological projects or national key research and development plans;

（3） Other medical devices that can be subject to priority registration procedures as stipulated by the National Drug Administration.

Article 74: When applying for the priority registration procedure, the applicant shall submit an application for the priority registration procedure to the National Drug Administration when submitting the application for medical device registration. If the situation falls under the first item of Article 73, the State Drug Administration shall organize experts to conduct an audit. If it meets the requirements, it shall be included in the priority registration procedure; If it falls under the second item of Article 73, it shall be reviewed by the Equipment Evaluation Center of the National Bureau, and if it meets the requirements, it shall be included in the priority registration procedure; In the case of the third item of Article 73, the State Drug Administration shall widely listen to opinions and organize expert argumentation to determine whether to include it in the priority registration procedure.

Article 75: For medical device registration applications that are included in the priority registration procedure, the National Drug Administration shall give priority to review and approval, and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall give priority to arranging the verification of the quality management system for medical device registration.

During the technical evaluation process of medical device products included in the priority registration procedure, the National Bureau of Medical Device Evaluation Center shall actively communicate and exchange with applicants in accordance with relevant regulations, and may arrange special exchanges if necessary.

Section 3 Emergency Registration Procedure

Article 76: The National Drug Administration may, in accordance with the law, implement emergency registration for medical devices that are required for emergency response to public health emergencies and have not yet been marketed in China, or for medical devices that have already been marketed in China but cannot meet the emergency response requirements for public health emergencies.

Article 77: When applying for the application of emergency registration procedures, the applicant shall submit an emergency registration application to the State Drug Administration. Those that meet the conditions will be included in the emergency registration procedure.

Article 78: For medical device registration applications that implement emergency registration, the National Drug Administration shall handle them in accordance with the requirements of unified command, early intervention, on-demand review, and scientific approval, and carry out medical device product inspection, system verification, technical evaluation, and other work in parallel.

Chapter 5 Change of Registration and Continuation of Registration

Section 1 Change of Registration

Article 79: The registrant shall actively conduct post market research on medical devices, further confirm the safety, effectiveness, and quality controllability of medical devices, and strengthen the continuous management of listed medical devices.

If there are substantial changes in the design, raw materials, production process, scope of application, usage methods, etc. of registered Class II and Class III medical device products that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for registration change procedures; If other changes occur, they shall be filed with the original registration department within 30 days from the date of the change.

The product name, model, specifications, structure and composition, scope of application, product technical requirements, and production address of imported medical devices specified in the registration certificate belong to the matters that require registration changes as stipulated in the preceding paragraph. The name and address of the registrant, the name and address of the agent, and other matters that need to be filed as stipulated in the preceding paragraph. If the production address of domestic medical devices is changed, the registrant shall apply for registration after handling the corresponding production license change.

If other changes occur, the registrant shall carry out relevant work in accordance with the requirements of the quality management system and report to the drug regulatory department in accordance with regulations.

Article 80: For changes in registration applications, the technical evaluation institution shall focus on the evaluation of the changed parts, and form evaluation opinions on whether the products after the changes are safe, effective, and controllable in quality.

When conducting a technical review of a change of registration application, if it is deemed necessary to verify the quality management system, the drug regulatory department shall organize a quality management system verification.

Article 81: The registration documents for changes in medical devices shall be used in conjunction with the original medical device registration certificate, and the expiration date shall be the same as the original medical device registration certificate.

Section 2 Continuation of Registration

Article 82: If the validity period of the medical device registration certificate expires and the registration needs to be extended, the registrant shall apply for the extension of registration to the original registration department 6 months before the expiration of the medical device registration certificate, and submit application materials in accordance with relevant requirements.

Except for the circumstances specified in Article 83 of these Measures, the drug regulatory department that receives the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If a decision is not made within the prescribed time limit, it shall be deemed that the extension is granted.

Article 83: In any of the following circumstances, the registration shall not be renewed:

（1） Failure to submit an application for renewal of registration within the prescribed time limit;

（2） The new mandatory standards for medical devices have been released and implemented, and medical devices applying for registration extension cannot meet the new requirements;

（3） Medical devices approved with conditions have not completed the items specified in the medical device registration certificate within the specified period.

Article 84: If the approval time for continuing registration is within the validity period of the original registration certificate, the starting date of the validity period of the continued registration certificate shall be the day after the expiration date of the original registration certificate; If the approval time is not within the validity period of the original registration certificate, the starting date of the validity period of the continued registration certificate shall be the date of approval for the continued registration.

Article 85: If there are no provisions in this chapter regarding the acceptance and approval procedures for medical device registration change and extension applications, the relevant provisions in Chapter 3 of these Measures shall apply.

Chapter 6 Medical Device Filing

Article 86 Before the production of Class I medical devices, product registration shall be conducted.

Article 87: For the filing of medical devices, the registrant shall submit the filing materials to the drug regulatory department in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices, and obtain the filing number.

Article 88: If there is a change in the content and technical requirements of the registered medical devices in the registration information table, the registrant shall change the registration to the original registration department and submit an explanation of the change and relevant documents. The drug regulatory department shall record the changes in the record keeping information.

Article 89: If the registered medical device management category is adjusted to Class II or Class III medical devices, registration shall be applied for in accordance with the provisions of these Measures.

Chapter 7 Work Time Limit

Article 90 The time limit specified in these Measures is the maximum time for the acceptance, technical evaluation, verification, approval, and other work of medical device registration. The working time limit related to the special registration procedure shall be executed in accordance with the relevant provisions of the special registration procedure.

Professional technical institutions such as the National Bureau's Equipment Evaluation Center shall clearly define their own work procedures and time limits, and make them public to the society.

Article 91: After receiving the application for medical device registration and clinical trial, the drug regulatory department shall, within 3 days from the date of acceptance, transfer the application materials to the technical evaluation institution. The acceptance requirements for clinical trial applications shall apply to Article 53 of these Measures.

Article 92: The time limit for technical evaluation of medical device registration shall be implemented in accordance with the following provisions:

（1） The technical review time limit for clinical trial applications of medical devices is 60 days, and the technical review time limit for corrected application materials is 40 days;

（2） The technical review time limit for Class II medical device registration applications, change registration applications, and extension registration applications is 60 days, and the technical review time limit for application materials after correction is 60 days;

（3） The technical review time limit for the registration application, change registration application, and extension registration application of the third type of medical device is 90 days, and the technical review time limit for the corrected application materials is 60 days.

Article 93: The verification time limit for the quality management system of Class III medical devices in China shall be implemented in accordance with the following provisions:

（1） The National Medical Device Evaluation Center shall notify the relevant drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government to initiate verification within 10 days after the acceptance of the medical device registration application;

（2） The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall, in principle, complete the inspection within 30 days after receiving the inspection notice, and provide feedback on the inspection situation, results, and other relevant materials to the National Bureau of Device Evaluation Center.

Article 94: The drug regulatory department that accepts registration applications shall make a decision within 20 days from the date of receiving the evaluation opinions.

Article 95: The drug regulatory department shall issue and deliver relevant administrative license documents within 10 days from the date of making the decision on the registration and approval of medical devices.

Article 96: If it is necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification, the extension time limit shall not exceed half of the original time limit. After approval by the head of relevant technical institutions such as medical device technical review and verification, the technical institution that extended the time limit shall notify the applicant in writing and notify other relevant technical institutions.

Article 97: The original issuing authority shall reissue the medical device registration certificate within 20 days from the date of receiving the application.

Article 98: The following time shall not be included in the relevant work time limit:

（1） The time taken by the applicant for supplementary information, rectification after verification, etc;

（2） Delayed verification due to the applicant's reasons;

（3） The time required for external expert consultation, expert consultation meetings, and joint evaluation with drug review agencies for pharmaceutical and mechanical combination products;

（4） If the review and approval process is suspended according to regulations, the time occupied during the suspension of the review and approval process;

（5） The time taken for quality management system verification.

Article 99: The time limit specified in these Measures shall be calculated based on working days.

Chapter 8 Supervision and Management

Article 100: The drug regulatory department shall strengthen the supervision and inspection of the development activities of medical devices. If necessary, extended inspections may be conducted on units and individuals providing products or services for the development of medical devices. Relevant units and individuals shall cooperate, provide relevant documents and materials, and shall not refuse, conceal, or obstruct.

Article 101: The National Drug Administration shall establish and implement a unique identification system for medical devices step by step. Applicants and registrants shall submit information related to the unique identification in accordance with relevant regulations to ensure the authenticity, accuracy, and traceability of the data.

Article 102: The State Drug Administration shall promptly report the information of the agent to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the agent is located. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall carry out daily supervision and management of agent organizations within their respective administrative regions.

Article 103: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall organize post registration supervision and inspection of clinical trial institutions that have already been registered within their respective administrative regions based on the registration status of medical device clinical trial institutions. For newly registered medical device clinical trial institutions, supervision and inspection should be carried out within 60 days after registration.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall organize daily supervision and inspection of the compliance of medical device clinical trial institutions with the quality management standards for medical device clinical trials within their respective administrative regions, and supervise their continuous compliance with the prescribed requirements. The National Drug Administration shall supervise and inspect clinical trial institutions for medical devices as needed.

Article 104 If the drug regulatory department deems it necessary, it may conduct on-site inspections on the authenticity, accuracy, completeness, standardization, and traceability of clinical trials.

Article 105: If the drug regulatory department responsible for the registration of Class I medical device products discovers that the registration materials are not standardized during the post registration supervision, it shall order the registrant to make corrections within a specified period of time.

Article 106: If the drug regulatory department fails to timely discover systemic or regional risks in the registration management of medical devices within its administrative region, or fails to timely eliminate systemic or regional hidden dangers in the registration management of medical devices within its administrative region, the superior drug regulatory department may hold interviews with the main responsible persons of the subordinate drug regulatory department.

Chapter 9 Legal Liability

Article 107: Those who violate the provisions of Article 79 of these Measures and fail to file changes as required shall be ordered to make corrections within a specified time limit; Those who fail to make corrections within the time limit shall be fined not less than 10000 yuan but not more than 30000 yuan.

Article 108: Those who fail to comply with the quality management standards for clinical trials of medical devices shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices.

Article 109: If a medical device technical evaluation institution fails to fulfill its responsibilities in accordance with the provisions of these Measures, resulting in significant errors in the evaluation work, the department responsible for drug supervision and management shall order it to make corrections, circulate a notice of criticism, and give a warning; If serious consequences are caused, the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be punished in accordance with the law.

Article 110: Personnel of the department responsible for drug supervision and management who violate regulations, abuse their power, neglect their duties, or engage in favoritism and fraud shall be punished in accordance with the law.

Chapter 10 Supplementary Provisions

Article 111: In principle, the registration or filing units of medical devices shall be divided based on the technical principles, structural composition, performance indicators, and scope of application of the product.

Article 112: Medical devices approved for registration refer to medical devices that are consistent with the limited content of the medical device registration certificate and its attachments and are produced within the validity period of the medical device registration certificate.

Article 113: If the combined components specified in the "Structure and Composition" column of the medical device registration certificate are used for the purpose of replacing consumables, after-sales service, maintenance, etc., and are used for the original registered product, they may be sold separately.

Article 114: Applicants may obtain authorization from the owner of the medical device main document to refer to the registered medical device main document when applying for medical device product registration, change registration, and clinical trial approval. The relevant work procedures for the registration of medical device master documents shall be separately stipulated.

Article 115: The format of the medical device registration certificate shall be uniformly formulated by the State Drug Administration.

The arrangement of registration certificate numbers is as follows:

× 1 mechanical note × two ×××× three × four ×× five ×××× 6. Among them:

× 1 is the abbreviation for the location of the registration and approval department:

Domestic Class III medical devices, imported Class II and Class III medical devices are referred to as "national";

The second category of medical devices within the territory of China is abbreviated as the province, autonomous region, or municipality where the registration and approval department is located;

× 2 is the registration form:

The word 'quasi' applies to domestic medical devices;

The word 'Jin' applies to imported medical devices;

The word 'Xu' is applicable to medical devices in Hong Kong, Macau, and Taiwan;

×××× 3 is the year of initial registration;

× 4 is the product management category;

×× 5 is the product classification code;

×××× 6 is the first registration serial number.

Continuing registration, ×××× 3 and ×××× The number 6 remains unchanged. If the product management category is adjusted, it should be renumbered.

Article 116 The arrangement of the filing numbers for Class I medical devices is as follows:

× 1 Equipment ×××× two ×××× 3. Among them:

× 1 is the abbreviation for the location of the filing department:

The first category of imported medical devices is referred to as "national";

The first category of medical devices in China is the abbreviation of the province, autonomous region, or municipality where the filing department is located, plus the abbreviation of the city level administrative region where the registration department is located (in the absence of a corresponding city level administrative region with districts, only the abbreviation of the province, autonomous region, or municipality directly under the central government);

×××× 2 is the year of filing;

×××× 3 is the registration serial number.

Article 117 The electronic documents of the medical device registration certificate and change registration documents produced by the drug regulatory department shall have the same legal effect as the paper documents.

Article 118: According to work needs, the National Drug Administration may entrust drug regulatory departments, technical institutions, and social organizations of provinces, autonomous regions, and municipalities directly under the central government to undertake specific work in accordance with the law.

Article 119: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government may formulate special registration procedures for Class II medical devices within their respective administrative regions in accordance with the provisions of Chapter 4 of these Measures, and report them to the National Drug Administration for record keeping.

Article 120 The registration fee items and fee standards for medical device products shall be implemented in accordance with the relevant regulations of the finance and pricing authorities of the State Council.

Article 121: The registration and filing of in vitro diagnostic reagents in accordance with the management of medical devices shall be governed by the "Management Measures for Registration and Filing of in vitro diagnostic reagents".

Article 122: The relevant regulations for the supervision and management of customized medical devices shall be separately formulated by the National Drug Administration.

The relevant regulations on the registration and management of pharmaceutical and mechanical combination products shall be separately formulated by the National Drug Administration.

The relevant regulations for the emergency use of medical devices shall be formulated separately by the State Administration for Drug Administration in conjunction with relevant departments.

Article 123 The registration and filing of medical devices in Hong Kong, Macau, and Taiwan shall be handled with reference to imported medical devices.

Article 124: These measures shall come into effect from October 1, 2021. On July 30, 2014, the "Medical Device Registration Management Measures" promulgated by Order No. 4 of the former State Food and Drug Administration shall be abolished simultaneously.