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Administrative Measures for Registration and Recordation of Medical Devices and In Vitro Diagnostic

Issuing time:2021-09-06 09:57

Order of the State Administration for Market Regulation

   No. 47

   The "Administrative Measures for the Registration and Filing of Medical Devices" have been adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021. They are hereby promulgated and shall come into force on October 1, 2021.

   Director Zhang Gong

   August 26, 2021

   Medical Device Registration and Filing Management Measures

   Chapter 1 General Provisions

   Article 1 In order to regulate the registration and filing of medical devices, and to ensure the safety, effectiveness and quality of medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

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

Article 3 Medical device registration means that the applicant for medical device registration (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with statutory procedures and requirements. The quality controllability and other reviews are used to determine whether to approve the activities they have applied for.

  Medical device filing refers to the activity of the medical device filing person (hereinafter referred to as the filing person) submitting filing materials to the drug regulatory authority in accordance with legal procedures and requirements, and the drug regulatory agency filing the submitted filing materials for review.

Article 4 The National Medical Products Administration is in charge of the national medical device registration and filing management, is responsible for establishing medical device registration and filing management work systems and systems, and organizing the review of domestic third-class and imported second- and third-class medical devices in accordance with the law Approval, filing of imported first-class medical devices and related supervision and management, and supervising and guiding the registration and filing of local medical devices.

Article 5 The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the National Bureau of Medical Device Evaluation Center) is responsible for the clinical trial applications of medical devices that require clinical trial approval, as well as the domestic third category and imported second and third categories Technical review work for medical device product registration applications, modification registration applications, and renewal registration applications.

Medical Device Standards Management Center of the State Drug Administration, China Food and Drug Administration, Food and Drug Inspection and Inspection Center of the State Drug Administration (hereinafter referred to as the National Bureau of Inspection and Inspection Center), the Drug Evaluation Center of the State Drug Administration, and the National Drug Administration Administrative Affairs Acceptance Service and Complaint Reporting Center, National Medical Products Administration Information Center and other professional technical institutions, according to their responsibilities, undertake the medical device standard management, classification and definition, inspection, verification, monitoring and evaluation required for the implementation of medical device supervision and management , Certificate preparation and service, and corresponding informatization construction and management.

  Article 6 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the following medical device registration related management work within their administrative regions:

   (1) Domestic Class II medical device registration review and approval;

   (2) Domestic Class II and Class III medical device quality management system verification;

  (3) Organizing medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law;

   (4) Supervision and guidance on the filing of Class I medical devices within the territory of the districted city-level department responsible for drug supervision and management.

  Professional medical device technical institutions set up or designated by the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government to undertake the technical review, inspection, verification, monitoring and evaluation required for the implementation of medical device supervision and management.

  The department in charge of drug supervision and management at the municipal level with districts is responsible for the registration and management of domestic first-class medical device products.

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

   Article 8 First-class medical devices are subject to product filing management. The second and third categories of medical devices are subject to product registration management.

   Domestic first-class medical device filing, the filing person shall submit the filing materials to the districted city-level department responsible for drug supervision and management.

   The second category of domestic medical devices shall be reviewed by the drug regulatory authority of provinces, autonomous regions, and municipalities directly under the Central Government, and a medical device registration certificate shall be issued after approval.

   The domestic Class III medical devices are reviewed by the State Drug Administration, and a medical device registration certificate will be issued after approval.

  Imported Class I medical devices are filed, and the filer submits the filed materials to the State Drug Administration.

  Imported Class II and Class III medical devices are reviewed by the State Drug Administration, and a medical device registration certificate will be issued after approval.

   Article 9 Medical device registrants and recorders 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 in the entire process of development, production, operation and use.

  Article 10 The National Medical Products Administration shall give priority to clinical examination and approval of medical devices in urgent need, special examination and approval of innovative medical devices, encourage research and innovation of medical devices, and promote the high-quality development of the medical device industry.

   Article 11 The National Medical Products Administration shall establish and improve medical device standards, technical guidelines and other systems in accordance with the law, regulate medical device technical review and quality management system verification, and guide and serve medical device R&D and registration applications.

   Article 12 The drug supervision and administration department shall promptly disclose medical device registration and filing related information in accordance with the law. Applicants can inquire about the progress and results of the examination and approval, and the public can consult the results of the examination and approval.

Without the consent of the applicant, the drug regulatory authority, professional technical institutions and their staff, experts participating in the review and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or the filing party, as otherwise provided by law or Except those involving national security and major 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 guidelines to prove that the registered and filing medical devices are safe, effective, and of acceptable quality. To ensure that the information in the whole process is true, accurate, complete and traceable.

  Article 14 The applicant and filing person shall be an enterprise or research institution that can bear corresponding legal responsibilities.

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

   Article 15 The applicant and the filing party shall establish a quality management system suitable for the product and maintain effective operation.

  Article 16 Personnel handling medical device registration and filing matters shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and related regulations of registration management of medical device registration and filing management.

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

   The registration and filing materials should be in Chinese. If the translation is based on foreign language materials, the original text shall be provided at the same time. When citing unpublished documents and materials, documents permitted to be used by the owner of the materials shall be provided.

  Article 18 To apply for the registration of imported medical devices, and to file for imported medical devices, the applicant, the filing person, or the competent authority of the country (region) where the place of production is located shall be submitted with a certification document that permits the medical device to be marketed.

If the applicant, the place of registration or the country (region) where the place of production is located does not manage the product as a medical device, the applicant and the place of record must provide relevant documents, including the country (region) where the place of registration or place of production is located to allow the product to be marketed Proof of sales.

   Innovative medical devices that have not been marketed in the country (region) where the applicant, the filing person is registered or where the place of production is located, do not need to submit relevant documents.

   Article 19 Medical devices shall comply with applicable mandatory standards. If the product structure characteristics, intended use, usage method, etc. are inconsistent with the scope of application of the mandatory standards, the applicant and filing party shall provide an explanation on the non-applicability of the mandatory standards and provide relevant materials.

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

   Article 20 The registration and filing of medical devices shall follow the relevant requirements of the medical device classification rules and classification catalogs.

Article 21 The drug regulatory department continues to promote the reform of the review, review and approval system, strengthen scientific research on medical device supervision, and establish a medical device registration management technology system based on technical review and evaluation, and supported by verification, inspection, monitoring and evaluation. Optimize the review, review and approval process, improve review, review and approval capabilities, and improve the quality and efficiency of review, review and approval.

   Article 22 The medical device professional technical institution shall establish a sound communication system, clarify the form and content of communication, and organize communication 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 in the process of review, verification, and inspection, and give full play to the technical support role of experts.

   Chapter III Medical Device Registration

   Section 1 Product Development

Article 24 The development of medical devices shall follow the principles of risk management, consider the current recognized technical level, ensure that all known and foreseeable risks and unanticipated effects of the product are minimized and acceptable, and that the benefits of the product during normal use outweigh the risks. .

   Article 25 Anyone engaged in the research and development of medical device products shall comply with the requirements of relevant Chinese laws, regulations and mandatory standards.

   Article 26 The applicant and the filing person shall compile the product technical requirements for the application for registration or the filing of medical devices.

  Product technical requirements mainly include functional, safety indicators and testing methods that can be objectively judged for finished medical devices.

  Medical devices should meet the product technical requirements that have been registered or filed.

   Article 27 The applicant and the filing party shall prepare the product manuals and labels of the medical devices applying for registration or filing.

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

   Article 28 In the development of medical devices, non-clinical research on medical devices shall be carried out in accordance with the scope of application and technical characteristics of the products.

  Non-clinical research includes product chemical and physical performance research, electrical safety research, radiation safety research, software research, biological characteristics research, biological source material safety research, disinfection and sterilization process research, animal test research, stability research, etc.

   When applying for registration or filing, non-clinical evidence generated during research and development activities shall 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 in the non-clinical research process of medical devices should be compatible with the expected use conditions and purposes of the product, and the research samples should be representative and typical. When necessary, methodological verification and statistical analysis shall be carried out.

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

   Article 31 The products for inspection shall be able to represent the safety and effectiveness of the products applying for registration or filing, and their production shall comply with the relevant requirements of the medical device production quality management regulations.

   Article 32 The medical device product inspection report submitted for registration or filing may be a self-inspection report of the applicant or filing person, or an inspection report issued by a qualified medical device inspection agency.

  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 be subject to clinical evaluation.

   Clinical evaluation of medical devices refers to the use of scientific and reasonable methods to analyze and evaluate clinical data 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 Those who have one of the following circumstances may be exempt from clinical evaluation:

   (1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same variety that have been marketed have been clinically used for many years, there is no record of serious adverse events, and the conventional use is not changed;

   (2) Other non-clinical evaluations that can prove that the medical device is safe and effective.

   Those who are exempt from clinical evaluation can be exempted from submitting clinical evaluation data.

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

Article 35 The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment. The safety and effectiveness of the device.

  In accordance with the regulations of the State Drug Administration, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, clinical trials should be carried out.

   The National Medical Products Administration has formulated guidelines for clinical evaluation of medical devices, clarifying the requirements for clinical evaluation through the clinical literature and clinical data of the same type of medical devices, the circumstances in which clinical trials need to be carried out, and the requirements for writing clinical evaluation reports.

Article 36 For clinical evaluations based on the clinical documentation and clinical data of the same variety of medical devices, the clinical evaluation data includes the comparison between the product applied for registration and the same variety of medical devices, the analysis and evaluation of the clinical data of the same variety of medical devices, and the comparison between the product applied for registration and the Scientific evidence and evaluation conclusions when there are differences between products of the same variety.

   If clinical evaluation is carried out through clinical trials, the clinical evaluation materials include clinical trial protocols, ethics committee opinions, informed consent, clinical trial reports, etc.

  Article 37 The clinical trials of medical devices shall be carried out in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with the requirements in accordance with the requirements of the medical device clinical trial quality management regulations. Before the start of a clinical trial, the clinical trial sponsor shall file a clinical trial record with the local drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government. The production of clinical trial medical devices shall meet the relevant requirements of the medical device production quality management norms.

   Article 38 Clinical trials of Class III medical devices that have a higher risk to humans shall be approved by the State Drug Administration.

Clinical trial approval refers to the comprehensive analysis of the medical device's risk level, clinical trial plan, clinical benefit and risk comparative analysis report, etc., based on the applicant’s application by the National Medical Products Administration, in order to decide whether to approve the clinical trial. The process of testing.

  The catalog of the third category of medical devices requiring clinical trial approval is formulated, adjusted and published by the State Drug Administration. The third-class medical device clinical trials that require clinical trial approval should be carried out in third-class medical institutions that meet the requirements.

  Article 39 Where medical device clinical trial approval is required, the applicant shall submit application materials such as summary materials, research materials, clinical materials, product instructions, and label samples in accordance with relevant requirements.

   Article 40 The Device Evaluation Center of the State Administration of China shall review the accepted clinical trial applications. Application for clinical trial

The decision of whether to agree or not shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the National Bureau of Equipment Evaluation Center. Failure to notify within the time limit shall be deemed as consent.

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

   If the applicant has objections to the contents of the notice of supplementation and correction, he can submit written opinions to the National Bureau of Equipment Evaluation Center, explain the reasons and provide corresponding technical support materials.

   If the applicant fails to submit supplementary materials within the 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 during the clinical trial of medical devices, or other serious safety risk information, the clinical trial sponsor shall, in accordance with relevant requirements, report to the province and autonomous region where the clinical trial institution is located. , The municipal drug supervision and administration department reports and adopts risk control measures. If no risk control measures are taken, the drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law.

Article 43 When a large-scale clinical trial medical device-related serious adverse event occurs in a medical device clinical trial, or other major safety issues, the sponsor shall suspend or terminate the medical device clinical trial, and report to the province where the clinical trial institution is located. , Autonomous regions and municipalities directly under the Central Government's drug supervision and administration department reports. If it is not suspended or terminated, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law.

   Article 44 For the clinical trials that have been approved for carrying out, in any of the following circumstances, the State Drug Administration may order the applicant to terminate the medical device clinical trials that have been carried out:

   (1) The clinical trial application materials are false;

   (2) The latest research has confirmed that there are problems with the ethics and science of the originally approved clinical trial;

   (3) Other circumstances that should be terminated.

   Article 45 The clinical trial of a medical device shall be carried out within 3 years after approval; the clinical trial application for a medical device shall be automatically invalidated if no subject has signed an informed consent within 3 years from the date of approval. If clinical trials are still needed, a new application should be made.

Article 46 For medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatments, medical observations may benefit patients. After ethical review and informed consent, medical devices can be used for medical treatment. The device clinical trial institution is free for other patients with the same condition, and its safety data can be used for medical device registration applications.

   Section III Registration System Verification

Article 47 The applicant shall submit relevant materials related to the quality management system related to product development and production when applying for registration. The drug regulatory authority accepting the registration application considers it necessary to check the quality management system during the technical review of the product. , Should organize and carry out the quality management system verification, and can read the original data as needed.

  Article 48 The inspection of the quality management system of domestic Class III medical devices shall be carried out by the National Bureau of Device Evaluation Center notifying the applicant's drug regulatory department in the province, autonomous region, or municipality where the applicant is located.

   The domestic second-class medical device quality management system verification is organized and carried out by the drug regulatory department of the province, autonomous region, or municipality where the applicant is located.

Article 49 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall carry out quality management system verification in accordance with the requirements of the medical device production quality management specifications, focusing on whether the applicant has established a quality compatible with the product in accordance with the requirements of the medical device production quality management specifications The management system, as well as the design and development, production management, quality control and other content related to product development and production are checked.

   During the verification process, the authenticity of the inspection products and clinical trial products should be verified at the same time, with emphasis on reviewing the relevant records of the design and development process, as well as the relevant records of the production process of the inspection products and clinical trial products.

   Where a self-inspection report is submitted, the applicant, the filing person or the trustee institution shall conduct key inspections on the inspection capabilities and inspection results during the development process.

   Article 50 The drug regulatory department of provinces, autonomous regions, and municipalities directly under the Central Government may conduct quality management system verification through document review or on-site inspection. According to the applicant's specific situation, supervision and inspection, the product applied for registration this time and the previous inspection product production conditions and process comparison, etc., determine whether on-site inspection and inspection content, to avoid repeated inspections.

   Article 51 When the National Bureau’s Device Review Center conducts technical review of imported Class II and Class III medical devices, if it considers it necessary to conduct quality management system verification, it shall notify the National Bureau of Review and Inspection Center to conduct verification in accordance with relevant requirements.

   Section 4 Product Registration

Article 52 The applicant shall submit an application for medical device registration after completing the safety and effectiveness research supporting the registration of medical devices and being ready to accept the verification of the quality management system, and submit an application for medical device registration in accordance with relevant requirements through online registration applications, etc. Submit the following registration application materials to the drug regulatory authority:

   (1) Product risk analysis data;

   (2) Product technical requirements;

  (3) Product inspection report;

   (4) Clinical evaluation data;

   (5) Product manuals and label samples;

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

  (7) Other materials needed to prove that the product is safe and effective.

   Article 53 After receiving the application, the drug regulatory authority shall review the application materials and deal with it separately according to the following conditions:

   (1) The application items are within the scope of the administrative agency's powers, and the application materials are complete and meet the formal review requirements, they will be accepted;

   (2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;

   (3) If the application materials are incomplete or do not conform to the legal form, the applicant shall be notified on the spot or within 5 days of all the contents that need to be supplemented and corrected. If the notification is not given within the time limit, the application shall be accepted as of the date of receipt of the application materials;

  (4) If the application matters are not within the scope of the administrative agency's powers in accordance with the law, it shall immediately make a decision of disapproval and inform the applicant to apply to the relevant administrative agency.

   When the drug regulatory authority accepts or rejects the medical device registration application, it shall issue a notice of acceptance or non-acceptance affixed with the special seal of the administrative agency and dated.

   After the medical device registration application is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee 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 withdrawn the application voluntarily, and the drug regulatory authority shall terminate its registration procedure.

   Article 54 If the applicant needs to supplement and correct the materials during the technical review process, the technical review agency shall notify all the contents that need to be supplemented and corrected at one time. The applicant shall provide supplementary materials in accordance with the requirements of the supplementary notice once within one year after receiving the notice of supplementary correction; the technical review agency shall complete the technical review within the prescribed time limit after receiving the supplementary materials.

   If the applicant disagrees with the contents of the notice of supplementation and correction, he may submit written opinions to the corresponding technical review agency, explain the reasons and provide corresponding technical support materials.

   If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated and the drug regulatory authority shall make a decision not to approve the registration.

   Article 55 For an accepted registration application, the applicant may apply to the drug regulatory authority that accepted the application to withdraw the registration application and related materials, and explain the reasons before the administrative licensing decision is made. If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure.

   In the process of review, verification, and approval, if any illegal act is found to be suspected of concealing the truth or providing false information, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the medical device registration application.

   Article 56 For the accepted registration application, if there is evidence that the registration application materials may be false, the drug regulatory authority may suspend the review and approval. After verification, continue to review or make a decision not to grant registration based on the verification conclusion.

Article 57 During the review of a medical device registration application, if a review conclusion that is to be rejected is to be made, the technical review agency shall inform the applicant of the reason for the rejection, and the applicant may raise an objection to the technical review agency within 15 days , The content of the objection is limited to the original application items and original application materials. The technical review agency conducts a comprehensive evaluation based on the applicant’s objections and gives feedback to the applicant. The objection processing time is not included in the review time limit.

   Article 58 The drug regulatory authority that accepts the registration application shall make a decision on whether to approve it after the technical review is completed. For those that meet the requirements of safety, effectiveness, and quality control, registration is approved and a medical device registration certificate is issued, and the approved product technical requirements are issued to the applicant in the form of an attachment. If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

   The medical device registration certificate is valid for 5 years.

   Article 59 For the accepted registration application, if one of the following situations occurs, the drug regulatory authority shall make a decision not to approve the registration and notify the applicant:

   (1) The applicant's research on the safety, effectiveness, and quality controllability of the medical device to be marketed and its results cannot prove that the product is safe, effective, and quality controllable;

   (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 confusing and contradictory, and the content of the registration application materials is obviously inconsistent with the application items, and the product cannot be proved to be safe, effective, and controllable in quality;

   (5) Other situations where registration is not granted.

   Article 60 For matters that laws, regulations, and rules stipulate that the implementation of administrative licensing should be subject to a hearing, or other major administrative licensing matters that involve public interest that the drug regulatory authority considers to require a hearing, the drug regulatory authority shall make an announcement to the public and hold a hearing. If the medical device registration application directly involves the significant relationship of interest between the applicant and others, the drug regulatory authority 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 that are urgently needed for the treatment of rare diseases, serious life-threatening diseases without effective treatment, and response to public health events, the drug regulatory authority may make a conditional approval decision and register the medical device. The certificate specifies the validity period, the research work that needs to be completed after the listing, and the time limit for completion and other related matters.

Article 62 For medical devices approved with conditions, the registrant shall collect data on benefits and risks after the medical devices are on the market, continue to monitor and evaluate the benefits and risks of the products, take effective measures to actively manage and control risks, and stipulate Complete the research and submit relevant materials as required within the time limit.

Article 63 For conditionally approved medical devices, if the registrant fails to complete the research as required or cannot prove that the benefits are greater than the risks, the registrant shall promptly apply for the cancellation of the medical device registration certificate, and the drug regulatory authority may cancel it in accordance with the law. Medical device registration certificate.

Article 64 For newly developed medical devices that have not yet been included in the classification catalog, the applicant may directly apply for the registration of the third category of medical device products, or may determine the product category according to the classification rules and apply to the State Drug Administration for category confirmation. , Apply for product registration or product filing.

   For directly applying for the third-class medical device registration, the State Drug Administration shall determine the category according to the degree of risk. If a domestic medical device is determined to be in the second or first category, the applicant shall be notified to apply for registration or record filing with the corresponding drug regulatory authority.

   Article 65 For a registered medical device whose management category is adjusted from a high category to a low category, the medical device registration certificate shall continue to be valid during the validity period. If the validity period expires and needs to be renewed, the medical device registration certificate shall be applied to the corresponding drug regulatory authority for renewal of registration or filing in accordance with the adjusted category 6 months before the expiration of the validity period of the medical device registration certificate.

   If the medical device management category is adjusted from a low category to a high category, the registrant shall apply to the corresponding drug regulatory authority for registration in accordance with the changed category. The State Drug Administration shall stipulate the time limit for completing the adjustment in the notice of adjustment of the management category.

   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 reissuance, which shall be reissued after verification by the original issuing authority.

   Article 67 Where patent rights disputes occur during the examination of registration applications and after approval, they shall be handled in accordance with relevant laws and regulations.

   Chapter 4 Special Registration Procedure

   Section 1 Innovative Product Registration Procedure

   Article 68 For medical devices that meet the following requirements, the applicant may apply for the applicable innovative product registration procedures:

(1) The applicant, through its leading technological innovation activities, has legally owned product core technology invention patents in China, or obtained invention patents in China or the right to use them through transfers in accordance with the law, and the time to apply for the application of innovative product registration procedures Within 5 years from the date of the announcement of the patent authorization; or the application for the core technology invention patent has been published by the Patent Administration Department of the State Council, and a search report issued by the Patent Search and Consultation Center of the State Intellectual Property Office, stating that the core technical solution of the product is novel and creative;

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

  (3) The main working principle or mechanism of the product is a domestic initiative. The performance or safety of the product is fundamentally improved compared with similar products. It is at the international leading level in technology and has significant clinical application value.

   Article 69 To apply for the application of innovative product registration procedures, the applicant shall submit an application for review of innovative medical devices to the State Drug Administration after the product is basically finalized. The State Drug Administration organizes experts to review, and those that meet the requirements are included in the innovative product registration procedure.

   Article 70 For medical device registration applications that are subject to innovative product registration procedures, the National Medical Products Administration and the institutions responsible for related technical work shall designate special persons to be responsible for their respective responsibilities, communicate in a timely manner, and provide guidance.

For medical devices that are included in the innovative product registration procedures, the National Bureau’s Device Evaluation Center can discuss with the applicant major technical issues, major safety issues, clinical trial plans, and phased issues in product development before the registration application is accepted and during the technical review process. Communicate on the summary and evaluation of clinical trial results.

Article 71. For medical devices that are included in the innovative product registration procedure, if the applicant actively requests termination or the State Drug Administration finds that it no longer meets the requirements of the innovative product registration procedure, the State Drug Administration shall terminate the relevant product’s innovative product registration procedure and Inform the applicant.

   Article 72 For medical devices that are included in the innovative product registration procedure, if the applicant fails to file a registration application within the prescribed time limit, the innovative product registration procedure will no longer apply.

  Section 2 Priority Registration Process

sequence

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

(1) Diagnosis or treatment of rare diseases and malignant tumors with obvious clinical advantages, diagnosis or treatment of peculiar and multiple diseases of the elderly and there is currently no effective diagnosis or treatment method, dedicated to children with obvious clinical advantages, or clinically urgently needed and in There is no medical device with the same product type approved for registration in my country;

   (2) Medical devices listed in major national science and technology projects or national key research and development plans;

  (3) Other medical devices for which priority registration procedures are applicable as prescribed by the State Drug Administration.

   Article 74 Where the priority registration procedure is applied for, the applicant shall submit an application for the priority registration procedure to the State Drug Administration when submitting an application for medical device registration. In the case of the first item of Article 73, the State Drug Administration shall organize experts to conduct the review, and those that are in line will be included in the priority registration procedure; in the case of the second item of Article 73, the National Bureau of Device Evaluation Center Upon review, those that are in compliance will be included in the priority registration procedure; in the case of the third item of Article 73, the State Drug Administration will listen to opinions extensively and organize experts to determine whether to be included in the priority registration procedure.

  Article 75 For medical device registration applications that are included in the priority registration procedure, the National Medical Products Administration will give priority to review and approval, and the drug regulatory authorities of provinces, autonomous regions, and municipalities will give priority to medical device registration quality management system verification.

  In the process of technical review of medical device products that are included in the priority registration procedure, the National Bureau’s Device Evaluation Center shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary.

   Section 3 Emergency Registration Procedure

Article 76 The State Drug Administration may respond to public health emergencies in accordance with the law, and there is no similar product on the market in my country, or although similar products have been listed in my country, the product supply cannot meet the needs of public health emergencies. Emergency registration of medical devices required for emergency handling of incidents.

   Article 77 To apply for emergency registration procedures, the applicant shall submit an emergency registration application to the State Drug Administration. Those who meet the conditions shall be included in the emergency registration procedure.

Article 78 For medical device registration applications for emergency registration, the National Medical Products Administration shall handle the requirements of unified command, early intervention, follow-up review, and scientific approval, and conduct medical device product inspection, system verification, and technical review in parallel. Rating work.

   Chapter 5 Change of Registration and Renewal of Registration

   Section 1 Change of Registration

   Article 79 The registrant shall actively carry out post-market research on medical devices, further confirm the safety, effectiveness and quality controllability of medical devices, and strengthen the continuous management of medical devices already on the market.

If the design, raw materials, production process, scope of application, method of use, etc. of registered medical device products of Class II and Class III undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall report to the original registration department. Apply to go through the formalities of changing the registration; if there are other changes, it shall be filed with the original registration department within 30 days from the date of the change.

   The product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. stated in the registration certificate are the items that need to be changed and registered as stipulated in the preceding paragraph. The name and domicile of the registrant, the name and domicile of the agent, etc., are matters that need to be filed as prescribed in the preceding paragraph. If the domestic medical device production address is changed, the registrant shall file for the record after handling the corresponding production license change.

  In case of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with the regulations.

   Article 80 For an application for registration of a change, the technical review agency shall focus on the review of the changed part, and form an review opinion on whether the product after the change is safe, effective, and controllable in quality.

  In the technical review of the application for change registration, if it is deemed necessary to verify the quality management system, the drug regulatory authority shall organize the quality management system verification.

   Article 81 The medical device modification registration document is used in combination with the original medical device registration certificate, and the expiration date is the same as the original medical device registration certificate.

   Section 2 Renewal of registration

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

   Except for the circumstances stipulated in Article 83 of these Measures, the drug regulatory authority that receives an application for renewal of registration shall make a decision to approve the renewal before the expiration of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed that the renewal is approved.

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

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

   (2) The new mandatory standards for medical devices are issued and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements;

   (3) For conditionally approved medical devices, the items specified in the medical device registration certificate have not been completed within the prescribed time limit.

Article 84 If the approval time for renewal of registration is within the validity period of the original registration certificate, the start date of the validity period of the renewal registration certificate shall be the day following the expiration date of the original registration certificate; if the approval time is not within the validity period of the original registration certificate, the registration of the renewal registration shall be renewed The starting date of the validity period of the certificate is the date of approval to renew the registration.

   Article 85 The procedures for the acceptance and approval of medical device modification registration applications and renewal registration applications, which are not provided for in this chapter, shall be subject to the relevant provisions of Chapter 3 of these Measures.

   Chapter VI Medical Device Filing

   Article 86 Prior to the production of Class I medical devices, product filing shall be carried out.

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

  Article 88 If the contents of the record information form and the technical requirements of the record products are changed for the registered medical devices, the recorder shall change the record to the original record department, and submit the explanation of the change and related documents. The drug supervision and administration department shall post the changes in the record information.

   Article 89 If the registered medical device management category is adjusted to the second or third category of medical devices, it shall apply for registration in accordance with the provisions of these Measures.

   Chapter 7 Working Time Limit

   Article 90 The time limit stipulated in these Measures is the maximum time for the acceptance, technical review, verification, and approval of medical device registration. The working time limit for the special registration procedure shall be implemented in accordance with the relevant regulations of the special registration procedure.

   Professional technical institutions such as the Device Evaluation Center of the National Bureau shall clarify the working procedures and time limit of the unit, and announce it to the public.

   Article 91 After receiving the medical device registration application and clinical trial application, the drug regulatory authority shall forward the application materials to the technical review agency within 3 days from the date of acceptance. The acceptance requirements for clinical trial applications shall apply to the provisions of Article 53 of these Measures.

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

   (1) The technical review time limit for the medical device clinical trial application is 60 days, and the technical review time limit after the application materials are supplemented and corrected is 40 days;

   (2) The technical review time limit for the second category medical device registration application, registration change application, and registration renewal application is 60 days, and the time limit for technical review after the application materials are supplemented and corrected is 60 days;

   (3) The technical review time limit for the third category medical device registration application, registration change application, and registration renewal application is 90 days, and the time limit for technical review after the application materials are supplemented and corrected is 60 days.

   Article 93 The time limit for the verification of the domestic Class III medical device quality management system shall be implemented in accordance with the following regulations:

   (1) The National Bureau’s Device Evaluation Center shall notify the relevant provinces, autonomous regions, and municipalities to initiate the inspection within 10 days after the medical device registration application is accepted;

   (2) In principle, the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall complete the inspection within 30 days after receiving the inspection notice, and feed back relevant materials such as inspection results and inspection results to the National Bureau of Device Evaluation Center.

   Article 94 The drug regulatory authority that accepts the registration application shall make a decision within 20 days from the date of receipt of the review comments.

   Article 95 The drug supervision and administration department shall issue and serve the relevant administrative license within 10 days from the date of making the medical device registration approval decision.

Article 96 If it is necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification work, the extended time limit shall not exceed one-half of the original time limit. After the medical device technical review, verification and other relevant technical institutions After the person in charge approves, the technical agency that extended the time limit shall notify the applicant in writing and notify other relevant technical agencies.

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

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

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

   (2) Delay in the verification time due to the applicant;

   (3) Consultation with external experts, holding expert consultation meetings, and the time required for joint review of drug-device combination products with drug review agencies;

   (4) If the review, review and approval procedure is suspended in accordance with regulations, the time taken during the suspension of the review, review and approval procedure;

   (5) Time spent on quality management system verification.

   Article 99 The time limit stipulated in these Measures is calculated based on working days.

   Chapter 8 Supervision and Management

Article 100 The drug regulatory authority shall strengthen the supervision and inspection of medical device research and development activities. When necessary, it may conduct extended inspections on units and individuals that provide products or services for medical device research and development. Relevant units and individuals shall cooperate and provide relevant documents. And materials, no rejection, concealment, or obstruction.

  Article 101 The National Medical Products Administration establishes and implements a unique identification system for medical devices step by step. Applicants and recorders shall submit unique identification related information in accordance with relevant regulations to ensure that the data is true, accurate and traceable.

   Article 102 The State Drug Administration shall promptly notify the agent's information to the drug regulatory department of the province, autonomous region, or municipality where the agent is located. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government organize daily supervision and management of agents in their respective administrative regions.

  Article 103 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall organize post-filing supervision and inspection of clinical trial institutions that have been filed in their respective administrative regions based on the filing status of medical device clinical trial institutions. For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after the filing.

  The drug supervision and administration 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 in their administrative regions with the medical device clinical trial quality management regulations, and supervise their continued compliance with the prescribed requirements. The State Drug Administration shall supervise and inspect medical device clinical trial institutions as required.

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

   Article 105 The drug regulatory authority responsible for the filing of Class I medical device products shall, in the post-filing supervision, find that the filing materials are not standardized, it shall order the filing party to make corrections within a time limit.

Article 106 If the drug supervision and administration department fails to discover the medical device registration management systemic and regional risks in the administrative area in time, or fails to eliminate the medical device registration management systemic and regional risks in the administrative area in time, the higher-level drugs The supervisory and administrative department may conduct interviews with the main persons in charge of the lower-level drug supervisory and administrative departments.

   Chapter 9 Legal Liability

   Article 107 Anyone who violates the provisions of Article 79 of these Measures and fails to file the changes in accordance with the requirements shall be ordered to make corrections within a time limit; if the corrections are not made within the time limit, a fine of 10,000 yuan to 30,000 yuan shall be imposed.

   Article 108 Anyone who fails to comply with the clinical trial quality management standards when conducting 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 the medical device technical review agency fails to perform its duties in accordance with the provisions of these Measures, causing major errors in the review work, the department responsible for drug supervision and administration shall order corrections, notify criticisms, and give warnings; if serious consequences are caused, The legal representative, main responsible person, directly responsible person in charge, and other responsible persons of the illegal unit shall be punished in accordance with the law.

   Article 110 If the staff of the department responsible for drug supervision and management violates the regulations, abuses their power, neglects their duties, or engages in malpractice for personal gain, they shall be punished in accordance with the law.

   Chapter Ten Supplementary Provisions

   Article 111 The medical device registration or filing unit shall in principle be divided based on the technical principle, structural composition, performance index and scope of application of the product.

   Article 112 The medical device approved for registration refers to the medical device that is consistent with the content of the medical device registration certificate and accessories and is produced within the validity period of the medical device registration certificate.

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

  Article 114 When applying for medical device product registration, change registration, and clinical trial approval, the applicant may be authorized by the owner of the medical device master file to cite the registered medical device master file. The work procedures related to the registration of the master file of medical devices shall be stipulated separately.

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

  The arrangement method of the registration certificate number is:

  ×1 Machine Note×2××××3×4××5××××6. in:

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

  Domestic Class III medical devices, imported Class II and Class III medical devices are the word "國";

  The second category of domestic medical devices is the abbreviation of the province, autonomous region, or municipality where the registration approval department is located;

  ×2 is the registration form:

  The word "quasi" applies to domestic medical devices;

   The word "進" applies to imported medical devices;

   The word "許" is applicable to medical devices in Hong Kong, Macau, and Taiwan;

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

  ×4 is the product management category;

  ××5 is the product classification code;

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

   If the registration is continued, the numbers of ××××3 and ××××6 remain unchanged. If the product management category is adjusted, it shall be renumbered.

   Article 116 The arrangement of the first-class medical device registration number is as follows:

  ×1 Equipment ××××2××××3. in:

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

  Imported Class I medical devices are the word "國";

  The first category of medical devices in the country is the abbreviation of the province, autonomous region, or municipality where the filing department is located, plus the abbreviation of the municipal administrative area where the district is located (when there is no corresponding municipal administrative area divided into districts, only the abbreviation of the province, autonomous region, or municipality);

  ××××2 is the filing year;


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