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State Administration for Market Regulation Decree No. 48

source:互聯網   release time: 2021-09-13 11:28:25   Browsing:504次  Font size: [大] [中] [小]
State Administration for Market RegulationAdministrative Measures for Registration and Filing of In-vitro Diagnostic ReagentsCHAPTER 1 GeneralArticle 1This Measures is formulate

State Administration for Market Regulation

Decree No. 48


Administrative Measures for Registration and Filing of In-vitro Diagnostic Reagents

CHAPTER 1 General

Article 1 This Measures is formulated according to the Regulations on the Supervision and Administration of Medical Devices, aiming to regulate the registration and filing of in-vitro diagnostic reagents (IVD reagents) and ensure their safety, effectiveness and controllable quality.

Article 2 This Measures shall apply to the registration, filing and supervision and administration of IVD reagents within the territory of the People's Republic of China.

Article 3 The IVD reagents mentioned herein refer to IVD reagents administered as medical devices, including reagents, reagent kits, calibration, quality control products, etc. for in-vitro examination of specimens derived from human body in the course of disease prediction, prevention, diagnosis, treatment and monitoring, prognosis observation, and health status evaluation, which can be used independently or in combination with instruments, apparatus, equipment or systems.

IVD reagents for blood screening and IVD reagents with radionuclide labeling, both administered as drugs, shall not be under the regulation scope of this Measures.

Article 4 IVD reagents registration is the process of IVD reagents registration applicant (hereinafter referred to as the "Applicant") submitting an application for IVD reagents registration according to legal procedures and requirements, and the drug supervision and administration department, in accordance with laws and regulations and based on scientific cognition, carrying out review on the safety, effectiveness and quality controllability of IVD reagents to decide whether to approve such application.

IVD reagents filing is the process of IVD reagents filing registrant (hereinafter referred to as "filing registrant") submitting filing materials to the drug supervision and administration department, in accordance with legal procedures and requirements, and the drug supervision and administration department filing the submitted filing materials for future reference.

Article 5 National Medical Products Administration (NMPA) is in charge of the registration and filing management of IVD reagents nationwide, and is responsible for establishing the registration and filing management system of IVD reagents, organizing the review and approval of domestic Class III and imported Class II and Class III IVD reagents, the filing of imported Class I IVD reagents and related supervision and administration work according to law, and supervising and guiding the registration and filing of local IVD reagents.

Article 6 The Center for Medical Device Evaluation of NMPA (hereinafter referred to as the CMDE of NMPA) is responsible for the technical review of the application for registration, change of registration and renewal of registration of domestic Class III and imported Class II and Class III IVD reagent products.

Center for Medical Device Standards Administration NMPA, National Institutes for Food and Drug Control, Center for Food and Drug Inspection of NMPA (hereinafter referred to as Inspection Center of NMPA), Center for Drug Re-evaluation of NMPA, Administrative Matters Acceptance Service and Complaint Reporting Center of NMPA, Information Center of NMPA and other professional and technical institutions undertake the management, classification, definition, inspection, verification, monitoring and evaluation, certification preparation and delivery of IVD reagents standards required for the implementation of IVD reagents supervision and administration as well as corresponding information construction, management and related work.

Article 7 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the registration of the following IVD reagents within their respective administrative areas:

(I) Review and approval of registration of Class II IVD reagents in China;

(II) Verification of Quality Management System of Class II and Class III IVD reagents in China;

(III) Organization of the supervision and administration of medical device clinical trial institutions and clinical trials according to law;

(IV) Supervision and guidance on the filing of Class I IVD reagents within the territory of the departments responsible for drug supervision and administration at the municipal level divided into districts.

The professional technical institutions for medical devices set or designated by the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government shall take charge of the technical review, inspection, validation, monitoring and evaluation required for the implementation of IVD reagents supervision and administration according to law.

The departments in charge of drug supervision and administration at the municipal level divided into districts are responsible for the filing management of Class I IVD reagent products in China.

Article 8 The IVD reagents registration and filing shall be conducted under the principles of legality, science, openness, fairness and justice.

Article 9 The Class I IVD reagents shall be subject to product filing management. The Class II and Class III IVD reagents shall be subject to product registration management.

When filing the domestic Class I IVD reagents, the filing registrant shall submit filing documents to the drug supervision and administration department at the municipal level divided into districts.

Domestic Class II IVD reagents shall be subject to review by drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and Medical Device Registration Certificates will be issued after approval by such departments.

Domestic Class III IVD reagents shall be subject to review by the NMPA, and Medical Device Registration Certificates will be issued after approval by the NMPA.

When filing the imported Class I IVD reagents, the filing registrant shall submit filing documents to the NMPA.

Imported Class II and Class III IVD reagents shall be subject to review by the NMPA, and Medical Device Registration Certificates will be issued after approval by the NMPA.

Article 10 IVD reagents registration applicants or filing registrants shall strengthen the life cycle management of IVD reagents, and shall be legally responsible for the safety, effectiveness and quality controllability of IVD reagents in the whole process of research and development, production, operation and use.

Article 11 The NMPA implements priority review and approval for clinically urgent- needed IVD reagents, and conducts special review and approval for innovative IVD reagents. Research and innovation of IVD reagents shall be encouraged, so as to promote the high-quality development of medical device industry.

Article 12 The NMPA shall establish and improve systems such as IVD reagents standards and technical guidelines, regulate the technical review of IVD reagents and verification of quality management systems, and guide and serve the research and development and registration application of IVD reagents.

Article 13 The drug supervision and administration department shall disclose the relevant information on the registration and filing of IVD reagents in a timely manner according to law. Applicants can inquire about the progress and results of review and approval, and the public can consult the review and approval results.

Without the consent of the applicant, the drug supervision and administration department, professional and technical institutions and their staff, experts participating in the review and other personnel shall not disclose the trade secrets, undisclosed information or confidential business information submitted by the applicant or the filing applicant, except as otherwise specified by law or involving national security and major social and public interests.


CHAPTER 2 Basic Requirements

Article 14 The registration and filing of IVD reagents shall comply with relevant laws, regulations, rules and mandatory standards, follow the basic principles of safety and performance of IVD reagents, and refer to relevant technical guidelines to prove that the registered and filed IVD reagents are safe, effective and controllable in quality, so as to ensure the truthfulness, accuracy, completeness and traceability of information.

Article 15 Applicants and filing registrants shall be enterprises or research institutions that can bear corresponding legal responsibilities.

Overseas applicants and filing registrants shall designate enterprise legal persons in China as agents to handle the registration and filing of relevant IVD reagents. The agent shall assist the registrants and filing applicants to fulfill the obligations specified in paragraph 1 of Article 20 of the Regulations on the Supervision and Administration of Medical Devices, and assist the overseas registrants and filing applicants to implement the corresponding legal responsibilities.

Article 16 The registration applicant and filling registrant shall establish the quality management system related to product research and development and manufacture, and shall keep its effective operation.

Article 17 Personnel in charge of IVD reagents registration or filing affairs shall have relevant expertise and be familiar with laws, regulations, rules and registration administration concerning IVD reagents registration and filing management.

Article 18 When applying for registration or filing, the applicant or filing registrant shall submit relevant materials in accordance with the requirements for registration and filing of the NMPA, and shall be responsible for the authenticity of the materials.

The registration and filing materials shall be in Chinese language. Source text shall also be provided for translations from foreign language materials. For references of unpublished literatures, proof of permission by copyright owner of the literatures shall be provided.

Article 19 When applying for registration of imported IVD reagents and the filing of imported IVD reagents, the supporting documents for the marketing approval issued by the competent authorities of the country (region) where the applicant and the filing registrant are registered or where the production address is located shall be submitted.

If the country (region) where the registered place or production address of the overseas applicant does not manage this product as medical device, the applicants and filing applicants need to provide relevant certificates, including certificates issued by the said country (region) permitting the marketing of this product.

For IVD reagents reviewed and approved in accordance with the innovative product registration procedures that are not marketed in the country (region) where the applicant or filling registrant is registered or where the place of production is located, relevant documents are not required to be submitted.

Article 20 IVD reagents should meet the applicable mandatory standards. If the product structure characteristics, technical principles, intended use and usage methods are inconsistent with the applicable scope of mandatory standards, the applicant and the filling registrant shall put forward an explanation of the non-application of mandatory standards and provide relevant information.

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

Article 21 The registration and filing of IVD reagents shall follow the relevant requirements of the classification rules and classification catalogue of IVD reagents.

Article 22 The NMPA has continuously promoted the reform of the review and approval system, strengthened scientific research on IVD reagents supervision and administration, established a IVD reagents registration management system led by technical review and supported by verification, inspection, monitoring and evaluation, optimized the review and approval process, improved the ability, quality and efficiency of review and approval.

Article 23 The professional and technical institutions of medical devices shall establish and improve the communication system, clarify the form and content of communication, and organize communication with the applicant according to work needs.

Article 24 Professional technical institutions of medical devices 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 3 Registration of IVD Reagents

Section I Product research and development

Article 25 The research and development of IVD reagents should follow the risk management principles and consider the existing recognized technical level, so as to ensure that all known and foreseeable risks and unexpected impacts of products are minimized and acceptable, and ensure that the benefits of products outweigh the risks in normal use.

Article 26 The research and development and experimental activities of IVD reagent products shall meet the requirements of relevant laws, regulations and mandatory standards in China.

Article 27 The applicant and the filling registrant shall prepare the product technical requirements for applying for registration or IVD reagents.

The technical requirements of the product mainly include the functionality, safety indicator and detection method of the finished product of IVD reagents which can be objectively judged.

Product technical requirements for Class III IVD reagents shall clearly specify requirements for main raw materials, production process in the form of appendices.

IVD reagents shall meet the product technical requirements of registered or filed products.

Article 28 The applicant and the filling registrant shall prepare the product instructions and labels of IVD reagents for registration or filing.

The product instructions and labels shall comply with the requirements of Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant provisions.

Article 29 In the research and development of IVD reagents, non-clinical study of IVD reagents should be carried out according to the intended use and technical features of products.

Non-clinical study refers to the test or evaluation of IVD reagents under laboratory conditions, including the selection and preparation of main raw materials, product production process, product analysis performance, positive judgment value or reference interval, product stability, etc.

To apply for registration or filing, non-clinical evidence generated in research and development activities shall be submitted.

Article 30 The performance and safety indicators and methods determined during the non-clinical study of IVD reagents shall be compatible with the intended use conditions and purposes of the products, and the study samples shall be representative and typical. If necessary, methodological verification and statistical analysis shall be carried out.

Article 31 When applying for registration or filing, 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 conduct clinical trials or apply for registration and filing.

Article 32 If the same registration application involves products in different packaging sizes, registration inspection may be done only with products in one packaging size. The products for inspection should represent the safety and effectiveness of the products to be registered or filed, and their production should meet the relevant requirements of the Good Manufacturing Practice for Medical Devices.

Article 33 The inspection report submitted for the registration application or filling can be the self-inspection report of the applicant or the filling registrant, or the inspection report issued by a qualified medical device testing institution.

For Class III IVD reagents, inspection reports of three different batches of products shall be provided.

Article 34 Where there are applicable national standards, the reagents shall be tested with the national standards. The National Institutes for Food and Drug Control should be responsible for the preparation and calibration of national standards.

Section II Clinical evaluation

Article 35 Clinical evaluation of IVD reagents refers to the process of analyzing and evaluating clinical data by scientific and reasonable methods, and confirming whether the products meet the use requirements or intended uses, so as to prove the safety and effectiveness of IVD reagents.

Article 36 Clinical trials of IVD reagents refer to the study process of confirming the clinical performance of IVD reagents in the corresponding clinical environment.

The NMPA has formulated guidelines for clinical trials of IVD reagents, specifying the requirements for conducting clinical trials and formulating clinical trial reports.

Article 37 To carry out clinical evaluation of IVD reagents, clinical trials should be conducted to prove the safety and effectiveness of IVD reagents.

Clinical trials may be exempted in the following conditions:

(I) With clear reaction mechanism, standardized design and mature manufacturing technique; the marketed IVD reagents of the same variety have been put in clinical application for years and there is no record of serious adverse events. In addition, the regulated use will not be changed;

(II) It can be proved that the IVD reagent is safe and effective by comparing the methodologies of the same variety.

The catalogue of Class II and Class III IVD reagents exempted from clinical trials shall be formulated, adjusted and issued by the NMPA.

Article 38 For IVD reagents exempted from clinical trials, the applicant shall prove the safety and effectiveness of the products by comparing the clinical samples that meet the intended use with the methodology of the same variety.

NMPA formulates relevant guidelines for clinical evaluation of IVD reagents exempted from clinical trials.

Article 39 Clinical evaluation data of IVD reagents refers to the documents formed by the applicant's clinical evaluation.

IVD reagents for clinical trials, clinical trial data include clinical trial protocol, opinions of ethics committee, informed consent, clinical trial report and relevant data, etc.

For IVD reagents listed in the catalogue of exemption from clinical trials, clinical evaluation data include comparative analysis with similar products on the market, methodological comparison data, relevant literature data analysis and empirical data analysis, etc.

Article 40 When the same registration application includes different packing specifications, products with one packing specification can be used for clinical evaluation, and the products for clinical evaluation should represent the safety and effectiveness of the products applied for registration or filed.

There is no need to submit clinical evaluation data when calibration and quality control products are applied separately.

Article 41 The clinical trials of IVD reagents shall be carried out in the medical device clinical trial institutions with required conditions and filed in accordance with the regulations in accordance with the requirements of Good Clinical Practice for Medical Devices. Before the commencement of the clinical trial, the clinical trial sponsor shall file the clinical trial project with the drug supervision and administration department at provincial level, autonomous regions and municipality level directly under the Central Government. The production of IVD reagents for clinical trials should meet the relevant requirements of the Good Manufacturing Practice for Medical Devices.

Article 42 For serious adverse events related to IVD reagents in clinical trials during clinical trials of IVD reagents, or other serious safety risk information, the clinical trial sponsor shall, in accordance with relevant requirements, report to the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the clinical trial institutions are located, and take risk control measures. If no risk control measures are taken, the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures according to law.

Article 43 In case of large-scale serious adverse events related to IVD reagents clinical trials during clinical trials of IVD reagents, or other major security issues, the sponsor shall suspend or terminate the clinical trials of IVD reagents, and report to the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the clinical trial institutions are located. If it has not been suspended or terminated, the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures according to law.

Article 44 When carrying out clinical evaluation of IVD reagents expected to be used by consumers themselves, the applicant should also evaluate the cognitive ability of consumers without medical background to product instructions.

Article 45 If an IVD reagent used to diagnosis of a serious life-threatening disease with no effective diagnosis means is under clinical trial and may benefit patients after medical observation, it can be used free of charge for other patients with the same condition in the institution where the clinical trial of the IVD reagent is being carried out after ethical review and informed consent, and their safety data can be used for application for IVD reagent registration.

Section III Verification of Registration System

Article 46 The applicant shall submit relevant materials related to the quality management system related to product research and development and production when applying for registration. If the drug supervision and administration department that accepts the application for registration considers it is necessary to verify the quality management system during the product technical review, it shall organize the quality management system verification and access the original data when necessary.

Article 47 The verification of the quality management system of Class III IVD reagents in China shall be carried out by the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located notified by the CMDE of NMPA.

The verification of the quality management system of Class II IVD reagents in China shall be carried out by the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 48 The drug supervision and administration department of provinces, autonomous regions and municipalities directly under the Central Government shall carry out quality management systems verification in accordance with the requirements of the Good Manufacturing Practice for Medical Devices, focusing on whether the applicant has established a quality management system suitable for the product in accordance with the requirements of the Good Manufacturing Practice for Medical Devices, and the design and development, production management and quality control related to product research and development and production.

During the process of verification, the authenticity of products for inspection and clinical trial products shall also be verified at the same time, focusing on checking the relevant records of the development process, as well as the relevant records of the production process of inspection products and clinical trial products.

Where a self-inspection report is submitted, key verification shall be carried out on the inspection capability and inspection results of the applicants and filing registrants or the entrusted institution in the process of research and development.

Article 49 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may carry out quality management systems verification by means of data review or on-site inspection. According to the specific situation of the applicant, the supervision and inspection situation, and the comparison results between the products applied for registration this time and the products that have passed verification on the production conditions and processes,determining whether site inspection and inspection contents shall be carried out, so as to avoid repeated inspection.

Article 50 When the CMDE of NMPA conducts technical review on imported Class II and Class III IVD reagents, if it considers it is necessary to carry out quality management system verification, it shall notify the Inspection Center of NMPA to carry out verification according to relevant requirements.

Section IV Product Registration

Article 51 After completing the study on the safety and effectiveness of IVD reagents supporting the registration, and making preparations for the verification of the quality management system, the applicant shall apply for the registration of IVD reagents, and submit the application materials to the drug supervision and administration department through online registration application paths according to relevant requirements:

(I) Data for product risk analysis;

(II) Technical requirements for products;

(III) Product inspection report;

(IV) Clinical evaluation data;

(V) Product instructions and sample labels;

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

(VII) Other necessary documents to demonstrate the safety and effectiveness of the products.

Article 52 The drug supervision and administration department shall conduct review on application dossiers after accepting an application, and handle respectively according to the following circumstances:

(I) The application items are within the scope of the administrative authority with complete application dossiers and in conformity with the formal review, the application shall be accepted;

(II) If there are errors in the application dossiers that can be corrected on the spot, the applicant is allowed to make rectification on the spot;

(III) If the application dossiers are incomplete or do not comply with the legal form, the applicant shall be informed of all contents to be supplemented or corrected in one time on site or within 5 working days; if failing to inform the applicant within the specified time, the application materials shall be accepted from the receipt date;

(IV) If the application items don't fail within the scope of the administrative authority, the decision of not to accept the application shall be made immediately, and the applicant shall be notified to apply to the relevant administrative authority.

The drug supervision and administration department shall issue a notice of acceptance or a notice of denial with special stamp of the authority and dated, depending on whether the IVD reagents registration application is accepted or not.

After the application for registration of IVD reagents is accepted, if the applicant needs to pay the fees, the applicant shall pay the fees according to the regulations. If the applicant fails to pay the fee within the specified time limit, it shall be deemed that the applicant voluntarily withdraws the application, and the drug supervision and administration department shall terminate its registration procedure.

Article 53 If supplementary documents are required during technical review, the technical review institution shall notify all the contents that need to be supplemented and corrected at one time. The applicant shall, within one year after receiving the supplement and correction notice, provide supplementary materials once in accordance with the requirements of the notice of correction, and the technical review institution shall complete the technical review within the prescribed time limit after receiving the supplementary materials.

If the applicant has objections to the content of supplement and correction notice, it may give its opinion in writing to the corresponding technical review institution, along with rationales and corresponding technical supporting data.

If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated, and the drug supervision and administration department shall make a decision of not registering.

Article 54 For an accepted registration application, the applicant may, before making the decision on administrative license, apply to the drug supervision and administration department that accepted the application for withdrawal of the registration application and relevant materials, and explain the reasons. If it agrees to withdraw the application, the drug supervision and administration department shall terminate its registration procedure.

If, in the process of review, verification and review and approval, it is found that there are suspected illegal acts such as concealing the true situation or providing false information, they shall be dealt with according to law, and the applicant shall not withdraw the application for registration.

Article 55 For an accepted registration application, if there is evidence that the registration application dossiers may be false, the drug supervision and administration department may suspend the review and approval. It will be decided whether it shall be further reviewed or the registration application shall be denied after verification.

Article 56 During the review of the application for registration of IVD reagents, the technical review institution shall inform the applicant of the reasons for rejection, and the applicant may raise objections to the technical review institution within 15 days, and the contents of objections are limited to the original application items and original application materials. The technical review institution shall conduct comprehensive evaluation and feedback to the applicant based on the applicant's objections. The objection processing time is not included in the review time limit.

Article 57 The drug supervision and administration department accepting the registration application shall make a decision on whether to approve it after the technical review is completed. IVD reagents that meet the requirements of safety, effectiveness and controllability in quality shall be approved for registration and issued with the Medical Device Registration Certificate, and the approved product technical requirements and product instructions will be distributed to the applicant in the form of attachment. For the products that are not approved for registration, the reasons shall be given in writing, and the applicant shall be informed of its right of applying for administrative reconsideration or appealing to administrative proceeding by law.

The validity period of the Registration Certificate for Medical Device is five years.

Article 58 For accepted registration application, in case of any of the following circumstances, the drug supervision and administration department shall make a decision not to register and inform the applicant:

(I) The applicant cannot, through study and its findings, prove the safety, effectiveness and controllability in quality of the IVD reagent proposed for marketing;

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

(III) The registration application dossiers are false;

(IV) The contents of the registration application dossiers are confusing, contradictory, or obviously inconsistent with the application items, and the product can not be proved to be safe, effective and controllable in quality;

(V) Other circumstances under which the registration application shall not be approved.

Article 59 The drug supervision and administration department shall announce to the public and hold a hearing on the matters that shall be heard for the implementation of administrative license according to laws, regulations and rules, or other major administrative license matters involving public interests that the drug supervision and administration department deems necessary. If the application for medical devices registration directly involves a significant interest relationship between the applicant and others, the drug supervision and administration department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative license decision.

Article 60 For urgently needed IVD reagents for treatment of rare diseases, diseases which are seriously life-threatening and have no effective treatment means, and those used for coping with public health emergencies, the drug supervision and administration department may make a conditional approval decision, specifying the validity period, the study that needs to be completed after marketing, the completion time limit and other related matters in the Medical Device Registration Certificate.

Article 61 For conditionally approved IVD reagents, the registrant shall collect data on benefits and risks after the IVD reagents are marketed, continuously monitor and evaluate the benefits and risks of the applied products, take effective measures to actively control risks, and complete relevant study and apply within the prescribed time limit as required.

Article 62 For conditionally approved IVD reagents, if the registrant fails to complete the study as required within the time limit or cannot prove that the benefits outweigh the risks, the registrant shall apply for cancellation of the Medical Device Registration Certificate in time, and the drug supervision and administration department may cancel the Medical Device Registration Certificate according to law.

Article 63 For a newly researched and developed IVD reagent not yet listed in the classification catalogue of IVD reagents, the applicant may directly apply for a Class III IVD reagent registration, determine the product category in accordance with the Classification Rules and apply to the NMPA for classification and definition.

Where a Class III IVD reagent registration is directly applied for, the NMPA shall determine the class based on its risk degree. For the domestic IVD reagents identified as Class II or Class I, the applicant shall be informed to apply for registration or filing with the corresponding drug supervision and administration department.

Article 64 Where, for a registered IVD reagent, whose management category is adjusted from a higher category to a lower category, the registration certificate within its period of validity shall remain valid. If renewal is needed, the registrants shall apply for renewal of registration or filing to the corresponding drug supervision and administration department six months before the expiration of the Medical Device Registration Certificate in accordance with the adjusted category.

For registered IVD reagents adjusted from a lower management category to a higher category, the registrant shall submit registration application to the corresponding drug supervision and administration department in accordance with the adjusted category. The NMPA shall stipulate the time limit for completing the adjustment in the notice of adjustment of the management category.

Article 65 If the Medical Device Registration Certificate is lost, the applicant shall apply for reissuance to the original certificate issuing authority; the original certificate issuing authority will reissue the Medical Device Registration Certificate after verification.

Article 66 Where a patent dispute arises during the registration review or after approval, it shall be dealt with according to relevant laws and regulations.


CHAPTER 4 Special Registration Procedures

Section I Registration procedures for innovative products

Article 67 For IVD reagents that meet the following requirements, the applicant may apply for the application of innovative product registration procedures:

(I) The applicant legally owns the patent for invention of core technology of the product through its dominant technical innovation activities in China, or obtains the patent for innovation in China or the right of use through legal transfer; and the time for applying for the registration procedure of innovative products shall be within 5 years from the date of patent authorization announcement; or the application of the patent for invention of the core technology has been made public by the patent administrative authority of the State Council.The Patent Searching and Consulting Center of the China National Intellectual Property Administration shall issue a search report indicating that the core technical scheme of the product has novelty and creativity;

(II) The applicant has completed the preliminary study on the product and the product is basically finalized, the study process is true and controlled, and the study data is complete and traceable;

(III) The main working principle/action mechanism of a product is the first of its kind in China, the product performance or safety has radical improvement compared with similar products, the product is in the international leading level technically, and has significant value in clinical application.

Article 68 When apply for applicable innovative product registration procedures, the applicant shall submit an application for reviewing of innovative medical devices to the NMPA after the product is basically finalized. The NMPA shall organize experts to review, and those that meet the requirements shall be included in the registration procedure of innovative products.

Article 69 For the application for registration of IVD reagents applicable to innovative product registration procedures, the NMPA and the institutions undertaking relevant technical work shall designate special personnel to be responsible for timely communication and provide guidance according to their respective duties.

For IVD reagents included in the innovative product registration procedures, the CMDE of NMPA can communicate with the applicant on major technical issues, major security issues, clinical trial protocols, summary and evaluation of staged clinical trial results before accepting the application for registration and during the technical review process.

Article 70 If the IVD reagents included in the innovative product registration procedures are voluntarily requested to be terminated by the applicant or the NMPA finds that they no longer meet the requirements of the innovative product registration procedure, the NMPA may terminate the innovative product registration procedure of related products and inform the applicant.

Article 71 IVD reagents included in the innovative product registration procedure are not applicable to the innovative product registration procedure if the applicant fails to apply for registration within the prescribed time limit.

Section II Priority Registration Procedures

Article 72 For IVD reagents that meet one of the following conditions, priority registration procedures may be applied for:

(I) Diagnose rare diseases and malignant tumors with obvious clinical advantages, diagnose unique and multiple diseases of the elderly and there is no effective diagnostic means at present, which is specially used for children and has obvious clinical advantages, or urgently needed clinically and there is no medical device approved for registration of the same variety of products in China;

(II) Medical devices that have been listed in the National Science and Technology Major Project or National Key Research and Development Project;

(III) Other medical devices subject to priority registration procedures as stipulated by the NMPA.

Article 73 To apply for the priority registration procedure, the applicant shall, when applying for the registration of IVD reagents, submit an application for the priority registration procedure to the NMPA. Under the circumstances of Paragraph 1 of Article 72, the NMPA shall organize experts to conduct examination, and those that meet the requirements shall be included in the priority registration procedure; under the circumstances of Paragraph 2 of Article 72, it shall be reviewed by the CMDE of NMPA, and those that meet the requirements shall be included in the priority registration procedure; under the circumstances of Paragraph 3 of Article 72, the NMPA shall listen to opinions extensively and organize experts to demonstrate whether to include them in the priority registration procedure.

Article 74 The NMPA shall give priority to the review and approval of the application for registration of IVD reagents included in the priority registration procedure, and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall give priority to the verification of the registration quality management system.

During the technical review of medical device products included in the priority registration procedure, the CMDE shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary.

Section III Emergency Registration Procedures

Article 75 The drug supervision and administration department may, in accordance with the law, implement emergency registration for IVD reagents that are required for public health emergencies and have no similar products marketed in China, or that similar products have been marketed but whose supply cannot meet the needs for emergency treatment of public health emergencies.

Article 76 When applying for applicable emergency registration procedures, the applicant shall apply to the NMPA for emergency registration and application. Those meeting the conditions shall be included into the emergency registration procedures.

Article 77 The NMPA shall immediately handle the application for registration of IVD reagents for emergency registration in accordance with the principles of unified command, early intervention, on-call review and scientific review and approval, and carry out IVD reagents product inspection, system verification and technical review in parallel.


CHAPTER 5 Change and Renewal of Registration

Section I Change of Registration

Article 78 The registrant shall take the initiative to carry out post-marketing research on IVD reagents, further confirm the safety, effectiveness and quality controllability of IVD reagents, and strengthen the continuous management of listed IVD reagents.

For substantive changes in the design, raw materials, production process, scope of application and method of use of the registered Class II and Class III medical devices that may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for change of registration. Other changes shall be filed to the original registration department within 30 days after the changes.

The product name, packing specifications, main components, intended use, product technical requirements, product instructions, production address of imported IVD reagents, etc. stated in the registration certificate belong to the matters that subject to change of registration as specified in the preceding paragraph. The name and domicile of the registrant and the name and domicile of the agent belong to the matters that need to be filed as specified in the preceding paragraph. If the production address of IVD reagents in China is changed, the registrant shall handle the filing procedures 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 systems and report to the drug supervision and administration department in accordance with the regulations.

Article 79 Substantial changes in the core technical principles of registered Class II and Class III IVD reagents, or other major changes that have a significant impact on the safety and effectiveness of products and essentially constitute new products, are not belong to the change application items stipulated in this Chapter, and shall be handled in accordance with the provisions of the registration application.

Article 80 For change of registration application, the technical review institution shall focus on the changed part, and evaluate the safety, effectiveness and controllability in quality of the products after change to form an review opinion.

Where the drug supervision and administration department deems that it is necessary to inspect the quality management system during the technical review of the application for change registration, it shall organize an inspection on the quality management system.

Article 81 Medical device registration change document shall be used together with the original Medical Device Registration Certificate, and the expiration date of the validity period is the same as the original Medical Device Registration Certificate.


Section II Renewal of Registration

Article 82 If the Medical Device Registration Certificate is for renewal upon validity period, the applicant shall apply for registration renewal to the original registration department 6 months before the validity period of the Medical Device Registration Certificate, together with the application dossiers in accordance with the relevant requirements.

Except the situation stipulated in Article 83 in this Measures, the drug supervision and administration department, upon receipt the application for registration renewal, shall make decision on registration renewal prior to the validity period of the Medical Device Registration Certificate. If no decision is available after the due time, the renewal application shall be deemed having been approved.

Article 83 The registration renewal shall not be approved in any of the following circumstances:

(I) The applicant fails to apply for registration renewal within the specified time limit;

(II) The new mandatory standards for IVD reagents or national standards are issued and implemented, and the IVD reagents applied for renewal of registration cannot meet the new requirements;

(III) For the IVD reagents with conditional approval, the items specified in the Medical Device Registration Certificate are not completed within the specified time limit.

Article 84 If the approval time of renewal registration is within the validity period of the original registration certificate, the starting date of the validity period of the renewal registration certificate shall be the next 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 registration certificate for renewal registration shall be the date of approval of renewal registration.

Article 85 If the acceptance, review and approval procedures of application for change or renewal of IVD reagents registration are not stipulated in this chapter, it shall be referred to relevant provisions in Chapter III of this Measures.


CHAPTER 6 Filing of IVD Reagents

Article 86 Filing for a Class I IVD reagent shall be conducted prior to production.

Article 87 For the filing of IVD reagents, the filling registrant shall submit the filing information to the drug supervision and administration department in accordance with the Regulations for the Supervision and Administration of Medical Devices and obtain the filing number.

Article 88 For a filed IVD reagent, where the contents set forth in the filing information form for IVD reagent changed, the filing registrant shall submit a description of the change and related supporting documents to the original filing department and apply for change of filing. The drug supervision and administration department shall publish the changes in the record information.

Article 89 If the management category of the registered IVD reagents is adjusted to the Class II or Class III IVD reagents, it shall apply for registration in accordance with the provisions of this Measures.


CHAPTER 7 Working Time Limit

Article 90 The time limit stipulated in this Measures is the longest time for the acceptance, technical review, verification and review and approval of IVD reagents registration. The working time limit related to the special registration procedures shall be implemented according to the relevant provisions of the special registration procedures.

The CMDE and other professional technical institutions shall specify and publish their respective working procedures and time limit to the public.

Article 91 After receiving the application for registration of IVD reagents, the drug supervision and administration department shall transmit the application materials to the technical review institution within 3 days from the date of acceptance.

Article 92 The time limit for technical review of IVD reagent registration shall be implemented in accordance with the following provisions:

(I) The time limit for technical review of the application for registration, change of registration and renewal of registration of Class II IVD reagents is 60 days, and the time limit for technical review after supplementation and correction of application materials is 60 days;

(II) The time limit for technical review of the application for registration, change of registration and renewal of registration of Class III IVD reagents is 90 days, and the time limit for technical review after supplementation and correction of application materials is 60 days.

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

(I) The CMDE of NMPA shall notify the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government to start the verification within 10 days after accepting the application for IVD reagents registration;

(II) The drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government shall, in principle, complete the verification within 30 days after receiving the verification notice, and feed back the verification information, verification results and other related materials to the CMDE.

Article 94 The drug supervision and administration department accepting the application for registration shall make decisions within 20 working days from the dates when the review opinions are received.

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

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 extended time limit shall not exceed 1/2 of the original time limit. After being approved by the person in charge of relevant technical institutions such as medical device technical review and verification, the technical institution that extended the time limit shall inform the applicant in writing and inform other relevant technical institutions.

Article 97 The original license issuing authority shall reissue the Medical Device Registration Certificate within 20 days after receiving the application for re-issuance.

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

(I) The time taken by the applicant for supplementary materials and rectification after verification;

(II) Time for delaying the verification due to the applicant;

(III) The time when external expert consultation is needed, the expert consultation meeting is held, and joint review with the drug review institution;

(IV) If the review and approval procedures are suspended in accordance with regulations, the time taken during the suspension of the review and approval procedures;

(V) The time taken for quality management systems verification.

Article 99 The time limit stipulated in this Measures shall be calculated on working days.


CHAPTER 8 Supervision and administration

Article 100 The drug supervision and administration department shall strengthen the supervision and inspection of the research and development activities of IVD reagents, and when necessary, it may conduct extended inspections on units and individuals that provide products or services for the research and development of IVD reagents. Relevant units and individuals shall cooperate and provide relevant documents and materials, and shall not refuse, conceal or obstruct them.

Article 101 The NMPA shall establish a step-by-step implementation system for the unique device identification (UDI), applicants and filing applicants shall submit UDI related information in accordance with relevant regulations, so as to ensure that the data is true, accurate and traceable.

Article 102 The NMPA shall timely inform the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government of the agent's information. The drug supervision and administration department of the provinces, autonomous regions or municipalities directly under the Central Government shall organize daily supervision and management of agents in their respective administrative regions.

Article 103 The drug supervision and administration department of the provinces, autonomous regions or municipalities directly under the Central Government shall, according to the filing situation of medical device clinical trial institutions, organize the supervision and inspection of clinical trial institutions that have been filed within their respective administrative regions. For newly filed medical device clinical trial institutions, the first supervision and inspection shall be carried out within 60 days after filing.

The drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government shall organize daily supervision and inspection on medical device clinical trial institutions in this administrative region in compliance with Good Clinical Practice for Medical Practice, and supervise them to continuously meet the prescribed requirements. The NMPA shall supervise and inspect the clinical trial institutions of medical devices as required.

Article 104 If the drug supervision and administration department deems it necessary, the authenticity, accuracy, integrity, standardization and traceability of clinical trials can be checked on site.

Article 105 If the drug supervision and administration department undertaking the filing of Class I IVD reagent products finds that the filing information are not standardized during the post-filing supervision, it shall order the filling registrant to make corrections within a time limit.

Article 106 If the drug supervision and administration department fails to discover the systemic and regional risks in the registration management of IVD reagents within its administrative area in time, or fails to eliminate the systemic and regional hidden dangers in the registration management of IVD reagents within its administrative area in time, the drug supervision and administration department at a higher level may conduct questioning to the drug supervision and administration department at a lower level.


CHAPTER 9 Legal Liabilities

Article 107 Those who violate the provisions of Article 78 of this Measures and fail to record the changes in accordance with the requirements shall be ordered to make corrections within a time limit; those who fail to make corrections within the time limit shall be subject to a fine of RMB 10,000 to 30,000.

Article 108 Those who fail to comply with the Good Clinical Practice when carrying out clinical trials of IVD reagents shall be punished in accordance with Article 94 of the Regulations for the Supervision and Administration of Medical Devices.

Article 109 Where a technical review institution for medical devices fails to perform its duties in accordance with this Measures, resulting in major errors or serious consequences in the review, the departments in charge of drug supervision and administration shall order it to make corrections, report criticisms and give warnings; where serious consequences are caused, the legal representative, principal responsible person, direct responsible person in charge and other responsible persons of the illegal institution shall be given sanctions according to law.

Article 110 Any staff member of the department in charge of drug supervision and administration who, in violation of regulations, abuses his power, neglects his duty or engages in malpractices for personal gain shall be punished according to law.


CHAPTER 10 Supplementary Provisions

Article 111 Naming for IVD reagents shall comply with the following principles:

IVD reagent product name may generally consist of three parts. Part one, name of the tested substance; Part two, function, such as assay kit, quality control product and etc.; Part three, method or principle, such as magnetic particle chemiluminescence immunoassay, fluorescence PCR, fluorescence in situ hybridization, etc., and this part shall be listed in parentheses.

If the analyte has too many components or in case of other special circumstances, name of indications related to the product or other alternative name may be used.

Class I products, calibration and quality control products shall be named according to their intended use.

Article 112 The registration or filing unit of IVD reagent shall be a single reagent or a single reagent kit. One registration or filing unit may include different packaging sizes.

Calibration and quality control products may apply for registration separately or in conjunction with matching IVD reagents in conjunct use.

Article 113 The IVD reagents approved for registration refer to those consistent with the content limited in the Medical Device Registration Certificate and attachments thereof and are manufactured within the validity period of the Medical Device Registration Certificate.

Article 114 The independent reagent components specified in the column of "main components" in the Medical Device Registration Certificate can be sold separately if they are used in the original registered product.

Article 115 The applicant can refer to the main document of registered medical device with the authorization of the owner of the main document of medical device when applying for the registration and change of IVD reagent products. The main documents of medical devices shall be registered by their owners or agencies, and relevant working procedures shall be stipulated separately.

Article 116 The format of Medical Device Registration Certificate shall be normalized by NMPA uniformly.

Registration numbers shall be arranged in the following form:

×1 XZ ×2××××3×4××5××××6, wherein:

×1 shall mean the abbreviation of the place where the registration review and approval authority is located:

The item "G"(Guo) shall be adopted for domestic Class III IVD reagents, imported Class II and Class III IVD reagents;

The domestic Class II of IVD regents is the abbreviation of the province, autonomous region and municipality directly under the Central Government where the registration review and approval department is located;

×2 shall indicate the form of registration:

"Z"(Zhun) is applicable to domestic IVD reagents;

"J"(Jin) is applicable to import IVD reagents;

"X"(Xu) is applicable to IVD reagents from Taiwan, Hong Kong and Macao;

××××3 shall indicate the year of initial registration;

×4 shall the product management category;

××5 shall indicate the product classification code;

××××6 shall indicate the serial number of initial registration.

For the registration renewal, ××××3 and ××××6 shall remain the same. If the management category is adjusted, a new number shall be assigned.

Article 117 The Filing Certificate for Class I Medical Device shall be arranged in the following form:

X1 XB XXXX2XXXX3.

with:

X1 shall mean the abbreviation of the place where the filing authority is located:

The item "G"(Guo) shall be adopted for imported Class I IVD reagents;

The abbreviation of the province, autonomous region, or municipality directly under the Central Government where the filing authority is located plus the abbreviation of the administrative area at the level of municipal government with districts shall be adopted for domestic Class I IVD reagents (if there is no corresponding administrative area at the level of municipal government with districts, it shall only be the abbreviation of the province, autonomous region, or municipality directly under the Central Government);

XXXX2 shall indicate the year of filing;

XXXX3 shall indicate the serial number of filing.

Article 118 Electronic documents of Medical Device Registration Certificate, change registration document produced by drug supervision and administration department have the same legal effect as paper documents.

Article 119 The NMPA, may, according to work necessity, authorize the drug supervision and administration departments or technical organizations of provinces, autonomous regions and municipalities directly under the Central Government and relevant social organizations to conduct the specific work in accordance with law..

Article 120 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate special registration procedures for Class II IVD reagents within their respective administrative areas with reference to the provisions of Chapter IV of this Measures, and report them to the NMPA for filing.

Article 121 The charging items and charging criteria applicable for the IVD reagents registration shall follow the applicable provisions stipulated by the finance and pricing departments of the State Council.

Article 122 The relevant provisions on emergency use of IVD reagents shall be separately formulated by the NMPA in conjunction with relevant departments.

Article 123 If there is no product of the same variety on the market in China, the medical institution will research and develop IVD reagents according to the clinical needs of the institution and use the IVD reagents in the institution under the guidance of practicing physicians. The relevant management regulations shall be separately formulated by the NMPA in conjunction with relevant departments.

Article 124 The IVD reagents from Hong Kong, Macao and Taiwan shall be registered and filed by reference to the import medical devices.

Article 125 The Measures shall come into force as of October 1, 2021. On July 30, 2014, the Administrative Measures for the Registration of In-vitro Diagnostic Reagents promulgated by former CFDA Order No.5 shall be abolished at the same time.


No part of this publication can be reproduced or transmitted in any form without the prior written permission of the publisher. Standard Translation (Beijing) reserves all the right for the final interpretation.

 

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