List of application documents:
Data number (1) Initial registration form for domestic Class III medical devices;
Data number (2) Medical device manufacturer certification;
Data number (3) Technical Report;
Data number (4) Safety risk analysis report;
Data number (5) Applicable product standards and instructions;
Data number (6) Product performance self-test report;
Data number (7) product registration test report issued by medical device testing institutions;
Data number (8) Medical device clinical trial data;
Data number (9) Medical device manuals;
Data number (10) valid certifying documents for evaluation (certification) of production quality system - quality system evaluation report for specific product should be provided accordingly;
Data number (11) Self-assurance statement of authenticity of the dossiers submitted;
Data number (12) Application dossiers (esp. clinical trial reports) and authenticity verification report of the sample production process.
Requirements for application dossiers:
(I)General requirements for application dossiers:
The first page of the application dossiers shall be a directory of the application items, the order of which shall be arranged as per by Annex III of the "Provisions for Medical Device Registration". Each dossier shall have a cover page indicating the name of the product and the applicant, and the dossier title shall be marked at the upper right corner. The dossiers shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The entire dossiers shall be bound into a book.
The application dossiers shall be in One set and printed on A4 paper, the content shall be complete, clear, and shall not be altered, the documents issued by the Government and other institutions shall be provided in the original size.
Copies of the dossiers should be clear.
The product names in various items (approvals for marketing, standards, test reports, manuals) of applications dossiers shall correspond with the names and substantial contents in the Application form. Trade name (if any) should be marked. The application dossiers shall be in Chinese, and translated dossiers shall be accompanied with the originals.
(II)Specific requirements for application dossiers:
1.Initial registration form for domestic Class III medical devices;
(1)Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
(2)Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
2.Medical device manufacturer certification;
Copies of the Production License and Business License, stamped with the seal of the enterprise;
The applied product should be within the scope circumscribed by the production license;
And within the validity period.
3.Technical Report;
Should be stamped with the official seal of the manufacturer.
4.Safety risk analysis report;
Should be stamped with the official seal of the manufacturer.
5.Applicable product standards and instructions;
Standard text shall be stamped with the official seal of the manufacturer;
Development instructions (applicable to registered product standards);
Product standards and development instructions shall be in duplicate, together with two statements of standards consistency (applicable to registered product standards);
The applied products should be included in the product standard range;
If national and industry standards are employed as applicable product standards:
① The manufacturer shall provide a statement of compliance with national and industry standards, which shall be stamped with the official seal of the manufacturer;
② A statement for bearing full responsibilities of the quality of post-marketed products produced by manufacturer, which shall be stamped with the official seal the manufacturer;
③ A description of product models and specification classifications produced by manufacturer, which shall be stamped with the official seal the manufacturer.
6.Product performance self-test report;
The dossiers shall have the signatures of the major inspector or major inspection head, and the auditor, and stamped with the official seal of the manufacturer;
If national and industry standards are applied to the product, the manufacturer shall supplement the dossiers of customized ex-factory test items, which shall be stamped with the official seal of the manufacturer.
7.Product registration test report issued by medical device testing institutions;
The specifications and models of the tested products should be within the scope of the registration application;
Test type should be registration test or national full-performance sampling test;
Originals;
Should be within the validity period (as per Article 7 in Annex III of the "Provisions for Medical Device Registration").
Note: If the Article 11, 12 and 13 of the "Provisions for Medical Device Registration" are implemented, the manufacturer shall provide appropriate documentation stamped with its official seal.
8.Medical device clinical trial data;
The manufacturer should conduct clinical trials in two or more (including two) "National Drug Clinical Study Site";
The clinical trial data should include clinical trial contracts, clinical trial protocols and clinical trial reports:
① The clinical trial contract should stamped with the seal of medical institutions undertaking the clinical trials and signed by clinical trials implementers;
② Clinical trial protocol shall be sealed by the Ethics Committee, the medical institutions undertaking the clinical trials and implementers;
③ Clinical trial reports should be signed by the person in charge and investigators, sealed and confirmed by the competent authorities.
9.Medical device manuals;
Product manual should be provided and should be stamped with the seal of the manufacturer; the omission of product manual shall be explained by the manufacturer’s specified documents, and stamped with the official seal of the manufacturer.
10.Valid certifying documents for evaluation (certification) of production quality system - quality system evaluation report for specific product should be provided accordingly;
Stamps of the (food) drug administration departments of the Provinces, autonomous regions and municipalities; a copy of medical device quality system certificate (if any) can be submitted, but it should be stamped with the official seal of the holder;
And within the validity period.
Product system shall cover the applied product
11. Self-assurance statement of authenticity of the dossiers submitted;
List of submitted dossiers;
Manufacturers commitment for legal liabilities;
Should be stamped with the official seal of the manufacturer.
12. Application dossiers (esp. clinical trial reports) and authenticity verification report of the sample production process.
During the inspection of quality management system, food and drug administration departments of the Provinces (autonomous regions and municipalities) shall verify the authenticity of the application dossiers for initial registration of Class III medical devices (esp. clinical trial reports), and the authenticity of the production process of the samples. While applying for quality management system evaluation, the manufacturer shall also submit relevant information. If the medical institution undertaking clinical trials is not within the jurisdiction of the food and drug administration department of the manufacturer’s province (autonomous regions or municipalities), the latter can entrust the counterpart department of medical institution’s province (autonomous regions or municipalities) to conduct the review and issue inspection opinions. CFDA shall conduct random checks, if necessary, on the inspection of the authenticity of application dossiers for initial registration of Class III medical devices.
Application process diagram:
