Requirements for application dossiers:
(I) General requirements for application dossiers:
1. 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 VI 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.
2. 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.
3. Copies of the dossiers should be clear.
4. 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. Chinese signature or seal follows the format prescribed in [2004] Doc. No.499.
(II) Specific requirements for application dossiers:
1. Application form for registration of overseas medical device;
(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;
(1) Documents proving eligibility in producing medical devices;
(2) Copies shall be signed and sealed by the original certificate issuers or notarized by the local notary organizations;
(3) within the validity period (if any).
3. Copies of the applicant’s business license, and the manufacturers letter of authorization to agents for registration;
(1) copy of the business license of the applicant
① Copies are permissible but must be stamped by the seals of the certificate holders;
② And within the validity period.
(2) Letter of entrustment for registration
Shall be stamped by the manufacturers.
4. Documents proving overseas medical device competent authorities’ approval or admission of entry into the market of the country (region);
(1) Certifying documents approving the marketing of the medical devices, which is issued by medical device competent authorities in jurisdiction of the overseas applicant’s registered address or the country (region) where the production site is located.
(2) Copies shall be signed and sealed by the original certificate issuers or notarized by the local notary organizations;
(3) within the validity period (if any).
5. Applicable product standards;
(1) normative text；
(2) Development instructions (applicable to registered product standards);
(3) Product standards and development instructions shall be in duplicate, together with two statements of standards consistency (applicable to registered product standards);
(4) The applied products should be included in the product standard range;
(5) 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 undertaking of full responsibilities of the quality of post-marketed products produced by manufacturer, which shall be stamped with the official seal of the manufacturer;
③ A description of product models and specification classifications produced by manufacturer, which shall be stamped with the official seal of the manufacturer.
(6) Registered product standards shall be stamped with the seals of the manufacturers or their Chinese agencies, or the units entrusted by the manufacturers for drafting standards, the letter of entrustment shall indicate that "the manufacturer shall be responsible for product quality", and stamped by the manufacturer.
6. Medical device manuals;
(1) Product manuals should be provided; omission of which shall be accompanied by specifications issued by manufacturers, and stamped by the manufacturer;
(2) The product manuals of Class II and III medical devices should be sealed by the manufacturer or its representative office in China, while Class I medical device manuals can do without seals.
7. Product registration testing report issued by institutions for medical device testing (for Class II, III medical devices);
(1) The specifications and models of the tested products should be within the scope of the registration application;
(2) Test type should be registration test or national full-performance sampling test;
(3) Originals;
(4) Should be within the validity period (as per Article 7 in Annex VI 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 or the seals of its Chinese agencies.
(5) If the Article 15 of the "Provisions for Medical Device Registration" is implemented, the manufacturer shall apply for suspension of test and make related commitments, which shall be stamped with its seals.
8. Medical device clinical trial data;
(1) The demestic clinical trial report shall be provided in accordance with the Annex XII of the "Provisions for Medical Device Registration"
① The manufacturer should conduct clinical trials in two or more (including two) "National Drug Clinical Study Site";
② The clinical trial data should include clinical trial contracts, clinical trial protocols and clinical trial reports:
a. The clinical trial contract should stamped with the seal of medical institutions undertaking the clinical trials and signed by clinical trials implementers;
b. Clinical trial protocol shall be sealed by the Ethics Committee, the medical institutions undertaking the clinical trials and implementers;
c. Clinical trial reports should be signed by the person in charge and investigators, sealed and confirmed by the competent authorities.
(2) In accordance with the Annex XII of the "Provisions for Medical Device Registration", if overseas clinical trial report needs to be submitted, the applicant shall submit the clinical trial data approved by medical device regulatory authorities of overseas governments for the registration and marketing of the product or (similar products), which shall be signed and sealed by the manufacturer or its agency or representative office in China.
9. Product warranty issued issued by the manufacturers
Shall be stamped by the manufacturers.
10. Manufacturer’s power of attorney designating Chinese agents, the agent's letter of commitment and business license or institutional registration certificate;
(1) Agent's letter of entrustment shall be signed and sealed by the manufacturer, and notarized by the notary organization in which country (region) it locates.
(2) Letter of commitment shall be signed and sealed by the agent;
(3) Business license or registration certificate signed and sealed by certificate owner.
11. Letter of entrustment designating after-sale agencies in China, and the agencies’ letter of commitment and qualification documents;
(1) Letter of entrustment for after-sales service signed and sealed by the manufacturer;
(2) Letter of commitment signed and sealed by the agency entrusted;
(3) Qualification documents signed and sealed by certificate-owned enterprises.
12. Self-assurance statement of authenticity of the dossiers submitted;
(1) Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
(2) The Statement should submit a list of dossiers;
(3) Including a commitment to legal liability.
