Initial registration for overseas medical devices that are approved for marketing at abroad

I. Project name: initial registration of imported medical devices

II. Contents of licensing: Initial registration for overseas medical devices that are approved for marketing at abroad.

III. Basis for implementation: "Regulations for Supervision and Administration of Medical Devices", "Provisions for Medical Device Registration"

IV. Fees: No charge

V. Quantity restrictions: No quantity limit for the licensing

VI. List of application documents:
Data number (1) Application form for registration of overseas medical device;
Data number (2) Medical device manufacturer certification;
Data number (3) Copies of the applicant’s business license, and the manufacturers letter of authorization to agents for registration;
Data number (4) Documents proving overseas medical device competent authorities’ approval or admission of entry into the market of the country (region);
Data number (5) Applicable product standards;
Data number (6) Medical device manuals;
Data number (7) Product registration testing report issued by institutions for medical device testing (for Class II, III medical devices);
Data number (8) Medical device clinical trial data;
Data number (9) Product warranty issued by the manufacturers
Data number (10) Manufacturer’s power of attorney designating Chinese agents, the agent's letter of commitment and business license or institutional registration certificate;
Data number (11) letter of entrustment designating after-sale agencies in China, and the agencies’ letter of commitment and qualification documents;
Data number (12) Self-assurance statement of authenticity of the dossiers submitted;

VII. 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 domestic 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.

VIII. Application process diagram:

IX. Approval procedures:
(I) Acceptance:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center according to the requirements of the "Acceptance standards for domestic Class III and overseas medical device registration application dossiers"(SFDA Department of medical device supervision [2005] No. 111). Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.

(II) Review:
Once accepted, Administrative Service Center shall deliver the application dossiers to the Center for Medical Device Evaluation (CMDE) for technical review, which includes product testing and expert review, and shall not exceed 60days. But the time for the applicant’s rectification, which is based upon opinions after expert review, shall not be included in the time frame for licensing.

(III) Licensing decisions:
Upon receipt of the dossiers after CMDE technical review, CFDA shall make a decision for registration within 30 days, and written explanations shall be made for rejection of registration.

(IV) Delivery:
Within 10 days from the date of decision making of administrative examination and approval, CFDA Administrative Service Center shall deliver the decision to the applicants.

X. Commitment time frame:
The administrative licensing decision shall be made within 90 days from the date of acceptance.

XI. Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center

XII. Changes:
If any content listed in medical device registration certificate changes, the certificate holder shall, within 30 days from the date of change, apply for changes procedures or renew of registration.

XIII. License validity and renewal:
Medical device registration certificate is valid for four years. Upon expiry of Medical Device Registration Certificate, if the sales or use of medical devices are still necessary, the manufacturer shall apply for renew of registration within six months before the valid date. If the manufacturer failed to do so, registration testing shall be required for renew of registration.

XIV. Annual inspection or annual review of the license: None

XV. Institutions for inquiries and complaints:
Inquiries: CFDA
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this TIPS counts on working days, excluding legal holidays