The first registration of domestic third-class medical devices

  I. Project Name: Registration of Domestic Medical Devices

  II. License content: first registration of domestic Class III medical devices

  3. Legal basis for setting and implementing the license:

   Articles 8 and 12 of "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Administration of Medical Device Registration"

  4. Charges: No charge.

  V. Quantity Restriction: There is no quantity restriction on this license item.

   VI. Catalogue of materials submitted by applicants:

  Data No. 1. Application form for domestic medical device registration;

   Document No. 2. Qualification certificate of medical device manufacturing enterprise;

  Data No. 3. Product technical report;

  Data No. 4. Security risk analysis report;

  Data No. 5, applicable product standards and instructions (two copies);

  Data No. 6. Product performance self-test report;

  Data No. 7. Product registration test report issued by medical device testing institutions;

   Data No. 8. Clinical trial data of medical devices;

  Data No. 9, Instructions for Medical Devices;

  Data No. 10. Effective certification documents for product production quality system assessment (certification) - according to the requirements for different products, provide corresponding quality system assessment reports;

  Material No. 11. Self-Guarantee Statement of the Authenticity of the Submitted Materials.

   7. Requirements for application materials:

   (1) General requirements for application materials:

  1. The first page of the application materials is the list of application materials items, and the application materials items in the directory are arranged in the order of Annex 3 of the "Administrative Measures for Medical Device Registration". A cover page shall be added to each item of information, and the product name and the applicant's name shall be indicated on the cover page, and the name of the item of information shall be indicated in the upper right corner. Clear distinguishing marks shall be used between various materials, and the name of each material or the serial number in the catalog where the material is located shall be marked. The entire set of information should be bound into a booklet.

  2. The application materials are in one copy. The application materials should be printed on A4 size paper. The content is complete, clear, and must not be altered. The documents issued by the government and other institutions are provided in the original size.

  3. Copies of application materials should be clear.

  4. The product name in each (marketing approval document, standard, test report, instruction manual) application materials should correspond to the substantive content of the product name filled in the application form. If there is a product name, it should be marked with the product name. The application materials shall be in Chinese, and the original text shall be provided at the same time for the application materials translated according to the foreign language materials.

  5. After the application materials are accepted, the enterprise shall not make a supplementary application by itself, but if it falls under the circumstances specified in Article 38 of the "Administrative Measures for Medical Device Registration", it can make a supplementary application.

   (2) Specific requirements for application materials:

  1. Application form for medical device registration

  (1) The application form for medical device registration can be downloaded from www.sfda.gov.cn;

  (2) The medical device registration application form is one of the important documents for registration application, and the items in the form should meet the requirements for filling out instructions.

  2. Qualification certificate of medical device manufacturing enterprise

   (1) Copies of the copy of the production enterprise license and the copy of the business license, and stamped with the official seal of the enterprise to which the certificate belongs;

   (2) The applied product should be within the production scope approved by the production enterprise license;

  (3) within the validity period.

  3. Product technical report

   should be stamped with the official seal of the manufacturer.

  4. Security risk analysis report

   should be stamped with the official seal of the manufacturer.

  5, product standard

  (1) The standard text shall be stamped with the official seal of the manufacturer;

  (2) Preparation instructions (applicable to registered product standards);

   (3) The declared product should be included in the scope of the product standard;

  (4) Those who adopt national standards and industry standards as applicable standards for products:

  ①The production enterprise shall provide a statement that the applied product complies with national standards and industry standards, and affix the official seal of the production enterprise;

  ②The statement that the manufacturer assumes the quality responsibility after the product is listed, and stamp the official seal of the manufacturer;

  ③The manufacturer's description of the product model and specification division, and stamped with the official seal of the manufacturer.

  6. Product performance self-test report

  (1) It should be signed by the chief inspector or the person in charge of the chief inspector and reviewer, and stamped with the official seal of the production enterprise;

   (2) For the implementation of national standards and industry standards, the production enterprise shall supplement its own factory inspection items and affix the official seal of the production enterprise.

  7. Test report

   (1) The specifications and models of the inspected products should be within the scope of this registration application;

   (2) The type of testing shall be registered testing or full-performance national supervision and random inspection testing;

  (3) Original;

  (4) Within the validity period (implementation of Article 7 of Annex 3 of the Administrative Measures for Medical Device Registration).

  Note: To implement the provisions of Articles 11, 12 and 13 of the Administrative Measures for Medical Device Registration, the manufacturer shall provide corresponding explanatory documents and affix the official seal of the manufacturer.

  8. Clinical trial data of medical devices

   (1) The manufacturing enterprise shall conduct clinical trials in two or more (including two) "National Drug Clinical Research Bases";

   (2) The clinical trial materials should include the clinical trial contract, clinical trial protocol, and clinical trial report:

  ①The clinical trial contract should be signed and sealed by the medical institution and the implementer undertaking the clinical trial;

  ②Clinical trial protocols should be stamped by the ethics committee, the medical institution undertaking the clinical trial and the implementers;

  ③ The clinical trial report should be signed by the person in charge of the clinical trial and the clinical trial personnel and confirmed by the competent test department.

  9. Instructions for medical devices

  The instruction manual should be provided, and the instruction manual should be stamped with the official seal of the manufacturer; if the instruction manual is omitted, the manufacturer should issue an explanatory document and stamp the official seal of the manufacturer.

  10. Effective certification documents for product production quality system assessment (certification) - according to the requirements of different products, provide corresponding quality system assessment reports

   (1) The signature and seal of the (food) drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government; if it is a medical device quality system certification certificate, a copy can be provided, but the official seal of the enterprise to which the certificate belongs shall be affixed;

  (2) within the validity period;

  (3) The system covers the declared products.

  11. Self-assurance statement for the authenticity of the submitted materials

  (1) List of submitted materials;

   (2) The commitment of the production enterprise to assume legal responsibility;

  (3) The official seal of the production enterprise shall be affixed.

   Nine, licensing procedures:

   (1) Acceptance:

The applicant submits an application to the Administrative Acceptance Service Center, and submits the application materials according to the catalogue listed in Article 6 of this "Instruction". [2005] No. 111) requires formal examination of application materials. If the application matters do not require an administrative license in accordance with the law, the applicant shall be notified immediately that the application is not accepted; if the application matters are not within the scope of the administrative organ's powers according to law, a decision of inadmissibility shall be made immediately, and the applicant shall be informed to apply to the relevant administrative organ; If there are errors in the materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot; if the application materials are incomplete or do not conform to the statutory form, the applicant shall be notified on the spot or within five days of all the contents that need to be corrected. The application materials are accepted from the date of application; the application matters are within the scope of the administrative organ's functions and powers, the application materials are complete and conform to the statutory form, or the applicant submits all supplemented and corrected application materials in accordance with the requirements of the administrative organ, the administrative licensing application shall be accepted.

  (2) Review:

After the    Administrative Acceptance Service Center accepts the application, it will send the application materials to the Medical Device Technical Review Center for technical review. The technical review includes product testing and expert review, and the technical review cannot exceed 60 days. However, after expert review, if rectification opinions are put forward to the applicant, the rectification time of the applicant shall not be included in the permit time limit.

   (3) Licensing decision:

   After receiving the materials from the Medical Device Technical Review Center for the completion of the technical review, the State Food and Drug Administration shall make a decision on whether to grant registration or not within 30 days. If registration is not granted, the reasons shall be explained in writing.

  (4) Delivery:

   Within 10 days from the date of the administrative licensing decision, the SFDA Administrative Acceptance Service Center will deliver the administrative licensing decision to the applicant.

  10. Time limit for commitment: make an administrative licensing decision within 90 days from the date of acceptance.

  11. Implementing organs:

   Implementing agency: State Food and Drug Administration

   Acceptance place: Administrative Acceptance Service Center of State Food and Drug Administration

  12. Changes in matters:

   If the contents listed in the medical device product registration certificate change, the certificate holder shall apply for change procedures or re-registration within 30 days from the date of the change.

  XIII. Validity period and extension of license:

  Medical device product registration certificate is valid for four years. The certificate holder shall apply for re-registration within 6 months before the expiration of the product registration certificate.

  14. License annual review or annual inspection: none

  Note: The working period of this notice is calculated in working days, excluding statutory holidays