Domestic Class II medical device registration (re-registration) consists of acceptance, technical review, and administrative approval. The total time limit for approval is 60 working days from the date of issuance of the acceptance notice.

   1. Acceptance

   Mainly conduct formal review of the application materials for domestic Class II medical device registration (re-registration), ensure the completeness and standardization of the application materials, and announce the acceptance status to the public.

   Medical device manufacturers applying for domestic Class II medical device registration (re-registration) shall submit the prescribed registration application materials to the local provincial (food) drug administration.

   (1) Acceptance requirements

  1. "Domestic Medical Device Registration Application Form"

   The "Application Form for Domestic Medical Device Registration" filled in by the applicant enterprise should be signed by the legal representative and affixed with the official seal. The items filled in should be complete and accurate, and the filled content should meet the following requirements:

  (1) The "name of the manufacturer" and "registered address" are the same as the "Business License for Industry and Commerce";

   (2) "Product name", "specification model" are consistent with the name, specification and model used in the submitted product standards, test reports and other application materials.

  2. Qualification Certificate of Medical Device Manufacturer

   The qualification certificate includes a copy of the copy of the "Medical Device Manufacturing Enterprise License" and a copy of the copy of the "Business License for Industry and Commerce".

   (1) The products for which registration (re-registration) is applied should be within the scope of production approved by the "Medical Device Manufacturing Enterprise License";

   (2) The "Medical Device Manufacturing Enterprise License" and the "Business License for Industry and Commerce" are within the validity period.

  3. Applicable product standards and instructions

   The product standard submitted by the applicant enterprise can be a national standard, an industry standard or a registered product standard text.

   (1) If the national standard or industry standard is adopted as the product standard, the valid text of the adopted national standard or industry standard and the description of the standard selection shall be submitted;

   (2) If the registered product standard is adopted as the product standard, the official text of the registered product standard and its preparation instructions shall be submitted.

  4. Product technical report

  Product technical report should include the following:

  (1) Product features, working principle, structural composition, and intended use;

   (2) The basis for determining product technical indicators or main performance requirements;

  (3) Product design control, development, and development process;

  (4) The main technological process and description of the product;

  (5) Product testing and clinical trials;

  (6) Comparative analysis with similar products at home and abroad.

  5. Security risk analysis report

  The safety risk analysis report should include: energy hazards, biological hazards, environmental hazards, hazards related to use, and hazards caused by functional failure, poor maintenance and aging. Risk analysis, risk control and preventive measures, etc.