The domestic first-class medical device registration (re-registration) consists of acceptance and administrative approval. The total time limit for approval is 30 working days from the date of issuance of the acceptance notice.

  I. Acceptance   Mainly conduct formal review of the application materials for domestic first-class 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 first-class medical device registration (re-registration) shall submit the prescribed registration application materials to the drug supervision and administration department of the city divided into districts (food) where they are located.

   (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 for Medical Device Manufacturing Enterprises   The qualification certificate includes a copy of the "Class I Medical Device Manufacturing Enterprise Registration Form" and a copy of the copy of the "Business License for Industry and Commerce".

   (1) The products applied for registration (re-registration) shall be within the scope of production approved in the "Registration Form of the First Class Medical Device Manufacturers";

   (2) The Industrial and Commercial Business License is 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 full performance test report   The product full performance test report should include the following:

   (1) Product name, specification model, product number or batch number, production date, number of samples, sampling base;

   (2) Test basis, test items, standard requirements, test results, result judgment, signature or seal of inspectors and auditors, inspection date, etc.;

   (3) If it belongs to the entrusted inspection, the inspection report and the entrusted inspection agreement issued by the entrusted testing agency shall be provided.

  5. Description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise

  The description of the existing resource conditions and quality management capabilities (including testing methods) of the enterprise's product production should include the following:

   (1) A description of the existing resources (human resources, infrastructure, working environment, etc.) conditions, management capabilities, production capabilities, inspection methods and capabilities of the applicant enterprise;

   (2) Provide a list of production equipment, testing instruments, and valid verification certificates (photocopies) of measuring instruments required for product inspection.

  6. Instructions for medical devices   Instructions for medical devices should at least include the following:

  (1) Product name, model and specification;

  (2) The name, registered address, production address and contact information of the manufacturer;

   (3) The number of the "Medical Device Manufacturing Enterprise License", the number of the medical device registration certificate (the content is blank when applying), and the product standard number;

  (4) Product performance, main structure and scope of application.

  7. Product quality tracking report (applicable to re-registration)

  Product quality tracking report should include the following:

   (1) The company's quality control measures for products and the description of the review of product quality in the internal audit;

  (2) User feedback on product quality during product use;

   (3) Product quality in periodic inspection of products and daily ex-factory inspection; product quality supervision and random inspection by (food) drug supervision and administration departments at or above the provincial level;

   (4) The enterprise implements the adverse event monitoring system and the monitoring of adverse events;

  (5) Information about product quality collected by the enterprise, statistical analysis, measures taken and verification, etc.

  8. Original medical device registration certificate (applicable to re-registration)

(1) If it falls under Article 33 of Chapter V of the "Administrative Measures for Medical Device Registration", a copy of the original medical device registration certificate should be submitted; (2) If it falls under Article 34 of Chapter V of the "Measures for the Administration of Medical Device Registration" Article 35, the original medical device registration certificate shall be submitted.

  9. Self-Guaranteed Statement of Authenticity of Submitted Materials

  The self-assurance statement of authenticity shall be signed by the legal representative or person in charge of the applicant enterprise and stamped with the official seal of the enterprise, and include the following contents:  (1) List of submitted application materials;

   (2) The production enterprise undertakes to undertake corresponding legal responsibilities.

  10. Format requirements for application materials

  (1) The filling of the same item in the application materials should be consistent;

   (2) The application materials should be printed on A4 size paper, and the documents issued by the government and other institutions should be provided in the original size;

   (3) The application materials should be clear and tidy, each application material should be stamped with the official seal of the enterprise, and bound into a booklet according to the order of the application material catalog.

  (2) The person in charge of this position   is the medical device registration acceptance personnel of the district/city (food) drug administration department.

  (3) Responsibilities and Authority

1. If the product applied for registration by the applicant enterprise does not fall within the scope of the authority of the department according to the law, it shall immediately make a decision not to accept it, issue a "Notice of Rejection" affixed with the special seal of the department and indicate the date, and inform the application apply to the relevant administrative agency.

2. If the product applied for registration by the applicant enterprise falls within the scope of the authority of the department, it shall review the application materials of the production enterprise according to the acceptance requirements, and issue an acceptance opinion on the spot or within 5 working days. It is accepted from now on.

  (1) For those who meet the acceptance requirements, the "Notice of Acceptance" with the special seal of the department and the date should be issued, and the "Medical Device Product Registration Review Record" should be filled out;

   (2) For those who do not meet the acceptance requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected at one time, and a "Notice of Supplementation and Correction of Materials" shall be issued.

  3. For the "Notice of Supplementary Materials" issued during the administrative examination and approval process, all supplementary materials shall be collected according to the requirements of the notification.

  4. Complete the document entry within 2 working days from the date of issuance of the acceptance notice, and transfer the application materials to the administrative approval link.

  5. Within 10 working days from the date of making the administrative approval decision, inform the applicant company of the result of the registration process for the product it applies for registration. (Not included in the approval time limit)

  (1) If the registration is approved after review and compliance with the regulations, inform the applicant enterprise to obtain the medical device registration certificate with the "Notice of Acceptance";

   (2) If the registration is not approved after review, the certificate will not be issued, and the applicant will be informed in writing of the reasons for the refusal of registration, the relevant rights and complaint channels of the applicant.

  6. After the approval work is over, the application materials, documents formed during the approval process, and review records shall be filed as required.

  2. Administrative examination and approval   Mainly conduct substantive review of the application materials for domestic Class I medical device registration (re-registration), put forward conclusive opinions, and determine that the safety and effectiveness of the registered products are guaranteed and controlled. Responsible for the results of approval or disapproval of registration.  (1) Review

  1. Audit requirements

  (1) Applicable product standards and descriptions

  ①If the registered product standard is adopted as the product standard, the registered product standard text and preparation instructions shall comply with the corresponding provisions of the "Administrative Measures for Medical Device Standards". The main points of the review include: - Whether it complies with the relevant currently valid mandatory national standards, industry standards and relevant laws and regulations; - Whether the standard text complies with the "Regulations for the Compilation of Product Standards for Medical Device Registration" and related regulations; - The main safety of the product , Whether the effectiveness index has been included in the registered product standard; - Whether the intended use of the product has been clarified.

  ②If the national standard or industry standard is adopted as the product standard, the submitted description shall comply with the corresponding provisions of the "Administrative Measures for Medical Device Standards". The main points of the review include: ——whether the quality responsibilities that should be assumed after the product is listed in the description is clear; ——whether the specifications and models of the product are clearly divided in the description; ——whether the submitted national standards and industry standards are the latest version .

  (2) Instructions for medical devices    shall comply with the corresponding regulations of the "Administrative Regulations on Instructions, Labels and Packaging Marks of Medical Devices". Review points include:

  ①According to the "Administrative Regulations on Medical Device Instructions, Labels and Packaging Marks", review the contents that must be included and cannot be expressed in the instructions of medical devices, such as whether there are prohibited contents, and whether there are contents that must be clarified and missing;

  ②According to the relevant technical documents (product standards, test reports, etc.), confirm the main performance, structure, scope of application, contraindications and other contents of the product in the manual.

  (3) Product full performance test report   The review of the product full performance test report shall be based on the content of the description of the product standards and the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise. Review points include:

  ① Whether the test items and results in the test report meet the product standard requirements, and whether the inspection rules are carried out in accordance with the product standard requirements;

  ②Whether the existing resource conditions of the production enterprise are capable of completing the testing of the full performance of the product, in the case of entrusted testing, it shall be checked whether the production enterprise and the entrusted testing party have signed a legally binding entrusted testing agreement within the validity period.

   (4) Description of existing resource conditions and quality management capabilities (including testing methods) When reviewing the descriptions of existing resource conditions and quality management capabilities (including testing methods) of the enterprise, the content of product standards should be combined.

   Through the review of the description, it can be confirmed that the manufacturer has the production capacity and quality assurance capacity of the product.

  (5) Product Quality Tracking Report   By reviewing the product quality tracking report, it can be confirmed that the quality of the registered product is under control, and the safety and effectiveness of the product have no major problems in use.

  2. The person responsible for this post is the medical device registration handler of the district/city (food) drug administration department.

  3. Job responsibilities and authority

  (1) For those who agree with the review requirements, fill in the "Medical Device Product Registration Review Record", and submit the application materials and review records to the reviewers;

   (2) Issue audit opinions for application materials that do not meet the audit requirements, and fill in the "Notice of Supplementary Materials" if supplementary materials are required. After communicating with the reviewers and exchanging opinions, return the application materials and the "Notice of Supplementary Materials" according to the original channels;

   (3) For supplementary materials required by the "Notice of Supplementary Materials", it shall check whether the supplemented materials meet the review requirements, and submit the application materials and review records to the reviewers after the review;

  (4) For the application materials that are not to be approved for registration, write down the questions and opinions in the review record and submit it to the reviewer.

  (2) Review

  1. Review requirements

  (1) Review the audit opinions issued by the manager;

   (2) It is determined that the product applied for registration this time falls within the scope of the department's approval authority, and the approval process conforms to the relevant national policies and regulations and the relevant registration procedures.

  2. Person in charge of this position

   The person in charge of the relevant functional departments of the district/city (food) and drug administration.

  3. Job responsibilities and authority

  (1) For those who meet the review requirements, fill in the "Medical Device Product Registration Review Record", and submit the application materials and review records to the reviewers;

   (2) If there is any objection to the review opinion, the review opinion shall be specified, and the Supplementary Material Notice shall be filled out if supplementary materials are required. After communicating with the reviewers and exchanging opinions, return the application materials and the "Notice of Supplementary Materials" according to the original channel;

  (3) For the application materials that are not to be approved for registration, the questions and comments shall be written in the examination records and submitted to the examiners.

  (3) Approval

  1. Approval requirements

  (1) Review the review opinions issued by the reviewers;

  (2) The products approved for this application for registration are allowed to be registered.

  2. The person in charge of this post is the competent leader of the district/city (food) drug administration.

  3. Job responsibilities and authority

  (1) For those who meet the approval requirements, fill in the "Medical Device Product Registration Review Record", and transfer the application materials and review records to the accepting personnel;

   (2) For the application materials that are not approved for registration, the questions and comments shall be written in the examination record and forwarded to the accepting staff.