Optometers belong to the second class of medical devices stipulated in China, and the production needs medical device registration certificate and medical device production license; Sales need medical device management for the record.
Application for registration of medical devices
Article 31 To apply for medical device registration, the applicant shall submit the application materials to the food and drug supervision and administration department as required.
Article 32 After receiving the application, the food and drug supervision and administration department shall examine the application materials in form and deal with them according to the following circumstances:
(a) the application matters belong to the scope of functions and powers of the department, and if the application materials are complete and meet the requirements of formal examination, it shall be accepted;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be informed of all the contents that need to be corrected at one time within five working days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials;
(four) if the application matters do not fall within the scope of authority of the department, it shall immediately inform the applicant that it will not be accepted.
When accepting or rejecting an application for registration of medical devices, the food and drug supervision and administration department shall issue a notice of acceptance or rejection stamped with the special seal of the department and dated.
Article 33 The food and drug supervision and administration department that accepts the application for registration shall, within 3 working days from the date of acceptance, forward the application materials to the technical evaluation institution.
The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days, and complete the technical review of the registration of Class III medical devices within 90 working days.
If external expert review is needed, and the combined products of pharmaceutical machinery need to be jointly reviewed with the drug review agency, the time required shall not be counted, and the technical review agency shall inform the applicant in writing of the time required.
Thirty-fourth food and drug supervision and management departments in the organization of product technical review, can consult the original research data, organize the applicant to check the quality management system related to product development and production.
The verification of the registration quality management system of Class II and Class III medical devices in China is implemented by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and the verification of the registration quality management system of Class III medical devices in China is implemented by the state.
The technical review agency of the General Administration of Food and Drug Administration of the United States informs the food and drug supervision and administration departments of the corresponding provinces, autonomous regions and municipalities directly under the Central Government to carry out verification and participate in verification when necessary. Food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government
According to relevant requirements, system verification should be completed within 30 working days.
When China Food and Drug Administration's technical review body considers it necessary to verify the quality management system when conducting technical review on imported Class II and Class III medical devices, it shall notify China Food and Drug Administration's quality management system inspection technical body to verify in accordance with relevant requirements, and when necessary, the technical review body shall participate in the verification.
The time of quality management system verification is not included in the review time limit.
Thirty-fifth in the process of technical evaluation, the applicant needs to make corrections, and the technical evaluation institution shall inform all the contents that need to be corrected at one time. The applicant shall provide supplementary information at one time in accordance with the requirements of the rectification notice within 1 year; The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the applicant to supplement the information is not counted in the examination time limit.
If the applicant has any objection to the contents of the Notice of Supplementary Information, he may submit written opinions to the corresponding technical review institution, explain the reasons and provide corresponding technical support materials.
If the applicant fails to submit supplementary information within the time limit, the technical review institution shall terminate the technical review, put forward a proposal of not registering, and make a decision of not registering after being approved by the food and drug supervision and administration department.
Article 36 The food and drug supervision and administration department that accepts the application for registration, after technical examination,
Make a decision within 20 working days. Those that meet the requirements of safety and effectiveness shall be registered, and the medical device registration certificate shall be issued within 10 working days from the date of making the approval decision. The approved product technical requirements shall appear in the form of attachments.
Send to the applicant. If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for reconsideration and administrative reconsideration or bring an administrative lawsuit according to law.
The medical device registration certificate is valid for 5 years [2]
Article 37 The registered items of medical devices include licensing items and registered items. The licensing items include product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. ; The registered items include the name and domicile of the registrant, the name and domicile of the agent, and the production address of medical devices in China.
Article 38 When approving the registration of medical devices urgently needed for treating rare diseases and responding to public health emergencies, the food and drug supervision and administration department may require the applicant to further complete relevant work after the product is put on the market, and clearly require it in the medical device registration certificate.
Article 39 The food and drug supervision and administration department shall make a decision not to register the accepted application under any of the following circumstances, and inform the applicant:
(1) The applicant's research on the safety and effectiveness of medical devices to be marketed and its results cannot prove that the products are safe and effective;
(2) The application materials for registration are false;
(3) The contents of the application materials for registration are confusing and contradictory;
(four) the contents of the registration application materials are obviously inconsistent with the application matters;
(5) Other circumstances in which registration is not granted.
Article 40 Before making a decision on administrative license, an applicant who has accepted an application for registration may apply to the food and drug supervision and administration department that accepted the application for registration to withdraw the application for registration and related materials, and explain the reasons.
Article 41 The food and drug supervision and administration department may suspend the examination and approval of an accepted application for registration if there is evidence to prove that the application materials for registration may be false. After verification, continue to review or make a decision not to register according to the verification conclusion.
Article 42 If an applicant refuses to accept the decision of the food and drug administration not to register, he may, within 20 working days from the date of receiving the notice of the decision not to register, file an application for review with the food and drug administration that made the licensing decision. The content of the application for review is limited to the original application items and the original application materials.
Article 43 The food and drug supervision and administration department shall make a review decision within 30 working days from the date of accepting the application for review, and notify the applicant in writing. If the original decision is upheld, the food and drug supervision and administration department will no longer accept the applicant's application for re-examination.
Article 44 If an applicant refuses to accept the decision made by the Food and Drug Administration not to register, and has applied for administrative reconsideration or brought an administrative lawsuit, the Food and Drug Administration will not accept his application for reexamination.
Article 45 If the medical device registration certificate is lost, the registrant shall immediately publish a loss statement in the media designated by the original issuing authority. After 1 month from the date of issuing the loss report, apply to the original issuing authority for a replacement, which will reissue it within 20 working days.
Article 46 Where the application for registration of medical devices directly involves the significant interest relationship between the applicant and others,
The food and drug supervision and administration department shall inform the applicant and interested parties that they can enjoy the right to apply for a hearing in accordance with laws, regulations and other provisions of China Food and Drug Administration; Apply for medical device registration
During the review, if the food and drug supervision and administration department considers it to be a major licensing matter involving public interests, it shall announce it to the public and hold a hearing.
Article 47 For newly developed medical devices that are not listed in the classified catalogue, the applicant may directly apply for product registration of Class III medical devices, or judge the product category according to the classification rules and apply to China Food and Drug Administration for category confirmation before applying for product registration or filing.
Directly applying for the registration of Class III medical devices, China Food and Drug Administration shall determine the category according to the degree of risk. If domestic medical devices belong to Category II, China Food and Drug Administration will forward the application materials.
The food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located shall examine and approve it; If domestic medical devices are classified as Class I, China Food and Drug Administration will transfer the application materials to the municipal level where the applicant is located.
Food and drug supervision and management departments for the record.
Article 48 Patent disputes arising during and after the examination of registration applications shall be handled in accordance with the provisions of relevant laws and regulations.