The optometrist belongs to the second class of medical devices in our country, the production of medical devices need to be registered and medical device production license; sales need to be medical equipment business record.
Application for registration of medical devices
Article 31 To apply for the registration of medical devices, the applicant shall, in accordance with the relevant requirements of the Food and Drug Administration, submit declarations.
Article 32 The food and drug supervision and management department receives the application for formal review of the declaration of information, and in accordance with the following circumstances were dealt with:
(a) the application matters belong to the department's terms of reference, the declaration of information is complete, in line with the requirements of the form of review, to be accepted;
(b) declaration of information that can be corrected on the spot errors, should allow the The applicant on the spot corrections;
(C) the declaration of information is incomplete or does not meet the requirements of the formal review, the applicant should be informed of the need to make corrections within five working days of all the contents of a time, notify the late, since the date of receipt of the declaration of information that is admissible;
(D) the application does not fall within the purview of the department, should be informed of the applicant is not admissible immediately.
Food and Drug Administration acceptance or inadmissibility of applications for registration of medical devices, should be issued with the special seal of the department and the date of acceptance or inadmissibility of the notice.
Article 33 The acceptance of the application for registration of food and drug supervision and management department shall, within three working days from the date of acceptance of the declaration of information forwarded to the technical review body.
Technical review body shall complete the technical review of the registration of Class II medical devices within 60 working days, within 90 working days to complete the technical review of the registration of Class III medical devices.
The need for external expert review, drug and device combination products need to be reviewed jointly with the drug review organization, the time required is not counted, the technical review body shall inform the applicant in writing of the time required.
Article 34 of the Food and Drug Administration in the organization of the technical review of the product can be access to the original research data, and the organization of the applicant for the development of the product, the production of quality management system verification.
Domestic second and third class medical device registration quality management system verification, by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to carry out, in which the third class medical device registration quality management system verification, by the State
Technical review of the State Food and Drug Administration notified the corresponding provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to carry out verification. Participate in the verification when necessary. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration
should be completed within 30 working days in accordance with the relevant requirements of the system verification.
The State Food and Drug Administration technical review body in the import of Class II, Class III medical devices to carry out technical review, that it is necessary to verify the quality management system, notify the State Food and Drug Administration quality management system to check the technical body in accordance with the relevant requirements to carry out the verification, if necessary, the technical review body to participate in the verification.
The quality management system verification time is not calculated in the review time limit.
Article 35 of the technical review process requires the applicant to correct the information, the technical review body shall inform the need to correct all the contents. The applicant shall provide additional information in accordance with the requirements of the notice of correction within one year; the technical review body shall receive additional information from the date of completion of the technical review within 60 working days. The applicant's additional information is not counted in the review time limit.
Applicants have objections to the content of the notice of additional information, you can submit written comments to the appropriate technical review body, explain the reasons and provide the appropriate technical support information.
The applicant fails to submit additional information after the deadline, the technical review organization to terminate the technical review, put forward the recommendation of non-registration, approved by the Food and Drug Administration to make a decision not to register.
Article 36 The food and drug supervision and management department accepting the application for registration shall make a decision within
20 working days after the completion of the technical review. To meet the safety and efficacy requirements, registration is granted, within 10 working days from the date of the approval decision to issue a certificate of registration of medical devices, after approval of the product technical requirements in the form of an attachment
To the applicant. Not registered, shall state the reasons in writing, and at the same time inform the applicant of the right to apply for review and apply for administrative reconsideration or administrative litigation.
Medical device registration certificate is valid for five years[2]
Article 37 of the medical device registration matters, including licensing and registration matters. License matters include product name, model, specifications, structure and composition, scope of application, product technical requirements, imported medical devices, such as the production address; registration matters include the name and residence of the registrant, the name and residence of the agent, the production address of the domestic medical devices.
Article 38 For the treatment of rare diseases and respond to public **** health emergencies urgently needed medical devices, food and drug supervision and management department can approve the registration of the medical device requires the applicant to further complete the relevant work after the product is listed, and will be required to be set out in the medical device registration certificate.
Article 39 For the accepted application for registration, in one of the following cases, the food and drug supervision and management department to make a decision not to register, and inform the applicant:
(a) the applicant on the proposed market sale of medical devices for the safety and efficacy of the research and its results can not prove that the product safety, effective;
(b) the registration of the declaration of information is false
(C) the registration of the information is confusing, contradictory;
(D) the content of the registration of the information is inconsistent with the declaration of the project is obvious;
(E) do not register the other circumstances.
Article 40 For the accepted application for registration, the applicant may, before the administrative licensing decision is made, apply to the food and drug administration department accepting the application for withdrawal of the application for registration and the relevant information, and state the reasons.
Article 41 For the accepted application for registration, there is evidence that the registration declaration information may be false, the food and drug supervision and management department may suspend the approval. After verification, according to the conclusion of the verification to continue to review or make a decision not to register.
Article 42 If the applicant disagrees with the decision of not registering made by the food and drug administration department, the applicant may, within 20 working days from the date of receipt of the notice of the decision of not registering, file an application for review with the food and drug administration department that made the approval decision. The content of the application for review is limited to the original application and the original declaration.
Article 43 The Food and Drug Administration shall make a decision on review within 30 working days from the date of acceptance of the application for review, and notify the applicant in writing. Maintenance of the original decision, the Food and Drug Administration no longer accept the applicant to apply for review again.
Article 44 The applicant for the food and drug supervision and management department of the decision not to register objections, and has applied for administrative reconsideration or administrative litigation, the food and drug supervision and management department does not accept the application for review.
Article 45 of the medical device registration certificate is lost, the registrant shall immediately in the original licensing authority designated by the media published a statement of loss. After one month from the date of publication of the lost declaration, the registrant shall apply to the original licensing authority for reissuance, and the original licensing authority shall reissue the certificate within 20 working days.
Article 46 The application for registration of medical devices directly involves the applicant and others with significant interests,
Food and Drug Administration shall inform the applicant, the interested party can be in accordance with the laws, regulations and other provisions of the State Food and Drug Administration enjoy the right to apply for a hearing; on the application for registration of medical devices
examination. Food and Drug Administration that are involved in public **** interests of major licensing matters, shall be announced to the community, and hold a hearing.
Article 47 of the newly developed medical devices have not been included in the classification of the catalog, the applicant can apply directly for the registration of Class III medical device products, can also be based on the classification rules to determine the product category and to the State Food and Drug Administration to apply for confirmation of the category, apply for product registration or for the product record.
Directly apply for registration of Class III medical devices, the State Food and Drug Administration in accordance with the degree of risk to determine the category. Domestic medical devices to determine the second category, the State Food and Drug Administration will be declared to the applicant's location in the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration for review and approval; domestic medical devices to determine the first category, the State Food and Drug Administration will be declared to the applicant's location in the municipal
food and drug supervision and administration departments For the record.
Article 48 The application for registration in the process of review and approval of patent disputes shall be dealt with in accordance with relevant laws and regulations.