1, a class of medical equipment record certificate is valid for five years
According to the "supervision and management of medical devices regulations (State Council Decree No. 650)" Article XV
Medical device registration certificate is valid for five years. The expiration of the validity of the need to renew the registration, should be valid six months before the expiration of the original registration department to apply for renewal of registration.
Except for the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiration of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
One of the following circumstances, shall not be renewed:
One, the registrant did not apply for renewal of registration within the prescribed period;
Two, the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements;
Three, for the treatment of rare diseases and respond to public **** health emergencies in urgent need of Medical devices, medical device registration certificate is not completed within the specified period of time the matters set out.
2, the second class business filing application to the application can be used all the time there is no deadline.
Extended information
Two types of business filing two types of application materials:
1, the second class of medical equipment business filing form;
2, business license and organization code certificate copy;
3, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person, education Or a copy of the title certificate;
4, organizational structure and departmental setup description;
5, business scope, business mode description;
6, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or by the housing rental issued by the lease certificate copy;
7, business facilities, equipment directory;
8, business quality management system, work procedures and other documents directory;
9, the operator's proof of authorization; where the application for the enterprise declaration materials, the processing staff is not the legal representative or the person in charge of the enterprise himself, the enterprise should submit the "power of attorney";
10, other supporting materials. (Declaration of the authenticity of the self-assurance statement, including the catalog of application materials and the enterprise on the material to make if false to assume legal responsibility for the commitment (original 1).
Reference:
Medical device supervision and control: the medical devices of the world's largest medical device manufacturers. p>Baidu Encyclopedia - Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 650)
Luohe Food and Drug Administration - Regulations on the Filing and Handling of Class II Medical Device Businesses