Article 49 has been registered Class II, Class III medical devices, medical device registration certificate and its annexes to the content of the change, the registrant shall apply to the original registration department to apply for changes to the registration, and in accordance with the relevant requirements for the submission of declarations.
Product name, model, specifications, structure and composition, scope of application, product technical requirements, imported medical devices, such as changes in the production address, the registrant shall apply to the original registration department for licensing changes.
Another issue, the expiration of the registration certificate is not a simple replacement, because according to Order No. 4, Chapter VII Renewal of registration
Article 54 The expiration of the registration certificate of medical devices need to continue the registration, the registrant shall be in the expiration of the certificate of registration of medical devices before the expiration of six months, to the food and drug supervision and management to apply for the continuation of the registration, and in accordance with the relevant requirements for the submission of reporting information.
In addition to the provisions of Article 55 of these measures, the application for renewal of registration of food and drug supervision and management departments should be received before the expiration of the validity of the medical device registration certificate to make a decision on the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
Article 55 of the following circumstances, not renewed registration:
(a) the registrant did not apply for renewal of registration within the prescribed period;
You should be re-registered as a new product
.