What is the classification of medical device product changes?


Time:

2022-03-18

1. The contents stated in the registration certificate, including product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. This type of change belongs to the change of the license item, and an application for change registration should be submitted to the original registration department. Generally, technical review and administrative approval are required. If there is a substantial change, an on-site assessment is also required. 2. The contents stated in the registration certificate, including the name and domicile of the registrant, the name and domicile of the agent, and the house number of the production address, etc. This type of change belongs to the change of the registration item, and the original registration department should apply for the record of the change item

1. The contents stated in the registration certificate, including product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. This type of change belongs to the change of the license item, and an application for change registration should be submitted to the original registration department. Generally, technical review and administrative approval are required. If there is a substantial change, an on-site assessment is also required.

2. The contents stated in the registration certificate, including the name and domicile of the registrant, the name and domicile of the agent, and the house number of the production address, etc. This type of change belongs to the change of the registration item, and the original registration department should apply for the record of the change item


Copyright © Yangzhou Qinye Medical Equipment Co., Ltd.  Powered by:www.300.cn  SEO

Business license