9999js金沙老品牌(中国)有限公司-Macau Future Star

Service Item
Registration Change
Class II refers to medium-risk medical device and its safety and effectiveness can be ensured by strict control. Domestic manufacturers need to register their medical device in the provincial CFDA or municipalities where applicant located. Overseas manufacturers should designate a domestic agent to register in NMPA. Class III refers to higher-risk medical device and its safety and effectiveness can be ensured by taking special measures to strictly control. Both foreign and domestic manufacturers need to register their product in NMPA.

二三类延续注册.jpg

Change of registration items:


1. The name and address of the registrant;


2. The name of the agent and the address of the address of the residence;


3. The production address of domestic medical equipment;


License changes:

1. Product name;

2. model;

3. Specifications;

4. Structure and composition;

5. Scope of application;

6. product technical requirements;

7. The production address of imported medical equipment;


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