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Registration Change of Class II, Class III MD

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.

Documents List

Flow Chart

Registration changes:

1. Name and domicile of the registrant;

2. Name of agent and production address of the residence;

3. Domestic medical device production address;

License changes:

1. Product name;

2. Model;

3. Specifications;

4. Structure and composition;

5. Scope of application;

6. Product technical requirements;

7. Imported medical device production address;

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Beijing

Shanghai

Shenzhen

Add：6th Floor, Building 3, No.1 Hangfeng Road, Fengtai District, Beijing
Tel：010-6331-1696/97/98
Web：www.runhugemedical.com
E-mail：mo@runhugemedical.com

Tel：010-6331-1696/97/98
Web：www.runhugemedical.com
E-mail：mo@runhugemedical.com