CFDA Alteration Registration Dossier Preparation

China Food and Drug Administration (CFDA) issued ‘Imported Medical Device Alteration Registration Approval Service Guideline’ on March 27th 2017. This guideline standardized the imported medical device registered Items alteration. Here is the list of the required documents.

Alteration Registration Dossiers Preapration

No.	Name of the Documents
1	Application form
2	The new product post market approval certificate from the oversea registrant registered country or production country. (If any)
3	The registrant statement about the alteration situation
4	Copies of original registration certificate and attachment
5	Copies of previous alternation documents
6	The alteration related application document requirements: The registrant name alteration--Submit the company name alteration approval notice (domestic registrant) or detailed alteration situation explanation and related supporting documents. The registrant name alteration-- Submit the alteration situation explanation and related supporting documents Agent alteration—Submit the declaration about agent modification provided by registrant；Photocopy of business license of new agent；Power of attorney and letter of commitment about new agent issued by the registrant. Agent address alteration--Submit the old and new version of the business license duplicated copy or copy of institution registration certificate.
7	The new enterprise qualification Certificate from the oversea registrant registered country or production country. (If any)
8	Power of attorney from agent that appointed by the oversea registrant.
9	Letter of commitment from the agent
10	Agent business license duplicated copy or copy of institution registration certificate
11	Declaration of Conformity and list of conformed standard
12	Original or English version notarized documents issued by registrant original resident notary authority

* If you have any comments or questions, please contact us at md@cirs-group.com.

Related Links

Imported Medical Devices CFDA Registered Items Alteration Guideline

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