CFDA Interprets on How to Update Your Medical Device Registration Certificate

On Nov 2nd, 2015, CFDA issued a notice that help explain how to update your medical device registration certificate. This notice can solve the main problems while applying for registration certificate alteration.

1. What is record alteration and approval alteration?

Pursuant to Administrative Measures of Medical Device for Registration, if the content of registration certificate and its attachment has been changed, you shall apply for registration alteration to CFDA.

Registration alteration is divided into record alteration and approval alteration.

If the content those you would like to alter is not in the registration certificate or its attachments, you shall carry out related tasks according to your quality management system, to ensure the quality management system can be performed continuously and effectively.

2. What information needed to prepare for record/registration alteration?

(1) Basic Documents

2.1 Application form;
2.2 Declaration of alteration situation;
2.3 Copy of original medical device registration certificate and its attachment;
2.4 Copy of previous registration alteration files;
2.5 New sale certificate and business license of the country of original (if any);
2.6 Power of attorney of China agent;
2.7 Copy of business license and Letter of commitment of China agent;
2.8 Declaration of conformity;
2.9 Notarized copy of original/English document provided by registrant's local notary organization.

Note: if there are no documents of 2.5, you shall submit the explanation.

(2) More for Record Alteration

2.10 Supporting document for different alteration item:
For register name alteration, you shall submit the Enterprise Name Change Approval Notice and/or corresponding statement of detailed alteration situation and documentary evidence;
For register address alteration, you shall submit the statement of detailed alteration situation and documentary evidence;
For China agent alteration, you shall submit the declaration of agent alteration, the copy of business license and power of attorney of new agent, as well as letter of commitment;
For China agent address alteration, you shall submit the copy of original and post-alteration business license;

(3) More for Registration Alteration

2.10 Comparison table and explanation of Change of Product Name/ Model and Specification/Structure and Composition/Application, etc.;
2.11 Product change-related safety risk management report;
2.12 The data on the impact of changing part on safety and efficacy of product.
2.13 Registration inspection report aimed at the changing part of technical requirements;

3. Whether can apply for record alteration and registration alteration simultaneously?

In according with Announcement about Related Problems of Registration Application for Medical Device and In Vitro Diagnostic Reagent, you can apply for record alteration and registration alteration either respectively or simultaneously.

If you want apply alteration together, you shall fill application form of record alteration and application form of registration form respectively, and indicate that merging the record alteration and registration alteration in the column "Other issues need to be addressed". For same documents of 2.1-2.9, you can provide one originals and one copies. Originals can be submitted with any application form for alteration, and the copies of another alteration shall be indicated the source of the originals.

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