Renewal of Registration Certificate for Imported Medical Device in China

Foreign manufactures who sell their products in China shall get Record Certificate for Class I medical device and Medical Device Registration Certificate for Class II/III. Record Certificate will never expire so you don't need to renew it. But Medical Device Registration Certificate (so called CFDA certificate) is valid for a period of five years, so you have to renew it prior to expiration.

According to Administrative Measures for Medical Device Registration and relevant regulations, applicant shall apply for renewal of registration no later than six months before the certificate expires, or else the application will not be accepted by CFDA. As long as your renewal applications are submitted on time and being accepted, you can continue selling your products in China even if you are still waiting for the renew approval and your last CFDA certificate has expired, unless the renewal application is not approved by CFDA that you have to terminate your business.

How to renew the registration certificate?

1. Documents preparation

Firstly, you shall prepare application documents, as following:

(1). Application form for renewal of registration of imported medical device;

(2). Declaration of non-change of product;

(3). Supporting documents:

a. Copies of original Medical Device Registration Certificate and its accessories;
b. Copies of previous Change Documents of Medical Device Registration and its accessories;

(4). Product analysis report within valid period of registration certificate; the contents as following:

a. Clinical application situation;
b. Adverse events summarization, analysis and evaluation report;
c. Presentation of market conditions;
d. Supervision, testing and recall situation;

(5). Modified technical requirements (in duplicate). (If any changes are made to technical requirement within valid period of original medical device registration certificate)
(6). Test report
If the mandatory standards of medical devices are not revised, applicant shall not provide the test report. Once they have been revised, applicant shall provide the new test report, of which the performance index shall conform to the new standards;

(7). Power of attorney of China agent;
(8). Letter of commitment of agent;
(9). Copy of business license of agent;
(10). Declaration of Conformity and List of standards;
(11). Notarized copy of English/original documents;
(12). Other
If your Medical Device Registration Certificate is obtained before Oct 1^st, 2014, you need provide the following documents:

a. Original copy of product standards;
b. Technical requirements;
c. Comparison of technical requirements and product standard;
d. Label sample of minimum marketing unit;
e. Comparison of corresponding changes in instructions (if instruction has been changed).

2. Documents submission

Applicant shall submit the documents to CFDA. If the document is incomplete or fails to satisfy requirements of formal examination, officer will refuse to accept them and inform applicant of corrections.

3. Technical reviews

The documents will be turned over to center for medical device evaluation of CFDA (CMDE) for technical reviews.
CMDE will make reviews for contents of renewal of registration to ensure whether they conform to relevant regulations or not. If the documents meet the standards of technical reviews, experts will make a consent opinion and provide ‘Technical Reviews Report of Medical Device’; if the documents don’t meet the standards of technical reviews, experts will make corresponding opinion, and provide ‘Notice of Supplementary Materials’ to inform applicant to supplement absent materials. Applicant shall supplement the material one time within one year. Otherwise, MDE will terminate reviews.
For the accepted application, renewal registration is not allowed for any condition below:

a. Applicant don’t apply for renewal of registration within limited time
b. The product cannot meet the new requirements of revised mandatory standards.
c. For medical device in urgent need of rare disease treatment and dealing with public health emergencies, the applicant does not finish the items stated on the medical device certificate which proposed by the registration approval department.

4. Administrative approval

5. Certificate / Non-administrative licensing decision issuance

If the renewal of registration is approved, applicant will get the new certificate; otherwise, will get Non-administrative licensing decision.

Note: if applicant has objection to non-administrative licensing decision, you can state your opinions upon the decision and apply for re-review within 20 business days from the day receiving the result. The re-review content is limited to the original items and application documents.

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