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.

1. Documents preparation

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

3. Technical reviews

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