Imported Medical Device

With many years of experience in medical device registration, QME provides MD registration (filing) services for class I, II and III MDs. We will make detailed registration (filing) plans for your products and provide superior service throughout the process from the signing of contract to the acquisition of certificate.

Our services include:

1.      Preparation prior to submission

a.      Determine classification of the product and detailed registration (filing) procedure according to national regulations; for new products not included in the directory, apply for classification;

b.      Assess and organize technical files provided by customer;

c.      Translate registration-related documents.

2.      Preparation of technical requirements

Compile technical requirements as per product information and testing requirements.

3.      Tests

QME will arrange tests for the product at different testing centers according to type of the product, and follow the testing process and provide technical support until test report is obtained.

4.      Evaluation of clinical data and conduct of clinical trials

For imported MDs that requires clinical trials to be conducted in China, QME’s clinical department will arrange medical facilities to conduct clinical trial and obtain clinical trial report. (See Clinical Trial for details)

5.      Application for registration (filing)

6.      Follow-up of evaluation process

7.      Supplement of additional data

Supplement additional data as required by relevant authority, and arrange expert review for the product when necessary.

8.      Acquisition of certificate

You are welcome to check more information about medical device registration in our website. If you need detailed consulting services, please contact us via:

Tel: 86-10-62253808