IVD Reagent

With the increase of living and medical standards, the Chinese market for IVD reagents expanding, offering manufacturers a promising opportunity of development.

In the other hand, the country has been strict with the registration of IVD reagents, resulting in complicated registration (filing) process, which will cost plenty of time and efforts to bring the product into market, if no professional guidance on registration is available.

QME is equipped with abundant experience in IVD reagent registration and features a team of experts in IVD reagents and regulations. We are able to provide fast and high-quality IVD reagent registration (filing) services.

Our services cover the whole process of IVD reagent registration (filing), including:

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 class II and III IVD reagents that require 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 IVD reagent registration in our website. If you need detailed consulting services, please contact us via:

Tel: 86-10-62253808

Email: service@qiminer.com