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