In order to guiding registration applicant to prepare and compile the technical documents for Fetus's chromosome aneuploidies (T21/T18/T13) detecting reagents kit (High-Throughput Sequencing Method), as well as to guiding technological evaluation for review staff, Center for Medical Device Evaluation CMDE) has started the work of compiling the Guideline for Technical Review of Fetus’s Chromosome Aneuploidies (T21/T18/T13) Detecting Reagents Kit (High-Throughput Sequencing Method).
In order to collecting more information about the reagents kit, CMDE calls for manufacturers to get more involved in this Guideline Compilation.
If you want to take part in the Guideline Compilation, you can fill your information as the below table, and email it to us at windy@cirs-group.com before Jan 31th, 2016. We will help you to submit it to Center for Medical Device Evaluation. Click here to download the Table.
For any further enquiries, please feel free to contact us.
Contact: Windy Jin
Email: windy@cirs-group.com
Oversea Manufacturer:(Download)
Full Name of Manufacturer | ||
Country | ||
Full Name of China’s Agency | ||
Address of China’s Agency | ||
Postcode of China’s Agency | ||
Contacts of China’ Agency | ||
Telephone of China’s Agency | ||
Fax of China’s Agency | ||
Contacts’ Email of China’ Agency | ||
Overview of products’ registration and R&D | Production varieties which have been approved | |
Production varieties which are expected research or applying for registration |