CFDA began to collect the information of manufacturer who produce Fetus’s chromosome aneuploidies (T21/T18/T13) detecting reagents kit - Regulatory News - Medical Devices

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 31^th, 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

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