Class I Medical Device Recording Service

According to the regulation issued on March 7^th 2014 ‘Regulations for the Supervision and Administration of Medical Devices (Decree NO. 650)’, all the imported Class I medical device should apply and acquire the certification of Class I Medical Device Record Keeping from China Food and Drug Administration (CFDA).

CIRS devotes to help medical device manufactures to quickly and effectively comply with CFDA regulations and requirements. CIRS Class I medical device recording service will help the manufactures to furthest save the cost, period and workload of recording procedures.

Who should submit the application?
Domestic and Oversea Class I medical device manufactures

CFDA recording challenges for imported class I medical device manufactures

Legal representatives
The determination of class I medical devices
Dossiers preparation that conformed to the CFDA requirements.

Why you choose CIRS?

Elimination of legal compliance barriers for initial recording companies
The highest efficiency to obtain the recording certificate
Elimination of language barriers.
Intellectual Property protection

Our Team:
CIRS Medical Device Service Team consists of many experienced registration and clinical experts with master’s and above in medical background. Medical Device Service Team divides into three professional groups, including Regulatory affairs service group; Clinical trial service group and Custom Service group. We have good relationship network with other professional industry institutions and we aim to provide the best professional, efficient, permanent and all-around service for our client.

* If you have any comments or questions, please contact us at md@cirs-group.com.

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