Pre-market Regulatory Analysis

Obtaining the recording or registration certificate from CFDA is the first step for medical device to legally sell medical device in China. The management and supervision for medical device in China is steadily becoming standardized and stringent.
 
In order to help registrant successfully and smoothly obtain the recording/registration certificate. CIRS provides regulatory analyzing report for all the medical device registrants. The reports as headstone for recording or registration procedure that help registrants to understand the potential risk, estimated period and cost, requirements of testing/clinical trials about the recording or registration.
 
What information will be included in our full pre-market regulatory report?
  • Product analysis, including classification of medical device, requirement of testing and clinical trial
  • Registered similar product in CFDA
  • Relevant regulation, standard, guidance for your medical device registration
  • Gap analysis and risk analysis (if need)
  • Detailed regulatory procedure
  • The checklist of required dossiers for registration.
  • Registration estimated cost & timeline 
  • Others. (please tell us what other info you would like to have from our service)  
 
Why choose CIRS?
  • Multifaceted analysis
  • Elimination of legal compliance barriers for initial registration companies
  • Familiar the whole registration procedure and find the potential risk
  • Detail and specific procedure explanation to help the registrant understand
  • Based on CIRS professional experience, provides suggestion for effective registration pathway
  • CIRS provides English report service to help the registrant to elimination the language barriers.    
 
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 questions or comments, please contact us at md@cirs-group.com


Contact Us
CIRS China

Ms. Elaine (Head office)
Tel: +86-571 87206559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mrs.Emily (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Ms. Louise Halpin
Tel: +353 41 9806 916 | Fax: +353 41 9806 999
Email: md@cirs-group.com