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Center For Medical Device Evaluation (CMDE) - CFDA release supplementary information requirement

On May 22, 2013, Center For Medical Device Evaluation (CMDE) CFDA published a bulletin on issues relating to supplementary information about medical device registering and reviewing, executed from June 1, 2013. This bulletin is mainly aimed at the third class medical device in China and foreign medical device. The detailed contents are following:
 
One. During reviewing the registration application of medical device products, if additional information is needed, our center will inform the applicants the required information at one time. Then, the applicants should submit the required comprehensive information at one time according to our requirement within 60 working days. If the additional information could not be submitted at the provided limited time and also no justified reasons are presented, the center will give suggestions of suspending the review.
 
Two. Since releasing this bulletin, if the registration application is reviewed at the first time and supplementary information is needed, our center will issue the notification about adding information, after that, if the supplementary information submitted is not consistent with requirement, we will suggest that this application cannot be registered in principle. But, if some prescriptive or proved information should be submitted proceeding after the first supplementary information submitted, we will issue the second notification and the applicants can submit the additional information within 15 working days. If the information submitted at the second time is not consistent with requirement, we will suggest that this application cannot be registered.
 
Three. Before the date of releasing this bulletin, the registration applicants that have received the requirement of additional information have submitted the supplementary information that did not apply to the requirement, we will issue the second notification and the applicants can submit their additional information again. If the information submitted at the second time is still not consistent with requirement, we will suggest that this application cannot be registered.
 
Four. In the process of submitting supplementary information, if the applicants could not submitted the information within 60 working days, during that time, the applicants can submit written application for extension only once and the extension is no more than 60 working days.The information can not be submitted until the due data, the center will give suggestions of suspending the review.

Five. If the applicants do not understand the contents in the notification or have different opinions, they could consult the reviewer of CMDE by telephone, on-the-spot or written form.
 
The publication of the bulletin indicates that medical device registration requirements in China become more strict and the applicants have only one opportunity to supply information, hoping the medical device enterprises could pay more attention on this.


China cancelled CCC Certification of medical device

 
The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ), China Food and Drug Administration?CFDA? and Certification and Accreditation Administration of the People’s Republic of China (CNCA) jointly issued a public announcement about cancelling CCC certification of medical device on May 2, 2013.

Since this bulletin is issued, eight kinds of medical devices have been incorporated into the medical device registration management instead of compulsory product certification management, these device include medical x-ray diagnostic device, hemodialysis device, hollow fiber dialysis, blood purification device of extracorporeal circulation, artificial heart-lung machine, ECG device, implantable cardiac pacemakers, latex condoms.

Specified certification agencies cancelled the certification for the above eight kinds of products and accept the certification mark which the enterprises already purchased but haven't used and after check the refund return enterprise.


MORE INFORMATION

Shenzhen Hlongmed Biotech Co., LTD
(China CFDA Registration / Medical Device Consulting)
Tel: +86 755 86664989  
Fax: +86 755 86664933
E-mail: consultant@hlongmed.com
Website: www.hlongmed.com
Add: 15-08, East Block,Yihai Plaza
Chuangye Road North, Nanshan
Shenzhen, P.R.China, 518054

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