Going back to find out when the application for CFDA approval...

Going back to find out when the application for CFDA approval was lodged, I thought it appropriate

to revive this thread and a couple of posts to remind all that CFDA Certification could fall any day now.

I have attached a Medical Device CFDA Timeline application process, not sure which applies to GMV

But it is current as of March 2018

I refer to @charliben 's date of May 17 as an approx application date

Class 1 medical devices could take up to 13 months

Class 11 and 111 from 15 months to 26 months

Happy to be corrected

GLTAH PDYOR




Process of CFDA Application
The following process flow chart provides a brief overview of the CFDA application process and the necessary steps. For a more detailed description of the application process for Chinese medical device registration, please read our free CFDA-booklet.
According to the decision of the Central Committee of the CCP on March 17th, 2018, the CFDA was replaced by the NMPA (National Medical Products Administration). However, related regulations and personnel responsibilities are expected to remain unchanged. Until the legal and structural changes of the authorities are completed, the term CFDA is still in use.

Based on the risk class, different steps in the application process must be taken with different supporting documents being submitted.
According to the Chinese regulations, re-certification must be done every 5 years.
CFDA Process of the Classification and Registration of Medical Devices

• Application documents as well as all relevant supporting documentation must be provided. The manufacturer will need to classify their product into Class I, Class II or Class III, based on risk factors.
• All application and supporting documentation must be submitted to the CFDA. They will review application, supporting documents and classification and accept, reject or re-classify.
• The medical device will be tested by a CFDA approved test laboratory in China.
• Legal and technical supporting documentation may be requested.
• Clinical trials will be conducted (if required).
• Evaluation of product test and/or clinical trial is done by the CFDA. Final results will be presented in a technical and administrative report.
• If the device is approved, a certificate of the registration and license will be issued.

Please note that only after handing in all application documents will the CFDA decide whether a medical device registration is possible (usually within 30-60 days after application). There is the possibility that the application is rejected by CFDA, if this should happen an explanation and statement will be provided to the applicant.
Expert CFDA Consultation from China Certification Corporation will reduce the time and expense when seeking CFDA registration for your medical device.