CFDA issued second list of Class II devices exempt from clinical studies (10/11/13)

[treesei]

CFDA issued the second list of Class II devices that are exempt from the requirement of clinical test data for product registration. Manufacturer may send a written request for such exemption. The list is effective on the day of issuance and does not apply to any registration submission sent in before that date.

https://www.sda.gov.cn/WS01/CL0845/93220.html

 

[Burgmeister]

Re: CFDA issued second list of Class II devices exempt from clinical studies (10/11/1

Is this info available in English anywhere?

Cheers

 

[treesei]

Re: CFDA issued second list of Class II devices exempt from clinical studies (10/11/1

Unfortunately not I am aware of.

Regards.

 

[Ajit Basrur]

Re: CFDA issued second list of Class II devices exempt from clinical studies (10/11/1

Is this info available in English anywhere?

Cheers

Thats the sorry part of the Chinese regulations ... there is no official English version.

 

[sreenu927]

Re: CFDA issued second list of Class II devices exempt from clinical studies (10/11/1

See attached English version from Google translated. Might be helpful.

Regards,
Sreenu