shimonv
Trusted Information Resource
Hello Colleagues,
Attached is good english translation for CFDA's Technical Guidelines for Clinical Evaluation on Medical Devices. It become effective since May last year and poses a great deal of challenge to medical device manufactures.
In fact, it's a lot more difficult than the European guidance for CER (MEDDEV 2.7/1 rev.4 ).
I trust it will be helpful for those of you aiming at the China market.
Best,
Shimon
Attached is good english translation for CFDA's Technical Guidelines for Clinical Evaluation on Medical Devices. It become effective since May last year and poses a great deal of challenge to medical device manufactures.
In fact, it's a lot more difficult than the European guidance for CER (MEDDEV 2.7/1 rev.4 ).
I trust it will be helpful for those of you aiming at the China market.
Best,
Shimon