Medical Devices (includes In Vitro Diagnostics)
The China CER requirement is described in the Technical Guideline for Clinical Evaluation of Medical Device, which is understood by many to be similar to the EU MEDDEV 2.7/1 rev.3 requirement; it currently serves for foreign medical device manufacturers to submit a minor revised EU CER directly to NMPA. This results frequency in the receipt of a deficiency letter from the Chinese NMPA.
China CER strictly requires the comparison between device under application and equivalent device, and any of the identified differences must be proven in terms of safety and efficiency by clinical use data, literature, and/or non-clinical data from both the device under application and the equivalent device.
This session will explore best practice on getting clinical data documented in accordance with the Chinese regulation.