Recalls of Medical Device Regulation Updated

Recalls of Medical Device Regulation Updated .

On September 2nd 2016 a new draft for handling recalls of medical devices has been released. The revision will replace the current regulation 82/2010 from the Chinese Ministry of Health dated 28.06.2010. It describes the key points leading to a recall.

1. If the medical device poses hazardous risks
2. If the medical device does not meet the regulation standards
3. If during manufacturing and/or distribution violations of the current medical device regulations occur
4. If any further adverse events ask for a recall

The draft also gives some guidelines for the management of recalls.

1. When the recall occurs outside of China the appropriate departments of the NMPA have to be informed
2. Within China:
   – Monitoring the safety of medical devices
   – Communication, reporting and close cooperation with the NMPA
   – Organization of the recall – assessment, if applicable relabelling, modification of the quality manual and/or software up-grades. Also of course repairs or replacement of the device and its disposal have to be taken care of.
   – Compensation
   – Penalties

When there is proof of the defectiveness of the device, and the NMPA-Legal-Agent fails to report to the NMPA, the NMPA may initiate the recall.

Violation of the regulations can result in fines for the NMPA Legal Agent or even cost him his license.

Recalls will be published in the NMPA database stating details of the product, its manufacturer and NMPA Legal Agent.

For more information please contact us:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com