Revised Medical Device Regulations Go into Effect in China

On June 1, 2014, China’s amended “Regulations on the Supervision and Administration of Medical Devices” went into effect. Class I medical devices — domestic and imported — no longer need to be registered with the China Food and Drug Administration (CFDA). Instead, a notification must be filed with the relevant local Chinese FDA. A foreign manufacturer should designate a Chinese representative agent to submit the notification dossier.

The CFDA has recently released several supplemental announcements for the filing of Class I medical device notifications. In order to classify as a Class I device, the intended use and description of the product should be within the scope of China’s Class I device catalog — including, if applicable, the IVD sub-category.

Compared with the previous application system for Class I medical devices, more information must now be included in the notification dossier. However, the dossier will only be assessed for comprehensiveness and accuracy. The majority of the documentation required in the dossier is the same as the documentation required for a medical device application in the U.S. and EU. Both English and Chinese dossier versions should be submitted. The CFDA is releasing further guidelines for Class II and Class III devices, including information on clinical trials and other pre-market requirements.

The Chinese State Council is also working to expand healthcare reform. More than half of the provinces in China must start trial reforms of public hospitals this year. China plans to encourage the establishment of private hospitals by making it easier to open a private institution and treating private and public facilities equally. Doctors will also be encouraged to go into private practice. Additionally, commercial health insurance will be developed, and coverage for serious illness will be improved.