China Overhauls Medical Device Regulations — UPDATE

As noted in last month’s eNewsletter, China has been working on significant revisions to its medical device laws. On March 31, 2014, the Chinese government released amendments to the “Regulations on the Supervision and Administration of Medical Devices.” These regulations will go into effect June 1, 2014. The China Food and Drug Administration (CFDA) has further announced that more than 30 supplemental implementation regulations will also be released throughout 2014.

The revised regulations expand the definition of medical devices to be more inclusive. In addition, based on health risk, a device will be classified as Class 1, Class 2 or Class 3 (low to high). CFDA or provincial FDA registration will not be required for Class 1 devices — though a notification should be filed with the applicable local FDA. Distribution of Class 1 or 2 devices will generally not require prior official approval — though Class 2 device distributors must submit notification documents to the local government. Although approval for distribution of Class 3 products will be required, this application can be made to local FDAs.

The revised regulations call for increased compliance with good manufacturing practices (GMP) for manufacturers and good supply practices (GSP) for distributors. The amended laws also aim to promote research and development. For instance, it will be possible to be granted an exemption from clinical trials for Class 2 and 3 medical devices that have a solid record of safety.

Government regulations and systems will be strengthened to monitor device recalls and adverse events, trace high risk products and re-evaluate devices. Local FDAs will be given investigational powers and will be required to increase their post-market oversight. Penalties for manufacturers and distributors that are not following the applicable regulations have been expanded and could include criminal charges.

For more details, please see PBM’s recently published article on CFDA Medical Device Regulatory Updates.