On February 13, 2014, the Chinese State Council approved a revised Medical Devices Regulations, which was first adopted in 2000. The revision of the bill started in 2006, with a draft submitted to the State Council in early 2008. The updated regulation has 8 chapters, with 80 articles. The CFDA notice did not include specific dates for implementation or specify how long companies will have to comply with the new regulations.
According to the CFDA, the revisions include:
- Changes to the medical device definition and device classification rules
- Improved CFDA management of product registration, approval and administrative records of device manufacturing and distribution
- Measures for device manufacturing quality supervision and risk control
- Strengthened post-market surveillance of device adverse event monitoring, tracking and recalls
- Expanded device distribution inventory management, inspection and certification
- Enhanced requirements for supervising the use of devices
- Increased punishments for violations of the law
To learn more about new medical device regulations in China, please see our recent China webcast.
On February 20, the CFDA also released a draft revision to China’s Drug Registration Regulation. Public comments were due March 23. In comparison to an earlier draft released in November 2013, the new draft tweaks some of the legislation on generic drug filings. In the new draft, manufacturers can file generic applications at any point during the patented drug’s exclusivity period, instead of only two years before expiration, as in the current law. In addition, generic drug application approvals will only be effective after the patented drug’s patent expires — not before.