The China Food and Drug Administration (CFDA) has released a long-anticipated draft Classification Catalog of Medical Devices that contains more specific categories and provides clearer guidance to manufacturers.
The draft catalog is not yet available in English, but according to attorney Anna Zhao at Covington & Burling the document:
The draft catalog also contains a new medical software section with five primary categories for treatment planning, image processing, data processing, IVD, and decision support, as well as a catch-all entry.
Zhao said the current catalog, which was issued in 2002, has been criticized for not providing clear guidance to manufacturers seeking a classification decision. In particular, it does not include product descriptions and intended uses for some categories of products. The categories also overlap, which can lead to inconsistent determinations. By contrast, the new draft catalog is a lot more concrete and granular, she said.
The 2002 catalog is outdated and “fails to keep up with the rapid proliferation of medical devices and the growth of complex technologies that have taken place in China,” said Grace Fu Palma, founder and CEO of China Med Device, a Boston-based consulting firm that helps U.S. medtech companies expand into the Chinese market.
The draft catalog has significant implications for medical devices registrations and renewals, Fu Palma said. In particular, if a device is not included in the draft catalog, a manufacturer must go through an expert panel forum to get it listed, which is time-consuming and costly, she added.
The draft catalog does not cover in vitro diagnostic devices other than software, because IVD devices have a separate sub-catalog issued in 2013.
Release of the draft catalog is one of the final changes stemming from a 2014 revision of China’s primary vehicle for regulating medical devices, the Medical Device Supervision and Administration Regulations. The draft is expected to be finalized quickly, perhaps early this year.