It has been a relatively quiet summer from the CFDA. But since September there have been a couple of new development in the regulatory requirements for medical devices. Today we highlight two CFDA updates that may be of interest to the foreign manufacturers.
Second clinical trial exemption list is now official!
At last, following the draft version made in public in May this year, the long awaited second list of medical devices exempted from in-China trials was finalized and made official by CFDA as of 30th September 2016.
This second list will , as the CFDA put it, reduce the registration workload for the manufacturers, improve the registration approval efficiency, and fulfil the medical needs in time.
Among this new list, there are 267 Class II medical devices and 92 Class III medical devices which can be registered with CFDA without additional clinical investigation data from China. Combined with the first exemption list which was published in 2014 and included 488 Class II and 79 Class III, this 2nd list will undoubtedly make selective product registrations in China relatively more straight forward. Notably, this time CFDA has doubled the amount of Class III devices in the trial exemption list, which showed the confidence of CFDA in the maturity of the technologies and manufacturing of those long-standing devices.
This constitutes positive news for many foreign manufacturers who were facing the cumbersome registration process in China. Typically for the CFDA registration, if there is no necessity to conduct a clinical investigation in China, the registration timeline can be significantly shortened and sometimes even halved. For instance, a Class III medical device registration with clinical trial in China can take 16 up to 36 months (a rough estimation) before the manufacturer obtains CFDA approval. However, without clinical trial, the same registration process can be completed within 10 to 14 months (an estimation still).
CFDA started updating the Medical Device Classification Catalogue
At the end of September, CFDA published a new device classification catalogue (DRAFT), which gives a significant facelift to the old 2002 version. This new catalogue is a collaborative work between CFDA registration office, Center for Medical Device Evaluation (CMDE), medical device standardization technical committees and some medical device testing labs. New updates compared to the 2002 version include:
- More detailed grouping. The new catalogue will embrace a 3-tier grouping scheme, instead of the 2-tier grouping in the 2002 version. The original 265 groups from the 2002 version will be divided into 205 2nd tier groups and 1136 3rd tier groups.
- More up to date. The new catalogue will more appropriately reflect the technological development in the MedTech industry over the past decade, covering many newer (types) of medical devices.
- More substantiated classification. For the new catalogue, ‘device description’ and ‘intended use’ will be added, which can be used to facilitate the classification of a medical device on top of using the examples provided in the catalogue.
- Few down classifications. There will be some cases of down classification for devices which have been on the market for a long time, whose production processes has matured, and whose risks are known and deemed controllable.
For many manufacturers, this means that the new classification catalogue will ultimately live up to its name and become a useful tool for determining the classification. Currently, the most practical and probably the fastest way to confirm a device’s classification is to look into the CFDA registration database and to see how similar devices are registered in China.
Are you interested to know whether your device is covered by either of the two clinical trial exemption list in China? Or want to know more in depth on your market entry strategy in China? Contact Qserve
More information about Gert & Xiaoli: