On June 11, 2018, CFDA released their latest proposals for medical device and IVD clinical trial exemptions covering another 85 devices and 277 IVDs.
This proposed “4th wave” exemption list breaks down into 66 class II and 19 class III devices, 246 class II IVDs and, for the first time – 31 class III IVDs.
In addition to exempting a whole lot more devices and IVDs, this announcement also updates the previous Waves 1-3 exemption lists to align them with CFDA’s new classification catalogue – which goes live in August. The new exemption list specifies the full product name, classification category number, and product description. 141 class II and 36 Class II devices have been updated to the new catalogue definitions.
This is a large and wide-ranging list. It includes a large number of class II medical devices including all devices in the following catalogue sections:
2. Passive surgical instruments
3. Neurological and cardiovascular surgical instruments
11. Instrument disinfection and sterilization equipment (Sub-category II)
16. Ophthalmic instruments (Subcategory II non-active devices)
18. Obstetrics and gynaecology, assisted reproduction and contraception (Sub-category II non-active devices)
The revision of the previously released 3 waves of clinical trial exemption lists also re-structured according to the new Medical Device Classification Catalogue, including adjustment on 141 class II products and 36 class III products. Revision includes 4 types, i.e. adjustment on product name/description, merge/split, classification changes, and classification number changes.
The Class III IVD exemptions appear for the first time. However, it’s important to know that for all exempt IVDs there is still a requirement to do a clinical lab-based validation study. Nonetheless, it’s a smaller requirement and comes at a fraction of the cost – with up to 90% savings for Class III IVDs.
Remember – this is still an exposure draft. The short three week comment period closes at end of June and we would expect to see CFDA move fairly quickly to a final version – probably in the third quarter of the year.
On the list? We can help you find out if your device or IVD is exempt – or requires in China trials. We offer complete regulatory and clinical trial support. Our China-based regulatory experts can provide a direct interface to CFDA and a full local license holding service. Contact us now to learn how we can help you. Email firstname.lastname@example.org or call:
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