China has published its long awaited update to medical devices classification rules, for implementation in 2016. The new rules follow much of the precedents of the GHTF rule set, but with some significant differences – not least of which is that they are applied by the regulator and not by the manufacturer.
As flagged in our earlier review of the consultation draft, the final new rules include some substantial differences particularly in treatment of wound dressings.
The Chinese rules treat circulatory system contact very differently to the GHTF/European model, with circulatory system broadly defined as all vessels except capillaries. The final rule also adds a new section classifying load bearing orthopaedic devices as Class II or above – allowing some flexibility and aligning with the US FDA approach to these devices, which contrasts to the approach taken in Europe, Australia and other users of the GHTF regulatory model where all load bearing joints are Class III.
The most fundamental difference in approach in China compared to GHTF members is that the classification rules are intended for use by CFDA for the purpose of developing a classification catalogue. They are not expected to be applied directly by the manufacturer to determine the class of their own device. If a manufacturer has a new device not covered in the catalogue – they have to apply to CFDA to verify the classification (according to the rules of course) and create a new catalogue entry.
Although broadly following the GHTF paradigm, these rules are drafted with plenty of room for interpretation and introduce some new concepts such as use of “impact on treatment outcome” to classify non-contacting devices.
Classifications for IVDs are not included within this rule set – apart from a brief reference to the ability of the CFDA to set rules at some future date.
The rules provide insight into the CFDA’s approach – but ultimately – you need to consult the classification catalogue to confirm where you stand.
The rules will be enforced from 1 January 2016.
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