For medical devices there are a number of exemption lists waiving the requirement for in-China clinical studies. But for diagnostics the rule is almost all Class II and III devices have to be supported by Chinese Clinical data
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a long list of Class II diagnostics proposed for approval without in-China clinical data.
On May 24th CFDA released a proposed “Second Wave” of Class II IVDs for exemption (A small handful were included in an earlier medical device exemption list). A total of 130 separate IVD tests covering a wide range of diagnostic uses are listed.
- Blood chemistry and protein assays,
- Troponin tests for myocardial infarction,
- IgG/A/M and IgG subtypes used in inflammatory disease diagnosis,
- Fecal occult blood assays,
- and more…
The associated guidance points to the acceptability of comparative analytical validation against a suitable predicate device already marketed in China.
This is a substantial move forwards and promises to dramatically curtail regulatory approval times and costs in China for a wide range of IVDs.
Considering entry to the China market? Our bilingual experts can support your China compliance needs. We support strategy, Type Testing, Clinical Evaluation, CFDA submissions, postmarket compliance and reimbursement. Contact us for a free, no obligation discussion. Email email@example.com or call +61 2 9906 2984 (Sydney) or +86 186 0062 2341 (Beijing)