This China regulatory change for IVDs will save up to 90% of clinical trial costs

This China regulatory change for IVDs will save up to 90% of clinical trial costs Brandwood Biomedical Global Medical Device and IVD Regulatory Services

China’s CFDA exempts many devices and IVDs from requirements for clinical trials to support registration.

Two weeks ago CFDA released their latest “4th Wave” of proposed clinical trial exemptions, which now include a total of 246 Class II IVDs. But the big news is the exemption for the first time of Class III diagnostics, with 31 tumor marker diagnostics added to the list. The exemptions remove requirements for in-China clinical trials – although like in other jurisdictions there are still requirements for clinical evidence and predicate comparisons.

China’s IVD clinical trial requirements are onerous, with large study sizes across multiple sites mandated by CFDA.  Although the agency is starting to entertain international clinical data, the reality is that most international trials will be smaller and won’t satisfy the CFDA needs, leaving an in-China trial the only option.

For manufacturers of IVDs – exempt status means the regulatory requirement changes from a full in-China premarket hospital trial to a much smaller validation study. This still has to be done in a clinical laboratory, but the scale of effort is much less saving time and money. The table below illustrates the difference.

Requires Clinical Trial
Validation study only
 Class IIClass IIIClass II or III
Sites:Minimum 2Minimum 3Single laboratory

Class II IVDs see the study sizes cut in half, but it’s the Class III devices which see the most dramatic savings. A reduction from a thousand to one hundred samples and a minimum of three sites to a single laboratory represents a 90% scale back of the study size.

And there are also big savings in the costs and time for ethics submissions. Gone is the need to pursue multiple ethics committee and HGRA approvals and all the back and forth negotiations involved. Now it’s a simple single lab-based validation under GLP.

All this could add up to a  90% saving on cost and shave many months from time to market.  That’s got to be good news.

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 [email protected] or call:

1 888-271-5063 (US toll free)    ♦   400-842 7017 (Beijing – toll free)   ♦    +61 2 9906 2984 (Sydney)


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