Manufacturers seeking to enter the Chinese market will be familiar with the requirement to conduct Type Testing. Essentially a testing of a product sample against a technical standard (the Product Technical Requirement) which is usually based on a national product standard in China. Type testing adds 3-6 months to the product approval process and is a prerequisite to obtaining a clinical trial approval in China.
We reported recently on the abolition of Type Testing fees and cautioned on the negative effects this may have. Recent events in China suggest the fee abolition is a precursor to a rethink on the whole approach to Type Testing.
The challenge is that apparently the lost fee revenue has not been replaced by any other source funding for the Test Centers to conduct testing. This has led to some test centers ceasing registration testing altogether, and others to suspend accepting new orders. Some have identified alternative ways of managing the situation, including the introduction of fee based pre-testing to assist in ensuring compliance prior to submitting for formal regulatory testing. Nonetheless, all of this is causing great consternation and uncertainty, with manufacturers facing difficulties in establishing new Type Testing contracts.
So what’s going on?
Type testing was a hot topic on the sidelines of the recent CIMDR conference in Hangzhou. It does appear that CFDA is contemplating moving away from Type Testing of imported medical devices and IVDs and to switch to acceptance of test certificates from accredited third party laboratories. This would of course be excellent news in the longer term as it would allow products to proceed directly to registration filing, with the filing supported by existing product test certifications. But right now there’s no formal policy decision or timing indications around when this may in fact be implemented. Considering previous experiences, we may see a decision made tomorrow, or it could be several months away. In the short term, type testing is creating uncertainty.
We will continue to watch developments closely. Watch this space for news of any policy shift in Type test requirements.
Seeking China market access? With offices in Beijing and a team of bilingual experts in both our Sydney and China offices, we can support your CFDA regulatory filings. Contact us today about clinical evaluation in China, Type testing or CFDA submissions. Email firstname.lastname@example.org or call +61 2 9906 2984