Most IVDs have been more lightly regulated than other medical devices. A sweeping generalization I know – but consider: in Europe, most IVDs are considered Class I and marketed under self declaration to the IVD Directive requirements. In the US, there’s very widespread use of Laboratory Developed Tests as a means of circumventing FDA regulation. But it looks as though this is changing and paradoxically – the major markets of the US and Europe may be catching up with more developed IVD regulation in other parts of the world.
Health Canada has used a more conservative IVD classification and assessment system for many years. In Australia, 2015 saw the completion of transition to a similar classification structure. Similar classifications are being rolled out in some Asian jurisdictions notably Singapore. These more stringent regulations expect manufacture under ISO 13485 quality system and a review of Technical File data to confirm adequacy of diagnostic performance and analytical and clinical validation. Australia’s TGA has long accepted CE certification as an alternative to TGA direct assessment of medical devices. But not for IVDs – as the European arrangements for self declaration of most IVDs means there is no certificate. Australia’s TGA will however accept a Canadian MDALL license for registration of Class 2 IVDs.
Japan, Korea and China have long had more rigorous requirements for IVDs. Japan has taken a particularly thoughtful approach on Companion Diagnostics regulation – with a parallel regulatory review for CDx and medicine and a detailed guidance. Korea has recently published detailed guidance (in Korean) on Diagnostics Regulations . China especially has always insisted that IVDs be supported by clinical trials conducted in China and this was unchanged in the 2015 update of Chinese regulations.
The interesting thing in Australia was that costs of compliance with the new regulations led to a bit of a shake out in the market and a range of low volume tests were withdrawn. So as Europe moves to a new IVD classification and the US FDA starts to get tough on use of Lab Developed Tests it remains to be seen what effects this will have on the market. It seems likely that there will be at least some level of consolidation. It’s going to be an interesting year in IVDs.
Interested in Global IVD regulations? Consider attending the Asia Pacific Devices Summit in San Francisco, CA, March 10-11. Leading Experts from across Asia will present their experience and advice on how to succeed in the Asia Pacific market for Devices and diagnostics. With sessions on regulatory, clinical reimbursement and more it’s an intensive course in current requirements covering East and South East Asia, Australia and New Zealand. Register before January 31 for a $495 saving on the full rate.