IMDRF's 29th Session Launches New AI and IVD Working Groups: What It Signals for Thai FDA

The 29th IMDRF Management Committee Meeting convened in Singapore from March 9 to 13, 2026, hosted by the Health Sciences Authority (HSA), and its agenda tells you a good deal about where global device regulation is heading over the next few years. Two new working groups came out of the session, one on AI/ML-enabled medical devices and one on clinical evidence for in vitro diagnostics, and both are directly relevant to how Thai FDA will regulate these product categories once the resulting guidance lands.

What Came Out of the 29th Session

The AI/ML working group will spend the next twelve to eighteen months developing principles covering algorithmic transparency, performance monitoring, and how regulators should treat AI systems that keep learning after deployment. The IVD working group is tasked with producing harmonized guidance on the clinical evidence, meaning the data standards and study designs, that regulators expect to see in IVD pre-market submissions. The session also formally recognized IMDRF/GRRP WG/N89, the Regulatory Reliance Playbook published the previous month, as a flagship deliverable in IMDRF's broader harmonization agenda. Taken together, the agenda marks a shift in IMDRF's own priorities, away from foundational classification and documentation frameworks and toward the technology categories, AI/ML devices and advanced IVDs, that pose the hardest regulatory questions member authorities currently face. Meeting materials are published directly by IMDRF: IMDRF 29th Management Committee Meeting, Singapore, March 2026.

The Thailand Angle

Thai FDA is a full IMDRF member and has a track record of folding IMDRF technical documents into its own guidance within one to two years of publication. The new AI/ML working group sits squarely on top of Thai FDA's existing SaMD regulatory framework, which already references international standards. Once the forthcoming AI/ML principles document is finalized, expect Thai FDA to incorporate it into its pre-market SaMD requirements, which makes tracking this working group's output a genuine leading indicator for companies developing or planning to register AI-enabled devices here.

The IVD clinical evidence working group matters just as much, arguably more, given the size of Thailand's IVD market: diagnostic reagents, blood glucose monitoring systems, infectious disease point-of-care tests, and increasingly sophisticated molecular diagnostics. Current Thai FDA expectations around IVD clinical data are not always clearly specified, which has left companies preparing Class C and D IVD registrations negotiating data requirements case by case. A harmonized IMDRF framework, once Thai FDA adopts it, would give companies far more certainty about the type, volume, and quality of clinical evidence a given IVD class actually needs.

What the session's agenda signals beyond the individual working groups is that IMDRF now treats regulatory reliance, AI device oversight, and IVD evidence standards as connected priorities rather than separate tracks. For any device company operating across ASEAN, that is worth internalizing: the architecture being built through IMDRF is going to shape not just individual country rules but the multi-market registration strategy companies use to enter and stay in the region.

Positioning Now, Ahead of Formal Adoption

IMDRF working groups typically publish draft documents for public comment before anything is finalized, so building IMDRF publication monitoring into your own regulatory intelligence process is worth doing now rather than waiting for a Thai FDA notification to surface the change secondhand. When the AI/ML draft principles document is released for comment, it will give device companies their earliest concrete look at the framework Thai FDA will eventually adopt, and the comment period is a genuine opportunity to influence the final language before it hardens into policy.

In the meantime, Thai FDA's existing SaMD classification guidance already applies to AI-enabled devices today, so reviewing your current or planned AI device registrations against that current framework is worth doing before the IMDRF principles document is even finalized. Devices treated as non-SaMD today, but that rely on AI/ML for clinical decision support, may need reclassification as the standards evolve. For IVD companies, the smarter move is to build clinical evidence packages to international standards now, ahead of Thai FDA formally adopting the IMDRF framework, since applications that already meet the coming harmonized standard will be far better positioned when Thai FDA's requirements catch up. Given that IMDRF guidance typically reaches national implementation twelve to thirty-six months after publication, the realistic window before Thai FDA acts on the most complex elements here is probably two to four years, which is exactly the amount of lead time worth using now to review your ASEAN registration portfolio and flag which devices would benefit most from a harmonized framework once it arrives.

DeeMED Consulting tracks IMDRF developments precisely so our clients see where Thai FDA requirements are heading before a new notification forces a reactive scramble. If you are developing AI-enabled devices or IVDs for the Thai market, our device classification services can help you assess your current classification against where these standards are moving.