IMDRF Publishes Materials from 30th Management Committee Meeting in Singapore
The International Medical Device Regulators Forum (IMDRF) has published materials from its 30th Management Committee Meeting, held in Singapore from 14 to 18 September 2026 and hosted by the Health Sciences Authority (HSA). 1790658465641
The published materials cover a broad range of topics relevant to medical device regulators and industry, with a strong emphasis on digital health technologies, software, artificial intelligence, change management and cybersecurity.
Digital Health as a Central Theme
The first day of workshop sessions opened with a scene-setting session on the global regulatory landscape for digital health technology. 1790658465641
This was followed by dedicated sessions on:
software characterisation and risk categorisation;
AI governance and Good Machine Learning Practice;
Predetermined Change Control Plans;
cybersecurity. 1790658465641
The programme shows that software and AI-enabled medical technologies remain a major area of international regulatory coordination.
Software Characterisation and Risk Categorisation
One workshop session focused on “Software Characterization and Risk Categorization – From Guidance to Practice.”
Multiple presentation files were published for the session, indicating contributions from different participants or jurisdictions. 1790658465641
For medical device software developers, this topic is particularly relevant to how regulators define, classify and evaluate software-based medical technologies in practice.
AI Governance and GMLP
The meeting also included a dedicated session on AI Governance and Machine Learning Practices (GMLP).
Presentation materials were published for this session as part of the Day 1 workshop programme. 1790658465641
The inclusion of GMLP reflects the continuing international focus on how AI and machine learning should be developed, validated, monitored and governed across the medical device lifecycle.
Predetermined Change Control Plans
Another major workshop topic was Predetermined Change Control Plans (PCCPs).
Four presentation files were made available for this session. 1790658465641
PCCPs are increasingly important for software and AI-enabled medical devices because they provide a structured regulatory approach to certain anticipated post-market modifications.
Cybersecurity
Cybersecurity also featured as a standalone workshop session.
Three presentation files were published under this topic. 1790658465641
This reinforces cybersecurity as a core international regulatory priority for connected, software-driven and digitally enabled medical devices.
Regulatory Updates from IMDRF Management Committee Members
The meeting materials include jurisdictional updates from a wide range of IMDRF Management Committee members.
These include:
Australia — TGA;
Brazil — ANVISA;
Canada — Health Canada;
China — NMPA;
European Union — European Commission;
Japan — PMDA;
Russia — Ministry of Health;
Switzerland — Swissmedic;
Singapore — HSA;
United Kingdom — MHRA;
South Korea — MFDS;
United States — FDA. 1790658465641
These updates provide visibility into current regulatory developments across major medical device markets.
Official Observer Updates
The published meeting materials also include regulatory updates from IMDRF Official Observers:
Argentina — ANMAT;
Saudi Arabia — SFDA;
World Health Organization — WHO. 1790658465641
This expands the international scope of the meeting beyond Management Committee members.
Affiliate Member Updates
Several IMDRF Affiliate Members also provided jurisdictional updates, including:
Cuba — CECMED;
Paraguay — DINAVISA;
Tanzania — TMDA;
Israel — MTIIR. 1790658465641
These contributions support broader regulatory information exchange beyond the core IMDRF membership.
Regional Health Initiatives
The meeting resources also include updates from regional initiatives:
APEC RHSC;
SEARN. 1790658465641
This highlights the relationship between IMDRF activity and wider regional regulatory harmonisation initiatives.
Working Group Updates
A consolidated Working Group Updates document was also published. 1790658465641
IMDRF working groups are central to the development of harmonised regulatory approaches and technical documents across areas such as software, clinical evaluation, quality systems, cybersecurity and regulatory convergence.
Stakeholder Contributions
The meeting also included stakeholder updates from several industry organisations.
Materials were published from:
DITTA and GMTA;
IMDRF Industry Group;
APACMed;
Singapore Manufacturing Federation – Medical Technology Industry Group. 1790658465641
These contributions provide an industry perspective alongside regulator-led discussions.
Impact on Medical Device and Digital Health Stakeholders
For medical device manufacturers, software developers, AI companies, regulatory affairs teams and other stakeholders, the published meeting materials provide a useful overview of current international regulatory priorities.
Key areas to monitor include:
software characterisation;
risk categorisation;
AI governance;
Good Machine Learning Practice;
Predetermined Change Control Plans;
cybersecurity;
digital health regulatory convergence;
regulatory developments across major jurisdictions;
IMDRF working group activity;
industry-regulator engagement.
The strong focus on software, AI and cybersecurity suggests that international alignment around digital medical technologies continues to be a significant area of regulatory development.
