Regulatory monitoring
Medical device regulatory news
Texts published by official authorities and institutions over the last 60 days, grouped by topic. Every line links straight to the authority’s text.
Updated 22 October 2026 · 117 official texts
Software, AI and cybersecurity
- Thailand - FDA: Promotion of AI and Robotics in Healthcare - September 2026
Thai FDA — Thaïlande
In vitro diagnostics (IVDR)
ISO, IEC and harmonised standards
- ISO 28399:2026 - External Tooth Bleaching Products
ISO Normes DM
United States (FDA)
- FDA Class II Classification of Over-the-Counter Infant Pulse Oximeter
FDA Medical Devices
- FDA Guidance on the Electronic Submission Model for PMAs (draft)
FDA Medical Devices
- Pre-market Notification Exemption for Radiology Aids - FDA
FDA Medical Devices
- Microbial Reduction Device in Room: FDA Classification as Class II
FDA Medical Devices
- Classification of a Surgical Assistance Device for ENT Surgery by the FDA
FDA Medical Devices
- Vaginal Hydrogel Delivery System - Final FDA Regulation, 21 CFR 892
FDA Medical Devices
France: ANSM, HAS, Légifrance
- HAS Opinion 2026-0058/AC/SED on the Exceptional Coverage of the SAPIEN M3 Mitral Bioprosthesis
HAS — Haute Autorité de Santé
- HAS: CNEDiMTS Opinion on SOMNODENT FLEX
HAS — Haute Autorité de Santé
European Union: MDR, MDCG, Commission
- [Commission] Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies
Commission Européenne — DG SANTE DM
Other European authorities
- TEST FRAMEWORK FR RRN
AFMPS — Belgique
- Summary of Safety Notifications in Romania - September 2026
ANMDMR — Roumanie
- Exceptional Swissmedic Meeting on GMP Compliance of Foreign Manufacturers
Swissmedic — Suisse
- Infarmed Newsletter - Latest Edition
INFARMED — Portugal
- Infarmed Releases Indicators for August 2026
INFARMED — Portugal
- AEMPS: Labeling Error of Silver Graft Vascular Prostheses
AEMPS — Espagne
- RF Safety Considerations for Wireless CTG Monitoring Systems
MHRA — Royaume-Uni
- ElViS 2.0: transition of the electronic vigilance system to E2B(R3) format
Swissmedic — Suisse
- swissdamed Webinar 10 November 2026
Swissmedic — Suisse
- 1 September 2026 – New: FAQ on Swissmedic Fees Ordinance
Swissmedic — Suisse
Authorities outside Europe
- Thailand - Labeling and Claims for Adult Diapers: Pre-Submission Checks
Thai FDA — Thaïlande
- Thailand - Newsletter No. 12 September 2026 - Medical Device Regulation
Thai FDA — Thaïlande
- Thailand - Pre-registration and Modification Training for Active Medical Devices
Thai FDA — Thaïlande
- [Thailand] E-newsletter No. 11 for July 2026
Thai FDA — Thaïlande
- Thailand - Launch of a New Clinical Trial Management System for Medical Devices
Thai FDA — Thaïlande
How this page is built
- Only official authorities and institutions are kept (European Commission, MDCG, EUR-Lex, ANSM, FDA, ISO…), with a direct link to their text.
- Notices targeting a single manufacturer’s product (recalls, enforcement, approvals) are left out.
- Texts appear here 48 hours after publication. Subscribers receive them at each collection, filtered on their devices.
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