South Korea launches fast track pathway for innovative Medical Devices
On 26 January 2026, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) [...]
Regulation B.E. 2568 in Thailand: A Unified Framework for Medical Device Labeling
Translated with AI The regulatory framework for medical device labelling in Thailand reached a comprehensive synthesis with the publication of [...]
Clinical Decision Support Software: FDA Guidance Provides Clarity
Translated with AI The evolution of digital health has blurred the lines between IT tools and Medical Devices. A key [...]
MDR and IVDR Reform: the Commission’s Proposal for a Long-Awaited Simplification
Translated with AI With the publication of the proposal for a Regulation COM(2025) 1023 final of 16 December 2025, the [...]
TGA updates the guidance on Essential Principles for Medical Devices
Translated with AI On November 19, 2025, the Therapeutic Goods Administration (TGA) released the updated guidance "Complying with the [...]
Breakthrough Devices (BtX): New Opportunities for MedTech Innovation in Europe
Translated with AI On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on “Breakthrough Devices (BtX)”. [...]
EUDAMED obligation starts May 28, 2026: what to do now?
Translated with AI On November 27, 2025, the European Commission announced the full functionality of four out of the [...]
New GMPs in China: Evolution of the Quality System for Medical Devices
Translated with AI After eleven years, the National Medical Products Administration (NMPA) published the new edition of Good Manufacturing Practices [...]
Health Canada Launches Phase II Consultation to Modernize Medical Device Establishment Licences (MDEL)
Translated with AI On November 8, 2025, Health Canada (HC) launched a public consultation on the proposed modernization of the [...]
Spain Completes IVDR Alignment with Royal Decree 942/2025
Translated with AI On October 23, 2025, the Spanish Royal Decree No. 942/2025 was published in the Boletín Oficial [...]
Malaysia Joins MDSAP as an Affiliate Member: New Expansion Possibilities
Translated with AI Interesting incentives continue for medical device manufacturers interested in expanding into the Asian market. In September [...]
EU: Updated Borderline and Classification Manual for Medical Devices according to MDR and IVDR
Translated with AI In September 2025, the Borderline and Classification Working Group (BCWG), an advisory group established by the [...]
Great Britain: Greater Certainty with the Standard Model for Post-Market Surveillance Reports (PMSR)
Translated with AI On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published new guidelines and [...]
Regulatory Reliance in Asia: Malaysia-China and Malaysia-Singapore Accelerate Market Access
Translated with AI Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation [...]
Mexico: A Summer of Regulatory Overhaul
Translated with AI Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection [...]
EU: MDR Language Requirements Tables Updated
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for [...]
Medical Advertising in Italy: The New Guidelines
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical [...]
IVD Software Qualification: The Team-NB Guide
Translated with AI The Team-NB, the European association of Notified Bodies for Medical Devices, published the second version of its [...]
