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 [...]
Switzerland: UDI Module Activated and Requirements for Procedure Packs
Translated with AI Following the non-extension of the Mutual Recognition Agreement (MRA) with the European Union on May 26, [...]
Mexico Opens the Door: Shortened Registration for Medical Devices With International Approval
Mexico strengthens its commitment to simplify access to the Medical Devices market. With the publication of Acuerdo nel Diario Oficial [...]
Medical Device Apps: Who Is Responsible? MDCG Guide 2025-4 Provides Clarity
In the field of digital health, Medical Device Software (MDSW) apps are increasingly popular, used by patients and healthcare professionals [...]
Regulation (EU) 2025/1234 Extends eIFUs to All Devices for Professional Use
Instructions for Use (IFU) are a key component of medical device labelling in the European Union, essential for product safety [...]
Vietnam: End of Derogations for Import Licences as of July 1, 2025
The medical device sector in Vietnam has been the focus of significant regulatory reform in recent years. Decree No. 98/2021/ND-CP, [...]
The UDI System for Medical Devices in Australia: News and Key Deadlines
March 24, 2025, marks a milestone for the medical device industry in Australia: on this date, the Unique Identification [...]
