MDSAP: Audit Approach Version 010 Released, what changes
On February 2, 2026, version 010 of the MDSAP AU P0002 – Audit Approach manual was released. This update comes nearly [...]
26 02 2026
26 02 2026
24 02 2026
24 02 2026
Compliance Program 7382.850: what to expect from the new FDA inspections
On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves as [...]
17 02 2026
17 02 2026
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) launched [...]
29 01 2026
29 01 2026
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 the [...]
26 01 2026
26 01 2026
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 reference [...]
14 01 2026
14 01 2026
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 European [...]
18 12 2025
18 12 2025
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 Essential [...]
18 12 2025
18 12 2025
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)”. The [...]
17 12 2025
17 12 2025
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 six [...]
25 11 2025
25 11 2025
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 (GMP) [...]
