510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance
What happens when you intend to transfer or sell a 510(k) authorisation to another holder? The new FDA draft guidance [...]
SAHPRA Joins MDSAP as an Affiliate Member: New Opportunities for MD Manufacturers in South Africa
In April 2025, the South African Health Products Regulatory Authority (SAHPRA) announced, with an official press release, its membership as [...]
News on South Korea’s K-GMP Regulations for Medical Devices and IVDs
With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea [...]
EU: New Harmonised Standards for Medical Devices
The European Commission has recently updated the list of harmonised standards to support compliance with the MDR(EU) Regulations 2017/745 (EU) [...]
European Health Data Space Regulation (EHDS): New Obligations for Medical Device Manufacturers
With the adoption of Regulation (EU) 2025/327 the European Union has officially established the European Health Data Space (EHDS), introducing [...]
Update of MDCG Guidance 2020-16 on the Classification of IVDs in the EU
On March 18, 2025, the Commission's Directorate-General for Health and Food Safety published Revision 4 of MDCG Guidance 2020-16, [...]
Terminology for Adverse Events in Medical Devices: IMDRF Update, March 2025
The IMDRF (International Medical Device Regulators Forum), an international cooperation body promoting the harmonisation of medical device regulation, published on [...]
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) [...]
Switzerland: Updates on Safety Measures and IVD Labelling
Switzerland: Updates on Safety Measures and IVD Labelling The regulatory environment in Switzerland is evolving to strengthen both the [...]
Italy: First NIS2 Fulfilments for Cybersecurity
Italy: First NIS2 Fulfilments for Cybersecurity The Legislative Decree 138/2024 , which was published in the Official Journal on [...]
IVDR Transition: Australia and Switzerland Align With the European Union
IVDR Transition: Australia and Switzerland Align With the European Union In recent years, both Australia and Switzerland have taken significant [...]
FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs
FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs On January 6, 2025, the FDA [...]
Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2
Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2 Vigilance on Medical Devices is a key activity to ensure [...]
EU Commission: Call for Contributions for the Assessment of the Regulatory Framework
The Commission Launches a Public Consultation and a Call for Input for the Assessment of the Regulatory Environment The European [...]
United Kingdom: Post-Market Surveillance Guidelines
UK: Guidelines for Post-market Surveillance of Medical Devices Published On January 15, 2025, the Medicines and Healthcare products Regulatory Agency [...]
FDA: Guidelines for Managing Medical Devices with AI
USA: FDA Publishes Draft Guidelines for the Development and Management of Medical Devices With Artificial Intelligence In January 2025, the [...]
Hong Kong: New Rules for Renewal Applications
19/12/2024 As of January 1, 2025, the Hong Kong Medical Device Division (MDD) is applying new rules for renewal applications [...]
Philippines: New Licensing Order for Health Care Companies
19/12/2024 On November 22, 2024, the Philippine Food and Drug Administration (FDA) issued the new Administrative Order No. 2024-0015 to [...]
