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 safety [...]
19 03 2025
19 03 2025
19 03 2025
19 03 2025
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 October [...]
18 02 2025
18 02 2025
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 steps [...]
18 02 2025
18 02 2025
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 published [...]
18 02 2025
18 02 2025
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 patient [...]
22 01 2025
22 01 2025
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 Commission [...]
22 01 2025
22 01 2025
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 (MHRA) [...]
22 01 2025
22 01 2025
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 US [...]
18 12 2024
18 12 2024
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 for [...]
18 12 2024
18 12 2024
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 update [...]
