News

UK: Guidelines for Post-market Surveillance of Medical Devices Published On January 15, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) [...]

USA: FDA Publishes Draft Guidelines for the Development and Management of Medical Devices With Artificial Intelligence In January 2025, the US [...]

19/12/2024 As of January 1, 2025, the Hong Kong Medical Device Division (MDD) is applying new rules for renewal applications for [...]

19/12/2024 On November 22, 2024, the Philippine Food and Drug Administration (FDA) issued the new Administrative Order No. 2024-0015 to update [...]

19/12/2024 On November 26, 2024, the Medical Device Coordination Group (MDCG) published MDCG Guide 2024-14, a key document for contact lens [...]

22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation of [...]

22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority (SFDA) [...]

22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled [...]

18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - Guidance [...]

18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a voluntary [...]