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 [...]
MDCG 2024-14: Guidance on the Implementation of the UDI-DI Master for Contact Lenses
19/12/2024 On November 26, 2024, the Medical Device Coordination Group (MDCG) published MDCG Guide 2024-14, a key document for contact [...]
Shortages of Medical Devices: Questions and Answers on Article 10a of Regulation (EU) 2024/1860
22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation [...]
Innovative Medical Devices in Saudi Arabia: Updated SFDA MDS – G002 Guidance. Version 3.0 (2024)
22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority [...]
MDCG Guideline 2022-5 Rev.1 Update: Clarification of Borderline Products between Medical Devices and Medicinal Products
22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, [...]
Published MDCG Guidance 2024-11 for IVD Qualification
18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - [...]
ASCA Programme Updates: Three Draft FDA Guidelines
18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a [...]
CDRH Expands Voluntary Pilot Tap (Total Product Life Cycle Advisory Programme)
18/10/2024 On October 1, 2024, the FDA's Centre for Devices and Radiological Health (CDRH) in the US announced that devices [...]
Australia: Updated Checklist of Essential Principles for Medical Devices
In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the [...]
FDA: eSTAR Implementation Date Announced for de Novo Applications in Updated Guidance
The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled 'Electronic Submission [...]
Amendments to the Recall Regulation and MDEL in Canada: SOR 2024-136
On July 3, 2024, Regulation SOR 2024-136 was published in the Canada Gazette, an update that makes significant changes to [...]
FDA: Published Fees for Fiscal Year 2025
On July 31, 2024, the U.S. Food and Drug Administration (FDA) officially announced in the Federal Register the new medical [...]
EU: The Artificial Intelligence Act (AIA) included in the EU Official Journal
The European Commission has made available the final text of the Artificial Intelligence Act (AIA), the world's first comprehensive regulatory [...]
