medicines-medical devices-regulatory affairs
Last updated: 15 September 2025 To view updates, click on the ‘+’ sign below. What is Decentralised Manufacturing? Point of Care (POC) and Modular Manufacture (MM) are collectively described as Decentralised Manufacture (DM). Which product types are included as POC…
Last updated: 14 August 2025 To view updates, click on the ‘+’ sign below. PLM Portal FHIR XML version upgrade The PLM portal FHIR XML version was updated to 2.2.3. The new version introduces the following changes: • There’s a new…
Last updated: 15 July 2026 To view updates, click on the ‘+’ sign below. The African Medicines Agency’s (AMA) long journey towards harmonization started in 2009 with the establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH) and the involvement…
Last updated: 26 October 2025 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2025 (Medical Devices) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final This guidance is applicable to devices with…
Last updated: 1 July 2025 To view updates, click on the link below: Switzerland is considered a leading research locations for clinical trials. What is at the core of the fast-track procedure? At the core of the fast-track procedure will…
Last updated: 28 June 2025 To see updates, click on the ‘+’ sign below Anyone who has worked on licensing medicinal products in the AsiaPac, LatAm and MEA regions will quite likely have encountered the requirement to obtain a legalised Certificate…
Last updated: 23 June 2025 To view updates, click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 20-21 May 2025 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of…
Date Guidance No About the guidance 19 Jun 2025 MDCG 2025-6 FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025) This document provides a first set of…
Last updated: 20 June 2025 To view updates, click o the ‘+’ sign below. The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023. About the Innovative Devices Access Pathway (IDAP) The aim of IDAP is to enable and…
Last updated: 11 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide basic information about patents, Supplementary Protections Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers. The information provided is…
Last updated on 4 June 2026 See history of updates below. This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on…