medicines-medical devices-regulatory affairs
Medical Devices (MD) registration When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period? The registration of devices, systems, and procedure packs according to Art.…
Last updated: 9 March 2026 To view updates, please click on the ‘+’ sign below: Date Update(s) to the position paper 9 Mar 2026 The Annexes have been revised to reflect the updated recommendation paper of the European Commission’s Directorate-General…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
In this post, information is provided on the following updated guidance documents: Changes to the guidance document Time limits for authorisation applications Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active…
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…
Information on changes to the following guidance documents are provided below: Changes to the Guidance document Time limits for authorisation applications The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for…
The table below details changes to five guidance documents (listed in column 1 below) for the authorisation of human medicinal products. Updated guidance document Document (plus form where applicable) What the document concerns Changes to the document Sections of the…
Last updated: 14 November 2023 See all updates at the end of this post. Swissmedic has published guidance on the requirement for Swiss authorised representative (CH-REP) for medical devices. Definition of a Swiss authorised representative Natural or legal person in…
This post is an attempt to provide basic information on the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) and the MAGHP Light procedures. The MAGHP and MAGHP Light Procedures are part of Swissmedic’s engagement in development cooperation, in accordance…
What are the implications of the new Medical Devices Regulation (EU) 2017/745 (MDR) becoming applicable, for Switzerland? Until 26 May 2021, Switzerland had been participating in the European Union (EU) internal market for medical devices through a specific chapter of…