medicines-medical devices-regulatory affairs
Last updated: 6 August 2024 This post is an attempt to provide basic information about Swissdamed and progress with its availability. To see the updates, click on ‘+’ sign below. About Swissdamed Swissdamed is Swissmedic’s new database for registering economic…
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…
In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the sartans class. Trace amounts of nitrosamine impurities were also subsequently detected in other medicinal products.Swissmedic evaluates and oversees…
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…
Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations. EU MDR amendment of 20 March 2023 Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional…
Between Between August and December 2022, Swissmedic launched a focus campaign to investigate how the new regulation was being implemented with regard to Class I Medical devices. It reviewed declarations of conformity, evidence that Swissmedic had been notified of the…
Last updated: 22 December 2022 Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products from version 1.1 to version 2.0 of 15 December 2022. According to Swissmedic, revisions and clarifications have been added where necessary.…
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…