What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
Meditrial Editorial Team2026-08-31T13:49:28+00:00August 28th, 2026|Categories: Clinical Trial, Meditrial, Regulatory, Switzerland|
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
k.janecek2024-02-29T14:19:54+00:00March 8th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, Medical Devices, MedTech, Regulatory Affairs, Switzerland|
The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to uniquely identify them. Meditrial successfully represents many [...]
k.janecek2024-02-29T14:19:37+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, MedTech, Regulatory, Regulatory Affairs, Switzerland|
Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the medical devices database will be similar to EUDAMED. [...]
k.janecek2024-02-29T14:30:34+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: Clinical Trial, Europe, MDR, Regulatory, Switzerland|
Additional provisions have been adopted for the new Medical Device Regulation (MedDO) in Switzerland and enter into force on 26 May 2021. This action was taken to offset the negative consequences of the absence of the MRA update and [...]
Meditrial Editorial Team2024-02-29T14:31:01+00:00March 24th, 2021|Categories: Clinical Trial, Europe, MDR, Switzerland|Tags: Clinical Trial, Europe, MDCG, Switzerland|
Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials in Switzerland. Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals and local [...]
Meditrial Editorial Team2024-02-29T15:06:23+00:00November 13th, 2020|Categories: Regulatory, Switzerland, UK|Tags: Clinical Trial, Europe, Regulatory, Switzerland, UK|
The UK’s Department for International Trade in Switzerland announced a virtual information session specially for Swiss medtech and medical device companies, to give an update on latest policy developments and regulatory guidance. The event will take place online on [...]
k.janecek2024-02-29T10:16:35+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: Europe, Expert, Innovation, Regulatory, Switzerland, Venturelab|
Dr. Monica Tocchi, CMO and Founder of Meditrial joined the Innosuisse Start-up Training program designed by Venturelab, as a member of their Expert panel. The panel is composed of successful founders, leading academic and industry partners that bring the [...]
k.janecek2024-02-01T14:12:57+00:00May 27th, 2020|Categories: Europe, Innovation, Switzerland|Tags: Innovation, Switzerland|
On 4th June 2020, Dr. Monica Tocchi, Founder and CMO of Meditrial will hold a virtual training hosted by Venturelab – a swiss startup training program commissioned by Innosuisse . This intensive course entitled “Win KOLs and work with partners” is [...]
k.janecek2024-02-29T13:47:50+00:00May 18th, 2020|Categories: Covid-19, Switzerland|Tags: Covid-19, Europe, Innovation, Switzerland|
Meditrial is happy to announce the reopening of our Swiss Office as of today, May 18th. We have been working remotely during the last two months, in order to continue to provide support and services to our customers all [...]
Meditrial Editorial Team2024-02-29T14:26:41+00:00April 16th, 2020|Categories: Clinical Trial, Covid-19, Europe, Switzerland|Tags: Clinical Trial, Covid-19, Europe, Switzerland|
The Swiss Federal Council issues a new regulation allowing marketing of devices that have not undergone a conformity assessment procedure. This will not exempt the manufacturer from proving performance of the device and essential requirement fulfilment. This exception is [...]
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