Noticias y novedades
New Registration Process for Economic Operators in Switzerland: Key Dates You Can’t Miss!
Exciting news for all manufacturers, authorized representatives, and importers in Switzerland! Swissmedic is rolling out a new registration system via the swissdamed Actors module starting August 2024. Here’s what you need to know: 📅 Key Dates: 🗓️ Until July [...]
New Summary of fees and charges to applications submitted to the TGA
We are pleased to inform you that the Therapeutic Goods Administration (TGA) has implemented a significant update to its fees, which came into effect on July 1, 2024. This update is part of the TGA's ongoing commitment to recover [...]
Important Notice for Companies with Medical Devices in the European Market. ( Cloned )
Attention to all companies with products regulated under Directive 98/79/EC: It is crucial to be aware of the latest regulatory updates affecting the validity of certificates issued by notified bodies. Effective from July 9, 2024, the following changes will come [...]
Key Updates in Regulation (EU) 2024/1860: Implications for the Medical Device Industry
The new regulation brings significant changes that will impact both manufacturers and healthcare professionals. Here are the key highlights: Gradual Implementation of Eudamed: The Eudamed database, essential for transparency and traceability of medical devices, will be gradually implemented. This [...]
The First Module of the swissdamed Medical Devices Database Launches Online in August
We are pleased to announce that the first module of the swissdamed medical devices database will be available online starting August 2024. This significant milestone represents a major advancement for the regulation and transparency of medical devices in Switzerland. [...]
CMC Consulting Group celebrates tenth anniversary of CMC Medical Devices with a new corporate image
CMC Consulting Group, a leading holding company in regulatory affairs and medical devices, celebrates the tenth anniversary of its parent company, CMC Medical Devices, with the presentation of a new corporate image that reflects its evolution and growth. With [...]
NEW Notified Bodies obtained the MDR audit qualification
Two new authorizations have been added to the EU MDR, bringing the total number of MDR Notified Bodies to 48! From the 9th till the 10th of May 2024, MTIC InterCert S.r.l. and Kiwa Belgelendirme Hizmetleri A.S. obtained the MDR [...]
Revision of MedDO and IvDO
The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose (media release dated 29 September 2023). Switzerland has adapted its MedDO for these products in line with the [...]
How long are the transition periods for IVDR?
The length of the new deadlines depends on the future IVDR risk class and whether a notified body has already been involved under IVDD. Interestingly, according to the current proposal, the EU has moved the original cut-off date from May [...]
