Noticias y novedades
Regulatory Alignment Between the EU and Switzerland in In Vitro Diagnostic Medical Devices
On August 14, 2024, Swissmedic, Switzerland's regulatory authority for therapeutic products, announced its decision to implement the recent amendment to the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR). This move aims to ensure the stability of in [...]
August 6th, Swissmedic is rolling out key changes for registration and modification in the CHRN
🔗 New Process: All registration applications and modifications must now be submitted exclusively through the Swissdamed platform as of 6th Agust 2024. This marks a major step forward in the digitalization and regulation of the sector in Switzerland. 🕒 [...]
CMC MEDICAL DEVICES & DRUGS, S.L. Obtains ISO 13485:2016/A11:2021 Certification, Reaffirming Its Commitment to Quality and Safety in the Medical Industry
CMC MEDICAL DEVICES & DRUGS, S.L., a company dedicated to regulatory affairs and representation of medical devices, is pleased to announce that it has obtained the ISO 13485:2016/A11:2021 certification, an internationally recognized standard that defines the requirements for providing [...]
New Artificial Intelligence Law Comes Into Force Today, August 1, 2024: Key Points and Focus on High-Risk Devices
The European Parliament and the Council of the European Union have approved Regulation (EU) 2024/1689, establishing a uniform legal framework for the development, commercialization, and use of artificial intelligence (AI) systems across the European Union. The primary aim of [...]
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. [...]
