🌍 Looking to expand your business globally with medical devices or IVD products? 🚀 Here’s what you need to know about the Free Sale Certificate (FSC)
A Free Sale Certificate (FSC) is a crucial document [...]
Regulatory Alignment Between the EU and Switzerland in In Vitro Diagnostic Medical Devices
On August 14, 2024, Swissmedic, Switzerland's regulatory authority for [...]
August 6th, Swissmedic is rolling out key changes for registration and modification in the CHRN
🔗 New Process: All registration applications and modifications must [...]
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 [...]
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 [...]
New Registration Process for Economic Operators in Switzerland: Key Dates You Can’t Miss!
Exciting news for all manufacturers, authorized representatives, and importers [...]
New Summary of fees and charges to applications submitted to the TGA
We are pleased to inform you that the Therapeutic [...]
Key Updates in Regulation (EU) 2024/1860: Implications for the Medical Device Industry
The new regulation brings significant changes that will impact [...]
Important Notice for Companies with Medical Devices in the European Market.
Attention to all companies with products regulated under Directive [...]
