Swiss Authorised Representative (CH-REP)

One of our aims here at Shiro is to help medical device and MedTech companies comply with EU, Swiss and UK regulations. With this in mind, we wanted to ensure you knew of the upcoming deadline to appoint a CH-REP for Class I and system/procedure pack updates for medical devices. We notified you about the …

Important Regulatory Update: Class I Medical Devices and CH-REP Requirements Deadline Read More »

Switzerland is one of Europe’s largest medical device markets and home to many leading manufacturers. With a highly developed healthcare system and a reputation for quality, Swiss medical device buyers are known for their discerning taste and high standards. Selling medical devices in Switzerland requires a deep understanding of the country’s regulatory landscape and a …

Selling Your Medical Device in Switzerland: Best Practices and Regulatory Compliance Read More »