Switzerland AR

Switzerland Medical Device Regulations

Medical devices are regulated: Swiss Agency for Therapeutic Product (Swissmedic)


Swiss Agency for Therapeutic Product ( Swissmedic) - www.omcmedical.com

Current Switzerland Market Situation:

Manufacturer Responsibility

Manufacturers outside Swiss:

– Proxy to the foreign manufacturer
– Responsible for product safety 
– Liable for product defects
– Contact person for Swiss authorities
– Can be legal entity or as a natural person
– Must have access to PRRC

Swiss Authorised Representative

Update for Manufacturers in EU & Swiss:

EU Manufacturer Exporting to Swiss:

Swiss Manufacturer Exporting to EU:

How we assist you with this process?

Why Choose Us  

Contact us for free consultation: [email protected]