Switzerland Medical Device Regulations

Switzerland Medical Device Regulations - www.omcmedical.com

Switzerland Medical Device Regulations

Switzerland Market Situation

  1. Administrative cost of CHF 114 million initially
  2. CHF 75 million annually
  3. Cost represent 2% and 1.4% of total export volume (CHF 5.2 billion) to the
    EU

Switzerland Market Situation – Downside

Switzerland- Medical Device Regulations

Medical devices are regulated by : Swiss Agency for Therapeutic
Product

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

Role of Swiss AR’s PRRC

Liability of a Swiss AR

Manufacturer Responsibility

Notifications

UDI- CHRN

Update for Manufacturers in EU & Swiss

For manufacturer outside Switzerland:

Need to appoint Swiss AR, update the labelling for MDR products & follow
third country requirements

Timeline to appoint swiss AR:

Swiss Manufacturer exporting to EU:

How we assist you with this process?

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