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Switzerland Medical Device Regulations

Switzerland Authorised Representative

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

Current Switzerland Market Situation

  • As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement(MRA)
  • No barrier free access to the EU internal market.
  • Swiss has been downgraded to the third country.
  • Swiss manufactures has stricter requirements when exporting their medical devices to the EU.

Manufacturer Responsibility

Manufacturers outside Swiss

Swiss Authorised Representative

Update for Manufacturers in EU & Swiss

EU Manufacturer Exporting to Swiss

Swiss Manufacturer Exporting to EU

Contact us for free consultation: info@omcmedical.co.uk

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