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Freyr CH-REP Services for Foreign Manufacturers

Are you a foreign manufacturer exporting devices to Switzerland? Looking for a CH-REP?
Freyr is a trusted CH-REP partner for global device manufacturers.

Freyr CH-REP services include:

  • Representing your device in Switzerland
  • Liaising with Swissmedic on your behalf
  • Registration of your devices with Swissmedic
  • 30 minutes pre-purchase free consultation
  • Review of technical file for Swissmedic compliance
  • Freyr name on labeling

What More?

 

Quarterly reports on CH-REP services

Heads up on Swiss medic updates

 
 

Qualified PRRC acting as your CH-REP

Discounted pricing on multi-year and multi-product contracts

 

Why Freyr?

Established
CH-REP entity

Registered with the Swissmedic

Reliable partner for Europe region

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With a few simple steps setup end-to-end Regulatory support for registering and marketing your medical and in-vitro devices in Switzerland

 

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Swiss Authorized Representative
Frequently Asked Questions

The Swissmedic’s Medical Device Ordinance (MedDO) requires all foreign (non-Swiss) device manufacturers to appoint a Swiss Authorized Representative (Swiss AR) to place device products on the Switzerland market. The Swiss AR must represent a foreign manufacturer concerning the responsibilities specified in MedDO.
Switzerland has revised its Therapeutic Products Act (TPA) and Medical Device Ordinance (MedDO) and aligned them with the European Medical Device Regulation (MDR), establishing legal equality with the EU MDR & IVDR. According to article 51 of the Medical Device Ordinance, a foreign manufacturer can only place their products on the Swiss market when they have delegated a person based in Switzerland as its Authorized Representative (Swiss AR).
A Swiss AR must be a natural or legal person based in Switzerland and must have received and accepted a written mandate from the manufacturer.
Foreign manufacturers may choose to designate multiple Swiss ARs for their device portfolio. However, there shall be only one Swiss AR for all devices of the same generic device group, and for different generic groups, multiple Swiss ARs can be appointed.

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