Freyr (CH-Rep Services)

Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers seeking to market their products in Switzerland. They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.

Freyr (CH-Rep Services) is a specialized provider of Swiss Authorized Representative (CH-REP) services, essential for medical device manufacturers looking to access the Swiss market. They offer comprehensive regulatory support, including appointing a CH-REP, representing devices in Switzerland, and liaising directly with Swissmedic on your behalf. Their services ensure your medical devices meet all necessary compliance requirements for registration and marketing. With a strong understanding of Swissmedic's regulations, including recent amendments to the Medical Devices Ordinance (MedDO), Freyr helps navigate the complexities of market access. They provide guidance on unique identification numbers (CHRN), reporting of incidents and field safety corrective actions (FSCA), and clinical trial requirements. Freyr's expertise extends to reviewing technical files for compliance and ensuring your labeling meets Swiss standards. Freyr offers a free 30-minute consultation to discuss your specific needs and provides step-by-step guidance throughout the process. Their commitment is to facilitate a smooth and compliant entry into the Swiss market for your medical and in-vitro devices.

About

**Who they are**
Freyr (CH-Rep Services) is a provider specializing in Swiss Authorized Representative (CH-REP) services for medical device manufacturers. They focus on ensuring compliance with Swiss regulations.

**Expertise & scope**
* Expert Swiss Authorized Representative (CH-REP) services
* Regulatory support for medical device manufacturers
* Liaison with Swissmedic
* Ensuring compliance with Swiss regulations
* Support for placing products on the Swiss market
* Guidance on Swissmedic's new medical device regulations, including MedDO amendments
* Assistance with Unique Identification Number (CHRN) assignment
* Reporting of incidents and Field Safety Corrective Actions (FSCA) to Swissmedic
* Guidance on clinical trials of medical devices under Swiss regulations
* Leveraging the AI-first regulatory platform, freya fusion, for compliance needs

**Reputation / proof points**
* Offers services across Switzerland (CH)
* Operates with a global presence, including offices in USA, UK, EU, and India, with specific locations mentioned in Princeton NJ, USA; Ajman, UAE; Toronto, Canada; Mexico City, Mexico; Singapore; Penang, Malaysia; and Gauteng, South Africa.
* Provides regulatory support in English, German, and French.

Additional information

Freyr (CH-Rep Services) assists manufacturers in navigating Switzerland's specific regulatory landscape, particularly in light of recent amendments to the Medical Devices Ordinance (MedDO). They emphasize the importance of timely registration with Swissmedic to obtain a Swiss Single Registration Number (CHRN) within three months of placing the first product on the market, thereby avoiding supply chain disruptions. The company also highlights its role in managing incident reporting and Field Safety Corrective Actions (FSCA) to Swissmedic, ensuring ongoing market surveillance and patient safety. Their AI-first platform, freya fusion, is designed to manage the entire regulatory lifecycle, from initial registrations to post-approval management.

Key Highlights

  • Provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers. Source
    “Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers”
  • Offers regulatory support and liaises with Swissmedic to ensure compliance with Swiss regulations. Source
    “They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.”
  • Assists with obtaining the Swiss Single Registration Number (CHRN) and reporting incidents to Swissmedic. Source
    “Upon request, Swissmedic assigns the Swiss Single Registration Number (CHRN) to Swiss manufacturers, authorized representatives and importers.”
  • Utilizes the AI-first regulatory platform, freya fusion, for managing the regulatory lifecycle. Source
    “freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”

Certifications & Trust Signals

  • Established presence with multiple global offices, including USA, UK, EU, and India. Source
    “With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”
  • Supports clients in multiple languages including English, German, and French. Source
    “Languages: English, German, French”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking Swiss Authorized Representation
  • Companies needing to comply with Swissmedic regulations
  • Businesses requiring assistance with CHRN registration and reporting
How engagement typically works
  • End-to-end regulatory solutions
  • Leveraging AI/ML-driven platforms
  • Direct liaison with Swissmedic
Typical deliverables
  • CH-REP appointment
  • Regulatory strategy and insights
  • Dossier authoring
  • Post-approval/lifecycle management
  • Country-specific regulatory services
  • Vigilance reporting support
Good to know
  • Best when requiring specific expertise in Swiss medical device regulations.
HQ: Princeton, USA
Languages: English, German, French
Timezones: Europe/Zurich
Status: listed

Services & Capabilities

Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes

Jurisdictions: CH
Countries: CH
Industries: Medical devices, IVD
Portfolio: 100+
Onboarding time: 1–5 days
Pricing model: Retainer
Starting from: CHF 3,500
Included services: Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported: Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact: Yes
Labeling Support: Yes
Can Be Named On Label: Yes
Vigilance Contact Support: Yes

Additional ch_rep Details

Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Requires registration with Swissmedic within three (03) months of placing the first product on the Swiss market.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Supports MDR
true
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Swiss Entity Canton Or Region
CH
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