Obelis
Obelis Group
Obelis is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles across the EU, UK, US, and Switzerland.
Obelis Group is a leading regulatory compliance specialist, dedicated to accelerating your market access worldwide. With extensive experience in the EU, UK, US, and Switzerland, Obelis provides expert guidance and comprehensive services for a wide range of industries, including Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles. We act as your Authorised Representative and Responsible Person, ensuring your products meet all local regulatory requirements. Our services encompass formula review, labelling compliance, claims verification, product registration, technical documentation management, and communication with regulatory authorities. Whether you are navigating the complexities of the EU General Product Safety Regulation (GPSR) or ensuring your toys meet stringent safety standards, Obelis offers tailored solutions. Obelis also provides specialized training programs to help your team master EU compliance requirements for cosmetics and medical devices. Our flexible training options, including in-house, online, and on-demand modules, empower your staff with the knowledge and tools needed for successful market entry and sustained compliance. Partner with Obelis to confidently bring your products to international markets while mitigating risks and building consumer trust.
About
**Who they are**
Obelis is a Swiss-based partner specializing in global regulatory compliance, with a focus on market access for various product categories in key regions including the EU, UK, US, and Switzerland. They offer comprehensive services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Mandatory designation of a Swiss-based Authorised Representative (CH-REP) for non-Swiss manufacturers since May 2022, following the end of mutual recognition with the EU.
* Expertise in Medical Devices (MD), In-vitro medical devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
* Services include acting as the Swiss Authorised Representative, product registration with Swissmedic, technical documentation preparation compliant with EU MDR and MedDO, and Swiss consultancy, legal, and training.
* Assistance with product registration via Swissmedic, as Switzerland does not have access to EUDAMED.
* Guidance on technical documentation requirements, including Post-Market Surveillance (PMS) plans and reports, and ensuring compliance with Annex II and III of the EU MDR.
* Support for appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law and EU MDR.
* Advising on labeling requirements and post-market vigilance obligations.
**Reputation / proof points**
* Over 32 years of regulatory expertise.
* Offices in Brussels, UK, USA, Canada, and Switzerland, enabling support across important markets.
Obelis is a Swiss-based partner specializing in global regulatory compliance, with a focus on market access for various product categories in key regions including the EU, UK, US, and Switzerland. They offer comprehensive services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Mandatory designation of a Swiss-based Authorised Representative (CH-REP) for non-Swiss manufacturers since May 2022, following the end of mutual recognition with the EU.
* Expertise in Medical Devices (MD), In-vitro medical devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
* Services include acting as the Swiss Authorised Representative, product registration with Swissmedic, technical documentation preparation compliant with EU MDR and MedDO, and Swiss consultancy, legal, and training.
* Assistance with product registration via Swissmedic, as Switzerland does not have access to EUDAMED.
* Guidance on technical documentation requirements, including Post-Market Surveillance (PMS) plans and reports, and ensuring compliance with Annex II and III of the EU MDR.
* Support for appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law and EU MDR.
* Advising on labeling requirements and post-market vigilance obligations.
**Reputation / proof points**
* Over 32 years of regulatory expertise.
* Offices in Brussels, UK, USA, Canada, and Switzerland, enabling support across important markets.
Additional information
Manufacturers seeking to place medical devices on the Swiss market must appoint a Swiss Authorised Representative (CH-REP) if they are not based in Switzerland. This role is critical following the end of mutual recognition with the EU for medical devices. Obelis facilitates this by assuming the CH-REP role, ensuring technical documentation is compliant with Swiss regulations (MedDO) and EU MDR, and managing product registration with Swissmedic. They emphasize the need for professionalism and qualifications at a level equivalent to EU IVDR standards for this role. For non-EU manufacturers without an existing EU Authorized Representative, appointing a Swiss Authorized Representative is an immediate requirement.
Key Highlights
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Mandatory Swiss Authorised Representative (CH-REP) services for non-Swiss manufacturers.
Source
“From 26 May 2022, it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative.”
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Expertise in Medical Devices (MD) and In-vitro medical devices (IVD) compliance.
Source
“Swiss Authorised Representative; Medical devices (MD); In-vitro medical devices (IVD);”
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Product registration services with Swissmedic for the Swiss market.
Source
“We register your devices with SwissMedic.”
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Technical documentation support aligned with EU MDR and Swiss MedDO.
Source
“Manufacturers must draw up and keep technical documentation that demonstrates that their products conform to the requirements of Annex II and III of the EU MDR.”
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Over 32 years of regulatory expertise.
Source
“Are you a manufacturer looking to lighten your regulatory load by taking advantage of our 32 years of regulatory expertise?”
Certifications & Trust Signals
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Offices in Brussels, UK, USA, Canada, and Switzerland.
Source
“With our headquarter office in Brussels and our offices in the UK, USA, Canada and Switzerland, the Obelis Group secures a prime position to support your compliance in those important markets.”
Buyer Snapshot
Best for
- Non-Swiss manufacturers seeking Swiss market access.
- Companies requiring a Swiss Authorised Representative (CH-REP).
- Medical device, cosmetic, and toy manufacturers.
How engagement typically works
- End-to-end regulatory support.
- Consultative approach to compliance challenges.
Typical deliverables
- Designation as Swiss Authorised Representative.
- Product registration with Swissmedic.
- Technical documentation review and preparation.
- Regulatory consulting and training.
Good to know
- Best when navigating Swiss regulatory requirements for medical devices, cosmetics, and other specified product categories.
HQ:
Brussels, BE
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Find 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, IVD
Vigilance Contact Support:
Yes
Labeling Support:
Yes
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Swiss Entity Canton Or Region:
Baar / ZG (Canton of Zug)
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
Non-EU manufacturers without an EAR must appoint a Swiss Authorized Representative immediately. Manufacturers need to register devices with Swissmedic.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Medical Devices (MD), In-vitro medical devices (IVD)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Baar / ZG
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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