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 specialized services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Act as the Swiss Authorised Representative (CH-REP), a mandatory role for non-Swiss manufacturers since May 2022 due to the Mutual Recognition Agreement's update.
* Manage Swiss Product Registration with Swissmedic, as Switzerland does not have access to EUDAMED.
* Assist in preparing and maintaining Technical Documentation compliant with EU MDR requirements, including Post-market Surveillance (PMS) plans and reports.
* Provide Swiss consultancy, legal advice, and training to help manufacturers understand and comply with Swiss market requirements.
* Support manufacturers in appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law.
* Offer services for Medical Devices (MD), In-vitro Medical Devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
**Reputation / proof points**
* Established presence with offices in Switzerland, the EU (Brussels), and the UK.
* Over 32 years of regulatory expertise.
* Company Registration Number: CHE-407.391.181 (Switzerland).
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 specialized services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Act as the Swiss Authorised Representative (CH-REP), a mandatory role for non-Swiss manufacturers since May 2022 due to the Mutual Recognition Agreement's update.
* Manage Swiss Product Registration with Swissmedic, as Switzerland does not have access to EUDAMED.
* Assist in preparing and maintaining Technical Documentation compliant with EU MDR requirements, including Post-market Surveillance (PMS) plans and reports.
* Provide Swiss consultancy, legal advice, and training to help manufacturers understand and comply with Swiss market requirements.
* Support manufacturers in appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law.
* Offer services for Medical Devices (MD), In-vitro Medical Devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
**Reputation / proof points**
* Established presence with offices in Switzerland, the EU (Brussels), and the UK.
* Over 32 years of regulatory expertise.
* Company Registration Number: CHE-407.391.181 (Switzerland).
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 update to the Mutual Recognition Agreement. Obelis facilitates this by acting as the CH-REP, ensuring compliance with Swiss law, which mandates a professional agency for this function. They also handle product registration directly with Swissmedic, as Switzerland does not integrate with the EU's EUDAMED system. Their services extend to ensuring technical documentation meets EU MDR standards and is maintained for the required duration, typically 10 years (15 for implantable devices).
Key Highlights
-
Obelis specializes in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles.
Source
“specializing in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles”
-
Acts as the mandatory Swiss Authorised Representative (CH-REP) for non-Swiss manufacturers.
Source
“it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative.”
-
Manages Swiss Product Registration with Swissmedic, as Switzerland is not connected to EUDAMED.
Source
“Registration and notification obligations will be run via Swissmedic, as Switzerland does not have access to EUDAMED.”
-
Possesses over 32 years of regulatory expertise.
Source
“our 32 years of regulatory expertise”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Non-Swiss manufacturers of medical devices, IVDs, cosmetics, toys, food supplements, and motor vehicles needing market access in Switzerland.
- Companies requiring a dedicated Swiss Authorised Representative (CH-REP).
How engagement typically works
- Consultative approach to regulatory compliance.
- End-to-end service for market access.
Typical deliverables
- Designation as Swiss Authorised Representative (CH-REP).
- Swiss Product Registration filings.
- Technical Documentation review and maintenance.
- Regulatory consultancy and training.
Good to know
- Best when a deep understanding of Swiss medical device regulations (MedDO) and EU MDR is required for market entry.
HQ:
Brussels, BE
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, IVD
Vigilance Contact Support:
Yes
Labeling Support:
Yes
Swiss Local Contact:
Yes
Can Be Named On Label:
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
Manufacturers must appoint a Swiss Authorised Representative (CH-REP) immediately if they do not have an EAR. Obelis registers devices with SwissMedic. Technical documentation must be drawn up and kept for at least 10 years (15 for implantable devices).
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 (Canton of Zug)
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
