Your Trusted Regulatory Partner for Success in Switzerland
Engaging with medDO and ivDO
Flexible regulatory terms, tailored regulatory intelligence, and local representation in Switzerland (CHREP) for seamless compliance and market access
OMC Medical – Your Trusted Swiss Authorized Representative (CH-REP)
At OMC Medical, we specialize in assisting medical device manufacturers in navigating Switzerland’s complex regulatory framework. With our expertise in Swiss regulatory requirements and Swiss Authorized Representative (CH-REP) services, we ensure a seamless approval process for your products. Whether you need support with device registration, technical documentation, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in Switzerland provides comprehensive regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the Swiss medical device market
OMC Benefits
- Regulatory Expertise – Extensive knowledge of Swiss medical device regulations and compliance requirements.
- Seamless Market Access – Ensuring smooth entry into the Swiss market while meeting Swissmedic’s regulatory standards.
- End-to-End Compliance Support – From device registration to post-market surveillance, we cover all regulatory aspects.
- Dedicated Local Representation – Acting as your official CH-REP for communication with Swiss medic and local authorities.
- Trusted by Global Manufacturers – Proven track record of assisting medical device companies worldwide.
Partner with OMC Medical and ensure hassle-free regulatory compliance for your medical devices in Switzerland
Discover tailored solutions across pharmaceuticals, medical devices and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
Navigating Switzerland’s regulatory landscape under MedDO (Medical Devices Ordinance) and IvDO (In Vitro Diagnostic Ordinance) requires a Swiss Authorized Representative (CH-REP) for non-Swiss manufacturers. At OMC Medical, we offer comprehensive CH-REP services, ensuring compliance with Swiss regulations, facilitating product registration, post-market surveillance, technical documentation review, and regulatory updates. Whether you’re launching medical devices or IVDs in Switzerland, our expertise guarantees a smooth, hassle-free market entry. Trust OMC Medical for regulatory excellence and seamless Swiss market access
Switzerland’s Ordinance on Foodstuffs and Utility Articles (OSAV) mandates that non-Swiss cosmetic manufacturers appoint a Swiss Authorized Representative (CH-REP) to ensure compliance before entering the market. At OMC Medical, we specialize in product notification, regulatory compliance, safety assessments, ingredient validation, labeling review, and post-market surveillance for cosmetic products. Our team ensures your products meet Swiss regulations seamlessly, allowing you to focus on growth while we handle compliance. Partner with OMC Medical for a smooth and compliant Swiss market entry
Switzerland’s Therapeutic Products Act (TPA) and Swissmedic regulations require non-Swiss pharmaceutical manufacturers to appoint a Swiss Authorized Representative (CH-REP) for market access. At OMC Medical, we provide expert support in product registration, regulatory compliance, dossier preparation, pharmacovigilance, labeling review, and post-market surveillance to ensure seamless compliance with Swiss regulatory requirements. With our in-depth knowledge of Swissmedic approvals and local market regulations, we help pharmaceutical companies achieve a hassle-free and compliant entry into the Swiss market. Partner with OMC Medical and ensure regulatory success in Switzerland
Switzerland requires non-Swiss manufacturers of medical devices, in vitro diagnostics (IVDs), cosmetics, and pharmaceuticals to appoint a Swiss Authorized Representative (CH-REP) to legally market their products. As your dedicated CH-REP, OMC Medical ensures full compliance with Swissmedic and MDR/IVDR requirements, handling product registration, technical documentation review, post-market surveillance, vigilance reporting, and regulatory representation. Our expertise helps you navigate Swiss regulatory pathways smoothly, ensuring your products meet all safety, quality, and compliance standards for market entry. Trust OMC Medical for reliable and expert regulatory support in Switzerland
Accurate translations are crucial for regulatory compliance in Switzerland, ensuring that medical devices, IVDs, cosmetics, and pharmaceuticals meet Swissmedic and CH-REP requirements. At OMC Medical, we provide precise, industry-specific translations of technical documentation, labeling, user manuals, safety data sheets, and regulatory submissions in German, French, and Italian—the official languages of Switzerland. Our expert team ensures that your documents are clear, compliant, and ready for market approval. Partner with us for seamless multilingual regulatory support and smooth market access in Switzerland
Expand Your Reach in Switzerland with a Trusted CHREP Partner
Navigating Swiss medical device regulations? We provide expert Swiss Authorized Representative (CH-REP) services to ensure swift compliance, hassle-free approvals, and smooth market access under Swissmedic regulations
About OMC
At OMC Medical, we specialize in providing Swiss Authorized Representative (CH-REP) services to help non-Swiss manufacturers comply with Switzerland’s medical device regulations.
With years of expertise in EU MDR, IVDR, and CE Marking, we ensure seamless market entry into Switzerland while meeting all regulatory requirements set by Swissmedic
What is a Swiss Authorized Representative (CH-REP)?
A Swiss Authorized Representative (CH-REP) is required for non-Swiss manufacturers to sell medical devices in Switzerland. They ensure regulatory compliance, device registration, communication with Swissmedic, and post-market surveillance. Appointing a CH-REP like OMC Medical streamlines market entry and ensures compliance
Looking for a Reliable CHREP Partner?
1: Regulatory Compliance
- Ensure the manufacturer meets Swiss medical device regulations (MedDO).
2: Device Registration
- Register the device with Swissmedic before market entry.
3: Technical Documentation
- Maintain access to the manufacturer’s technical files for audits
4: Communication with Authorities
- Act as the official liaison between Swissmedic and the manufacturer.
5: Post-Market Surveillance
- Monitor product performance and report adverse events
6: Labeling & Packaging Compliance
- Verify that product labeling meets Swiss regulatory requirements.
7: Declaration of Conformity
- Ensure the device meets conformity requirements before distribution
8: Legal Responsibility
- Represent the manufacturer in case of regulatory inquiries or compliance issues.
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
Key Responsibilities of a CH-REP
- Regulatory Compliance: Ensuring products meet Swissmedic requirements
- Device Registration: Submitting technical documentation and declarations
- Communication with Authorities: Acting as the official contact for Swissmedic
- Post-Market Surveillance: Monitoring safety and handling incident reporting
- Labeling & Documentation: Ensuring products have Swiss-compliant labeling
Why Do You Need a Swiss Authorized Representative (CH-REP)?
Under Swiss regulations (MedDO), non-Swiss medical device manufacturers must appoint a CH-REP to legally market their products in Switzerland. We help manufacturers meet compliance requirements while ensuring seamless regulatory support
- OMC Medical provides comprehensive CH-REP services across Switzerland, ensuring full compliance with Swiss medical device regulations (MedDO
- Nationwide Representation – Acting as your CH-REP across Switzerland.
- Regulatory Liaison – Managing all interactions with Swissmedic
- Full Compliance Support – Ensuring adherence to Swiss medical device regulations (MedDO)
- Want to Sell in Switzerland.? Let’s Make It Happen
Our CH-REP Services
- Device Registration & Documentation – Ensuring all regulatory documents are correctly submitted
- Labeling & UDI Compliance – Properly displaying CH-REP details on packaging
- Post-Market Surveillance (PMS) – Ongoing monitoring & incident reporting
- Swiss Responsible Person (SRP) Services – Acting as your legal representative in Switzerland
- Want a Smooth Market Entry?
Who Needs a Swiss Authorized Representative?
- You must appoint a Swiss Authorized Representative if you are:
- A non-Swiss manufacturer selling medical devices in Switzerland
- A distributor/importer working with non-Swiss manufacturers
- A company without a legal presence in Switzerland but wishing to enter the Swiss market
Why Choose Us as Your CH-REP?
- Regulatory Experts – Decades of experience in medical device compliance
- Fast & Reliable Support – Swift onboarding & documentation processing
- Transparent & Cost-Effective – No hidden fees, competitive pricing
- Dedicated Compliance Team – Ensuring continuous market access with regulatory updates
Ensure Compliance & Expand Your Reach
How Our CH-REP Process Works
- Step 1: Consultation & Compliance Review
- Step 2: Sign a CH-REP Agreement
- Step 3: Swissmedic Registration & Labeling Compliance
- Step 4: Continuous Monitoring & Post-Market Support
Looking for a hassle-free regulatory partner?
MedDO
Registration
Authorized Representative
EU/MDR
Virtual Importer
Technical
Document
Quality
Assurance
Why Work With Us?
- Trusted by medical device manufacturers worldwide
- Expert regulatory consultants with a proven track record
- Quick turnaround time for Swiss medical device regulations (MedDO).
- 100% compliance assurance with Swissmedic
Have a Business Query? Let us Talk
Frequently Asked Questions (FAQ)
A Swiss Authorized Representative (CH-REP) is required for non-Swiss medical device manufacturers to legally sell in Switzerland. Without one, your products cannot enter the market.
You must ensure compliance with Swissmedic regulations, including appointing a CH-REP, submitting documentation, and labeling your devices accordingly.
With our expert regulatory support, we can get your Swissmedic compliance process completed quickly and efficiently within the required timeframe.
Still Have Questions? Contact Us Now for a Free Consultation