OMC Medical (CHREP)
OMC Medical is your trusted Swiss Authorized Representative (CH-REP) partner, ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.
OMC Medical specializes in assisting medical device manufacturers in navigating Switzerland’s complex regulatory framework. As your dedicated Swiss Authorized Representative (CH-REP), they ensure seamless compliance and market access for your products, covering medical devices, in vitro diagnostics (IVDs), cosmetics, and pharmaceuticals. Their expertise spans product registration, technical documentation, local representation, quality assurance, clinical evaluation, and post-market surveillance, ensuring your products meet Swissmedic and MedDO/IvDO requirements. They act as the official liaison between Swissmedic and manufacturers, maintaining access to technical files for audits and monitoring product performance. OMC Medical offers tailored solutions to help you achieve compliance and successfully enter the Swiss medical device, IVD, cosmetic, and pharmaceutical markets, ensuring a smooth and hassle-free market entry. With a proven track record, OMC Medical is a trusted partner for global manufacturers seeking regulatory excellence and seamless market access in Switzerland. They provide end-to-end compliance support, from initial registration to ongoing vigilance reporting, ensuring your products meet all safety, quality, and compliance standards.
About
**Who they are**
OMC Medical (CHREP) is a dedicated Swiss Authorized Representative (CH-REP) partner focused on ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals within Switzerland.
**Expertise & scope**
* Acts as a Swiss Authorized Representative (CH-REP).
* Facilitates market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.
* Provides support for product registration and acts as an agent for cosmetics and pharmaceuticals.
* Offers ISO 13485 and Quality Management System (QMS) support for medical devices and IVDs.
* Assists with cosmetic product registration and notification, acting as an agent and handling claims.
* Supports pharmaceutical product registration and acts as a Market Authorisation Holder.
* Provides translation, localization, and proofreading services.
**Reputation / proof points**
* Holds ISO 13485:2016 certification.
* Holds ISO 17100:2015 certification.
OMC Medical (CHREP) is a dedicated Swiss Authorized Representative (CH-REP) partner focused on ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals within Switzerland.
**Expertise & scope**
* Acts as a Swiss Authorized Representative (CH-REP).
* Facilitates market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.
* Provides support for product registration and acts as an agent for cosmetics and pharmaceuticals.
* Offers ISO 13485 and Quality Management System (QMS) support for medical devices and IVDs.
* Assists with cosmetic product registration and notification, acting as an agent and handling claims.
* Supports pharmaceutical product registration and acts as a Market Authorisation Holder.
* Provides translation, localization, and proofreading services.
**Reputation / proof points**
* Holds ISO 13485:2016 certification.
* Holds ISO 17100:2015 certification.
Additional information
OMC Medical (CHREP) emphasizes its role in navigating the complexities of Swiss regulations for various product categories. For medical devices and IVDs, they offer services including product registration and acting as an authorized representative, alongside support for ISO 13485 and QMS. For cosmetics, their services extend to registration, notification, acting as an agent, claims management, and GMP regulatory compliance. Pharmaceutical clients benefit from product registration support, market authorization holder services, and GMP compliance assistance. The company also provides essential translation and localization services to ensure products meet local language requirements.
Key Highlights
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Acts as a trusted Swiss Authorized Representative (CH-REP) partner.
Source
“OMC Medical is your trusted Swiss Authorized Representative (CH-REP) partner”
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Ensures seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.
Source
“ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.”
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Provides ISO 13485 and QMS support for medical devices and IVDs.
Source
“ISO 13485 및 QMS 지원”
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Offers cosmetic product registration and notification services, acting as an agent.
Source
“화장품 제품 등록 및 신고 대리인”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking a Swiss Authorized Representative (CH-REP).
- Manufacturers of medical devices, IVDs, cosmetics, and pharmaceuticals entering the Swiss market.
How engagement typically works
- Regulatory compliance partnership.
- Market access facilitation.
Typical deliverables
- CH-REP designation.
- Product registration support.
- QMS documentation and support.
- Translation and localization services.
Good to know
- Best when requiring a local Swiss presence for regulatory compliance.
HQ:
London, Switzerland
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:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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:
IVD
Swiss Local Contact:
Yes
Labeling Support:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
CH
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
Intake → mandate agreement → labeling/documentation check → Swiss workflows live
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Swiss Entity Canton Or Region
CH
Labeling Support
Yes
Swiss Local Contact
Yes
Can Be Named On Label
Yes
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