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) for medical devices, IVDs, cosmetics, and pharmaceuticals.
* Facilitates product registration and market access in Switzerland.
* Provides support for ISO 13485 and Quality Management Systems (QMS).
* Offers services related to cosmetic product registration, notification, and claims.
* Assists with pharmaceutical product registration and market authorization.
* 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) for medical devices, IVDs, cosmetics, and pharmaceuticals.
* Facilitates product registration and market access in Switzerland.
* Provides support for ISO 13485 and Quality Management Systems (QMS).
* Offers services related to cosmetic product registration, notification, and claims.
* Assists with pharmaceutical product registration and market authorization.
* Provides translation, localization, and proofreading services.
**Reputation / proof points**
* Holds ISO 13485:2016 certification.
* Holds ISO 17100:2015 certification.
Additional information
OMC Medical (CHREP) specializes in navigating the complexities of Swiss regulations for a range of products, including medical devices, in vitro diagnostic devices, cosmetics, and pharmaceuticals. Their services extend to ensuring compliance with specific standards like ISO 13485 for medical devices and GMP regulations for cosmetics and pharmaceuticals. Buyers can expect support with product registration, acting as the appointed representative, and managing claims. The company also offers essential translation and localization services, crucial for meeting Swiss language requirements across different regions of the country. Engagement typically involves understanding the specific product category and the necessary steps for market entry and ongoing compliance within Switzerland.
Key Highlights
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Acts as a Swiss Authorized Representative (CH-REP) for medical devices, IVDs, cosmetics, and pharmaceuticals.
Source
“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.”
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Provides support for ISO 13485 and Quality Management Systems (QMS) for medical devices.
Source
“ISO 13485 및 QMS 지원”
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Offers services for cosmetic product registration, notification, claims, and GMP regulations.
Source
“화장품 제품 등록 및 신고 대리인 클레임 대행 GMP 규제”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking a Swiss Authorized Representative (CH-REP)
- Manufacturers of medical devices, IVDs, cosmetics, and pharmaceuticals
- Businesses needing assistance with product registration in Switzerland
How engagement typically works
- Retainer-based services for ongoing representation
- Project-based support for registration and compliance
- Consultative approach to regulatory challenges
Typical deliverables
- CH-REP designation on product labels and documentation
- Completed product registrations and notifications
- QMS documentation and audit support
- Regulatory compliance reports
- Localized product information
Good to know
- Best when the primary market focus is Switzerland.
- Requires clear product classification and documentation for accurate service provision.
HQ:
London, Switzerland
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best 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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