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 Swiss Authorized Representative (CH-REP) partner dedicated to ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.

**Expertise & scope**
* Swiss Authorized Representative (CH-REP) services
* Product registration and notification for medical devices, IVDs, cosmetics, and pharmaceuticals
* Support for ISO 13485 and Quality Management Systems (QMS)
* GMP compliance support for pharmaceuticals
* Claim agency for cosmetics
* Localization, translation, and proofreading services

**Reputation / proof points**
* ISO 13485:2016 certified
* ISO 17100:2015 certified

Additional information

OMC Medical (CHREP) provides comprehensive support for market access in Switzerland across several regulated product categories. For medical devices and IVDs, they offer product registration and act as the authorized representative, with specific support for ISO 13485 and QMS. For cosmetics, their services include product registration and notification, acting as the representative, claim agency, and GMP regulatory support. Pharmaceutical clients benefit from product registration, market authorization holder services, and GMP compliance assistance. Additionally, they offer translation and localization services to meet language requirements.

Key Highlights

  • 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.”
  • Provides product registration and notification services for various regulated product categories. Source
    “의료 기기 및 IVD 제품 등록 공인 대리인 ISO 13485 및 QMS 지원”
  • Offers ISO 13485 and QMS support for medical devices and IVDs. Source
    “ISO 13485 및 QMS 지원”
  • Provides claim agency and GMP regulatory support for cosmetics. Source
    “화장품 제품 등록 및 신고 대리인 클레임 대행 GMP 규제”
  • Offers translation, localization, and proofreading services. Source
    “번역 로컬라이제이션 번역 언어 교정”

Certifications & Trust Signals

  • ISO 13485:2016 certified. Source
    “ISO 13485:2016 인증”
  • ISO 17100:2015 certified. Source
    “ISO 17100:2015 인증”

Buyer Snapshot

Best for
  • Companies seeking Swiss Authorized Representation (CH-REP)
  • Manufacturers of medical devices, IVDs, cosmetics, and pharmaceuticals
  • Businesses needing regulatory compliance and market access in Switzerland
How engagement typically works
  • Partnership for regulatory compliance
  • End-to-end service for product registration
  • Support for quality management systems
Typical deliverables
  • CH-REP designation
  • Product registration documentation
  • QMS implementation support
  • GMP compliance reports
  • Translated and localized product information
Good to know
  • Best when requiring a local Swiss entity for regulatory purposes.
HQ: London, Switzerland
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: 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

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
Request quotes
Cruxi - Regulatory Compliance Services