MedEnvoy
MedEnvoy provides expert In-Country Representation and Regulatory Importer services for medical devices, IVDs, and cosmetics in European markets
MedEnvoy simplifies bringing medical devices, IVDs, and cosmetics to market by overcoming complex regulations. They serve as a leading In-Country Representative and Regulatory Importer for European markets, including Switzerland, the EU, and the UK
About
MedEnvoy is a provider of In-Country Representation and Regulatory Importer services for medical devices, IVDs, and cosmetics, with a specific focus on European markets. They aim to empower small and medium-sized companies in the health care and life sciences industries by offering consolidated services to meet local regulatory requirements in key international markets.
**Who they are**
MedEnvoy is a specialized service provider focused on navigating complex regulatory landscapes for healthcare and life sciences products. They are committed to building strong customer relationships and leveraging technology to deliver efficient, high-quality solutions.
**Expertise & scope**
- Swiss Authorized Representative (CH-REP) services for medical devices and IVDs.
- Assistance with meeting Swiss regulatory requirements, including the Medical Device Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO).
- Support for manufacturers without a registered office in Switzerland.
- EU Authorized Representative services.
- UK Responsible Person services.
- US FDA Agent services.
- Services for Mexico, Egypt, Saudi Arabia, Israel, India, and Australia.
**Reputation / proof points**
- Established in the Netherlands by experienced regulatory affairs executives.
- Offices in Switzerland.
**Who they are**
MedEnvoy is a specialized service provider focused on navigating complex regulatory landscapes for healthcare and life sciences products. They are committed to building strong customer relationships and leveraging technology to deliver efficient, high-quality solutions.
**Expertise & scope**
- Swiss Authorized Representative (CH-REP) services for medical devices and IVDs.
- Assistance with meeting Swiss regulatory requirements, including the Medical Device Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO).
- Support for manufacturers without a registered office in Switzerland.
- EU Authorized Representative services.
- UK Responsible Person services.
- US FDA Agent services.
- Services for Mexico, Egypt, Saudi Arabia, Israel, India, and Australia.
**Reputation / proof points**
- Established in the Netherlands by experienced regulatory affairs executives.
- Offices in Switzerland.
Additional information
For medical device and IVD manufacturers without a place of business in Switzerland, appointing a Swiss Authorized Representative (CH-REP) is a regulatory requirement to place products on the market. MedEnvoy's services are designed to ensure compliance with Swiss regulations, which have been updated to align with EU standards like the MDR/IVDR. They emphasize their team's expertise in navigating these requirements, particularly following the non-renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, which has led Switzerland to be treated as a 'third country' in some regulatory aspects. MedEnvoy focuses on providing efficient and high-quality solutions to facilitate market access.
Key Highlights
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Provides Swiss Authorized Representative (CH-REP) services for medical devices and IVDs.
Source
“Optimize your operation with MedEnvoy as your Swiss Authorized Representative for medical device and IVD companies.”
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Assists manufacturers without a Swiss place of business in meeting regulatory requirements for market access.
Source
“If you do not have a place of business in Switzerland, you must appoint a CH-REP to place medical devices onto the market as it is required by Swiss regulations.”
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Offers a range of In-Country Representation services across multiple international markets.
Source
“EU Authorized Representative UK Responsible Person Swiss Authorized Representative US FDA Agent Mexico Registration Holder Egypt Registration Holder Saudi Arabia Authorized Representative Israel Registration Holder India Agent Australian TGA Sponsor”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking Swiss Authorized Representation.
- Companies without a registered office in Switzerland.
- Small and medium-sized businesses in healthcare and life sciences.
How engagement typically works
- Focus on building customer relationships.
- Leveraging digital and AI technologies for efficient solutions.
Typical deliverables
- Swiss Authorized Representative (CH-REP) designation.
- Regulatory compliance support for the Swiss market.
- In-Country Representation services.
Good to know
- Best when requiring representation for medical devices, IVDs, and cosmetics in European markets.
HQ:
Basel, 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
Can Be Named On Label:
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
Requires appointment of a local Swiss Authorized Representative if no place of business exists in Switzerland.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (implied for MDR/IVDR alignment)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Local Contact
Yes
Labeling Support
Implied by Swiss Authorized Representative role
Vigilance Contact Support
Implied by Swiss Authorized Representative role
Can Be Named On Label
Yes
