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 specialized provider of In-Country Representation and Regulatory Importer services for medical devices, IVDs, and cosmetics. They focus on empowering small and medium-sized companies in the health care and life sciences sectors to meet local regulatory requirements in key international markets.
- **Who they are**
MedEnvoy is a leader in medical device and IVD In-Country Representation and Regulatory Importer services, committed to helping clients navigate complex global regulations.
- **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.
- Services extend to other markets including EU Authorized Representative, UK Responsible Person, US FDA Agent, and more.
- **Reputation / proof points**
- Established in the Netherlands by experienced regulatory affairs executives.
- Offices in Switzerland, the US, and the EU.
- **Who they are**
MedEnvoy is a leader in medical device and IVD In-Country Representation and Regulatory Importer services, committed to helping clients navigate complex global regulations.
- **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.
- Services extend to other markets including EU Authorized Representative, UK Responsible Person, US FDA Agent, and more.
- **Reputation / proof points**
- Established in the Netherlands by experienced regulatory affairs executives.
- Offices in Switzerland, the US, and the EU.
Additional information
MedEnvoy emphasizes building strong customer relationships and leverages digital and AI technologies to deliver efficient, high-quality solutions. Their mission is to be a trusted partner in bringing health solutions to markets worldwide with speed and quality, ensuring patients globally can access safe and innovative healthcare products that meet local regulatory standards. They are committed to enabling clients to focus on innovation and growth by managing regulatory compliance.
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 registered office in Switzerland to place medical devices on the market.
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 needing Swiss representation.
- Small to medium-sized companies in health care and life sciences.
How engagement typically works
- Relationship-focused.
- Leveraging digital and AI technologies for efficiency.
Typical deliverables
- Swiss Authorized Representative (CH-REP) services.
- Regulatory Importer services.
- In-Country Representation.
Good to know
- Best when clients require support for medical devices, IVDs, or cosmetics in European markets.
HQ:
Basel, 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
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 CH-REP for manufacturers without a place of business in Switzerland to place medical devices on the market.
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 by MDR/IVDR support)
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
true
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