Effectum CH-REP
Effectum CH-REP AG
Effectum CH-REP AG is your dedicated Swiss Authorized Representative, ensuring seamless market access for medical devices in Switzerland. We provide expert regulatory compliance and support.
Effectum CH-REP AG serves as your essential Swiss Authorized Representative, crucial for manufacturers outside Switzerland seeking to access the Swiss market. With the Medical Device Ordinance (MedDO) and In-Vitro Diagnostic Regulation (IvDV) fully in effect, appointing a Swiss Representative is mandatory. Our team comprises senior experts with extensive MedTech knowledge, offering specialized services including product registration, compliance with Swiss registration requirements, and collaboration with Swissmedic for audits and product sample requests. We also provide a designated Person Responsible for Regulatory Compliance (PRRC) and guarantee access to technical documentation. We streamline the process of becoming compliant, ensuring your products meet all necessary Swiss regulatory standards. Our goal is to facilitate your market entry and ongoing compliance with efficiency and expertise.
About
**Who they are**
Effectum CH-REP AG is a dedicated Swiss Authorized Representative focused on facilitating seamless market access for medical devices within Switzerland.
**Expertise & scope**
* Expert regulatory compliance and support for medical devices in the Swiss market.
* Ensures adherence to Swiss regulatory requirements for market entry.
**Reputation / proof points**
* Specializes in Swiss representation (CH coverage).
Effectum CH-REP AG is a dedicated Swiss Authorized Representative focused on facilitating seamless market access for medical devices within Switzerland.
**Expertise & scope**
* Expert regulatory compliance and support for medical devices in the Swiss market.
* Ensures adherence to Swiss regulatory requirements for market entry.
**Reputation / proof points**
* Specializes in Swiss representation (CH coverage).
Additional information
Effectum CH-REP AG serves as the official Swiss Authorized Representative, a crucial role for medical device manufacturers seeking to place their products on the Swiss market. This designation ensures that a local entity is responsible for regulatory compliance and communication with Swiss authorities. Their services are designed to streamline the process of market access, providing expert guidance on navigating the specific regulatory landscape of Switzerland. Buyers should consider the scope of representation needed and how Effectum CH-REP's expertise aligns with their device classification and intended market strategy within Switzerland.
Key Highlights
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Dedicated Swiss Authorized Representative (CH coverage)
Source
“Effectum CH-REP AG is your dedicated Swiss Authorized Representative, ensuring seamless market access for medical devices in Switzerland.”
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Expert regulatory compliance and support for medical devices
Source
“We provide expert regulatory compliance and support.”
Certifications & Trust Signals
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Established entity for Swiss market access
Source
“Effectum CH-REP AG is your dedicated Swiss Authorized Representative, ensuring seamless market access for medical devices in Switzerland.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing a dedicated Swiss Authorized Representative
How engagement typically works
- Regulatory compliance support
- Market access facilitation
Typical deliverables
- Swiss Authorized Representative services
- Regulatory compliance guidance
Good to know
- Best when focusing on the Swiss market
HQ:
Olten, CH
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:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
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:
Class I, Class IIa, Class IIb, Class III
Swiss Local Contact:
Yes
Vigilance Contact Support:
Yes
Labeling 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).
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
true
Supports MDR
false
Supports IVDR
false
