CH-REP.com
CH-REP.com provides specialized services for foreign medical device manufacturers and Swiss importers/distributors, acting as an Authorised Representative in Switzerland.
CH-REP.com offers tailored, product-specific services for foreign manufacturers and for importers and distributors in Switzerland. Since May 26, 2021, Switzerland is considered a third country to the EU, meaning mutual recognition of conformity assessment procedures no longer applies. Consequently, foreign manufacturers of medical devices must appoint a 'Swiss Authorised Representative'. CH-REP.com is available to serve as this representative for manufacturers outside of Switzerland. For Swiss importers and distributors of medical devices and in-vitro diagnostic devices, CH-REP.com provides competent and uncomplicated support to help them fulfill their obligations according to (EU) 2017/745 (Medical Device Regulation) and (EU) 2017/746 (IVDR).
About
**Who they are**
CH-REP.com acts as a specialized Authorized Representative in Switzerland for foreign medical device manufacturers and Swiss importers/distributors.
**Expertise & scope**
* Provides Authorised Representative services specifically for the Swiss market.
* Focuses on supporting foreign medical device manufacturers.
* Assists Swiss importers and distributors with regulatory representation.
* Services are available in English, German, and French.
**Reputation / proof points**
* Coverage: Switzerland (CH)
CH-REP.com acts as a specialized Authorized Representative in Switzerland for foreign medical device manufacturers and Swiss importers/distributors.
**Expertise & scope**
* Provides Authorised Representative services specifically for the Swiss market.
* Focuses on supporting foreign medical device manufacturers.
* Assists Swiss importers and distributors with regulatory representation.
* Services are available in English, German, and French.
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
For foreign medical device manufacturers seeking to place products on the Swiss market, CH-REP.com offers dedicated Authorised Representative services. They facilitate market access by acting as the local legal entity required by Swiss regulations. This ensures compliance for manufacturers who do not have an establishment within Switzerland. Their expertise covers the specific requirements for medical devices within the Swiss regulatory framework, providing a crucial link between manufacturers and Swiss authorities or market surveillance bodies.
Key Highlights
Certifications & Trust Signals
-
Established entity for Swiss regulatory representation.
Source
“Swiss Authorized Representative (CH-REP) services”
Buyer Snapshot
Best for
- Foreign medical device manufacturers needing a Swiss Authorized Representative
- Swiss importers/distributors requiring local regulatory representation
How engagement typically works
- Local representation for market access
- Compliance support for Swiss regulations
Typical deliverables
- Designated Swiss Authorized Representative
- Local point of contact for regulatory matters
Good to know
- Best when the manufacturer or importer requires a formal Swiss legal entity for regulatory compliance.
HQ:
Münsingen, 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, 26-100
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,000
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, IVD
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Supports MDR
true
Supports IVDR
true
Swiss Entity Canton Or Region
CH
Labeling Support
Yes
Swiss Local Contact
true
Vigilance Contact Support
Yes
Can Be Named On Label
true
Onboarding Steps
Requires detailed documentation regarding the device's technical file and quality management system.
