CH-REP.com bietet massgeschneiderte, produktspezifische Dienstleistungen für aus
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 bietet massgeschneiderte, produktspezifische Dienstleistungen für aus acts as an Authorised Representative in Switzerland for foreign medical device manufacturers and Swiss importers/distributors.
**Expertise & scope**
* Specialized services for foreign medical device manufacturers.
* Services for Swiss importers and distributors.
* Acts as the Authorised Representative within Switzerland.
* Focus on product-specific services.
**Reputation / proof points**
* Coverage: Switzerland (CH)
CH-REP.com bietet massgeschneiderte, produktspezifische Dienstleistungen für aus acts as an Authorised Representative in Switzerland for foreign medical device manufacturers and Swiss importers/distributors.
**Expertise & scope**
* Specialized services for foreign medical device manufacturers.
* Services for Swiss importers and distributors.
* Acts as the Authorised Representative within Switzerland.
* Focus on product-specific services.
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
CH-REP.com focuses on providing specialized, product-specific services tailored to the needs of foreign medical device manufacturers seeking representation in Switzerland. They also support Swiss importers and distributors. Their role as an Authorised Representative ensures that foreign manufacturers can effectively place their medical devices on the Swiss market while complying with local regulatory requirements. The company operates with a clear focus on the Swiss market, offering services in English, German, and French to facilitate communication and compliance.
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 Swiss representation
- Swiss importers and distributors requiring an Authorised Representative
How engagement typically works
- Product-specific service engagement
- Regulatory representation
Typical deliverables
- Authorised Representative services for Switzerland
- Product-specific compliance support
Good to know
- Best when requiring a dedicated Swiss Authorised Representative for medical devices.
HQ:
Münsingen, CH
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:
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
Swiss Entity Canton Or Region:
CH
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.
⚡ Instant booking available
Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices
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