TAS SAT AG
TAS SAT AG offers expert regulatory services for medical devices and IVDs in Switzerland. They act as a CH-REP (Authorised Representative) and CH Importer, ensuring compliance with new Swiss regulations.
TAS SAT AG provides specialized regulatory services for medical devices and in vitro diagnostics (IVDs) within Switzerland. Following the termination of the Mutual Recognition Agreement with the EU, Switzerland now operates under its own Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO), making it a "third country" for foreign manufacturers and distributors. As a Swiss-domiciled CH-REP (Authorised Representative), TAS SAT AG serves as a crucial liaison between non-Swiss manufacturers and Swiss authorities. They ensure compliance with Swiss laws, which is mandatory for selling medical devices and IVDs in the Swiss market. Their responsibilities include checking declarations of conformity, technical documentation, and manufacturer registration obligations, as well as reporting serious incidents and forwarding complaints. Additionally, TAS SAT AG can function as a CH Importer, acting as the point of contact for non-Swiss distributors to ensure compliance with Swiss import regulations for medical devices and IVDs. By leveraging their expertise, TAS SAT AG helps reduce the regulatory burden and associated financial costs for businesses entering the Swiss market.
About
**Who they are**
TAS SAT AG is a Swiss Authorized Representative (CH-REP) and CH Importer provider, specializing in regulatory services for medical devices and in vitro diagnostic devices within Switzerland. They focus on ensuring compliance with the latest Swiss regulations.
**Expertise & scope**
* Act as a Swiss Authorized Representative (CH-REP).
* Function as a Swiss Importer (CH Importer).
* Provide regulatory services specifically for medical devices and IVDs.
* Ensure adherence to new Swiss regulatory requirements.
**Reputation / proof points**
* Coverage: Switzerland (CH)
* Languages: English, German, French
TAS SAT AG is a Swiss Authorized Representative (CH-REP) and CH Importer provider, specializing in regulatory services for medical devices and in vitro diagnostic devices within Switzerland. They focus on ensuring compliance with the latest Swiss regulations.
**Expertise & scope**
* Act as a Swiss Authorized Representative (CH-REP).
* Function as a Swiss Importer (CH Importer).
* Provide regulatory services specifically for medical devices and IVDs.
* Ensure adherence to new Swiss regulatory requirements.
**Reputation / proof points**
* Coverage: Switzerland (CH)
* Languages: English, German, French
Additional information
For medical device and IVD manufacturers seeking to place their products on the Swiss market, TAS SAT AG offers dedicated services as a Swiss Authorized Representative and Importer. Their expertise is tailored to navigate the specific regulatory landscape of Switzerland, ensuring that products meet the requirements of the new Swiss regulations. Engaging with TAS SAT AG facilitates market access by providing a local presence and ensuring all necessary compliance obligations are met. Buyers should consider the specific device classification and intended market within Switzerland when engaging their services.
Key Highlights
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Acts as a Swiss Authorized Representative (CH-REP) and CH Importer.
Source
“They act as a CH-REP (Authorised Representative) and CH Importer”
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Specializes in regulatory services for medical devices and IVDs in Switzerland.
Source
“TAS SAT AG offers expert regulatory services for medical devices and IVDs in Switzerland.”
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Ensures compliance with new Swiss regulations.
Source
“ensuring compliance with new Swiss regulations.”
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Supports communication in English, German, and French.
Source
“Languages: English, German, French”
Certifications & Trust Signals
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Established presence as a Swiss Authorized Representative.
Source
“TAS SAT AG offers expert regulatory services for medical devices and IVDs in Switzerland.”
Buyer Snapshot
Best for
- Manufacturers of medical devices and IVDs
- Companies needing a Swiss Authorized Representative (CH-REP)
- Businesses requiring a Swiss Importer
How engagement typically works
- Regulatory representation
- Compliance assurance
Typical deliverables
- CH-REP services
- CH Importer services
- Regulatory compliance support for the Swiss market
Good to know
- Best when targeting the Swiss market for medical devices and IVDs.
HQ:
Zurich, 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, CH Importer services (optional)
Device Classes Supported:
IVD
Swiss Local Contact:
Yes
Labeling Support:
No
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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