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 specializing in regulatory services for medical devices and in vitro diagnostic devices (IVDs) within Switzerland. They ensure compliance with the latest Swiss regulations.
**Expertise & scope**
* Expert regulatory services for medical devices and IVDs.
* Act as a Swiss Authorized Representative (CH-REP).
* Function as a CH Importer.
* Focus on compliance with new Swiss regulations.
**Coverage / proof points**
* Coverage: Switzerland (CH)
TAS SAT AG is a Swiss Authorized Representative (CH-REP) and CH Importer specializing in regulatory services for medical devices and in vitro diagnostic devices (IVDs) within Switzerland. They ensure compliance with the latest Swiss regulations.
**Expertise & scope**
* Expert regulatory services for medical devices and IVDs.
* Act as a Swiss Authorized Representative (CH-REP).
* Function as a CH Importer.
* Focus on compliance with new Swiss regulations.
**Coverage / proof points**
* Coverage: Switzerland (CH)
Additional information
TAS SAT AG provides essential services for manufacturers seeking to place medical devices and IVDs on the Swiss market. As a designated CH-REP and CH Importer, they navigate the complexities of Swiss regulatory requirements, ensuring that products meet all necessary compliance standards. Their expertise is particularly valuable given the evolving regulatory landscape in Switzerland, which has specific requirements distinct from EU regulations. Engaging TAS SAT AG allows manufacturers to establish a compliant market presence without needing a direct physical establishment in Switzerland.
Key Highlights
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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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Acts as both a Swiss Authorized Representative (CH-REP) and CH Importer.
Source
“They act as a CH-REP (Authorised Representative) and CH Importer, ensuring compliance with new Swiss regulations.”
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Ensures compliance with new Swiss regulations.
Source
“ensuring compliance with new Swiss regulations.”
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
- Medical device and IVD manufacturers targeting the Swiss market.
- Companies needing a Swiss Authorized Representative (CH-REP) or CH Importer.
How engagement typically works
- Regulatory compliance support.
- Acting as a local representative.
Typical deliverables
- CH-REP services.
- CH Importer services.
- Regulatory compliance assurance for the Swiss market.
Good to know
- Best when a local Swiss presence is required for market access.
HQ:
Zurich, 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, CH Importer services (optional)
Device Classes Supported:
IVD
Swiss Local Contact:
Yes
Labeling Support:
No
Can Be Named On Label:
No
Vigilance Contact Support:
Yes
Additional ch_rep Details
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
