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. They specialize in navigating the regulatory landscape for medical devices and IVDs in Switzerland.
**Expertise & scope**
* Expert regulatory services for medical devices and IVDs.
* Act as a CH-REP (Authorised Representative).
* Act as a CH Importer.
* Ensure compliance with new Swiss regulations.
**Reputation / proof points**
* Coverage: Switzerland (CH)
TAS SAT AG is a Swiss Authorized Representative (CH-REP) and CH Importer provider. They specialize in navigating the regulatory landscape for medical devices and IVDs in Switzerland.
**Expertise & scope**
* Expert regulatory services for medical devices and IVDs.
* Act as a CH-REP (Authorised Representative).
* Act as a CH Importer.
* Ensure compliance with new Swiss regulations.
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
TAS SAT AG focuses on ensuring medical devices and IVDs meet Switzerland's specific regulatory requirements. As an Authorised Representative and Importer, they facilitate market access by managing compliance obligations. Buyers should consider the specific documentation and timelines required for CH-REP and CH Importer appointments to ensure a smooth onboarding process.
Key Highlights
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Offers services as a Swiss Authorized Representative (CH-REP).
Source
“They act as a CH-REP (Authorised Representative) and CH Importer”
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Provides CH Importer services for medical devices and IVDs.
Source
“They act as a CH-REP (Authorised Representative) and CH Importer”
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Ensures compliance with new Swiss regulations for medical devices and IVDs.
Source
“ensuring compliance with new Swiss regulations.”
Certifications & Trust Signals
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Specializes in Swiss regulatory representation.
Source
“TAS SAT AG offers expert regulatory services for medical devices and IVDs in Switzerland.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- IVD manufacturers needing regulatory representation in Switzerland
How engagement typically works
- Acting as appointed CH-REP
- Acting as appointed CH Importer
Typical deliverables
- Regulatory compliance for Swiss market entry
- Representation as an Authorised Representative
- Representation as an Importer
Good to know
- Best when engaging for Swiss regulatory compliance specific to 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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