Welcome to FG-HEALTH Concepts GmbH Switzerland
Swiss representative (CH-REP) for medical devices
- Assumption of the CH-REP mandate in accordance with Art. 51 MepV
- Review of technical documentation and declaration of conformity
- Ensuring registration with Swissmedic
- Support with vigilance and reporting obligations
- Communication with authorities and market surveillance
- Advice on labeling and UDI requirements
- Support with regulatory issues relating to the Swiss market
Regulatory excellence for foreign manufacturers
For your market access in Switzerland.
With the entry into force of the revised Swiss Medical Devices Ordinance (MepV), EU manufacturers without a Swiss branch and international companies wishing to supply the Swiss market are required to appoint a Swiss authorized representative (CH-REP) in order to place medical devices on the Swiss market.
As your officially mandated CH-REP, we perform the necessary regulatory functions with the utmost professionalism, integrity, and commitment.
Our services as CH-REP
As your official Swiss representative, we represent your company in dealings with:
- Swissmedic
- Swiss economic operators
- Healthcare institutions
- Authorities and market surveillance bodies
We ensure that your products meet all regulatory requirements in Switzerland and can be placed on the market in a legally compliant manner.
Our responsibility and quality standards as CH-REP
Within the scope of our mandate, we perform all tasks defined by law in accordance with Art. 51 ff. MepV. These include in particular:
Regulatory expertise
Our experts have in-depth knowledge of the Swiss MepV as well as the European MDR and IVDR. We operate on the basis of current regulatory developments and official practice.
Structured governance
Clear responsibilities, defined escalation processes, and documented procedures ensure transparency and legal certainty.
Discretion and integrity
We treat all information as strictly confidential and meet the highest standards of data protection and compliance.
Long-term partnership
We see our role not only as legal representation, but also as a strategic partner for a sustainable market presence in Switzerland.
Our target groups
Our services are aimed at:
- International manufacturers of medical devices
- EU-based companies without their own branch in Switzerland
- Globally active corporations with complex product portfolios
- Organizations with high requirements for compliance, governance, and documentation standards
We have experience in dealing with extensive technical documentation, international quality management systems, and group-wide compliance structures.
Your entry into the Swiss market starts here!
Would you like to distribute your medical devices in Switzerland? We will guide you safely through all regulatory requirements.
Contact us for a no-obligation consultation. We look forward to hearing from you.
Contact
c/o cka consult ag
Baarerstrasse 95
6300 Zug
Schweiz
UID: CHE-342.943.050
Managing Director:
Anette Skowronsky
info@fg-health.ch
