THE SMOOTH WAY TO GET ACCESS TO THE CH MARKET.
Anette Skowronsky CEO FG-Health Concepts GmbH
Welcome to fg-health.ch
Swissmedic compliance subscription by FG-Health Concepts GmbH
We can be your authorized CH representative according to the Swiss and guideline for medical devices regulation on a subscription basis
Our collaboration enables you.
- to sell your products in the Swiss market and
- to put our name and our address on your product labeling, packaging, and user manuals.
Services.
We take care of the following issues.
- We register your products with national competent authorities before they are marketed.
- We act as your primary contact for all national competent authorities.
- We keep a current copy of your technical documentation, which is available for inspection by the European competent authorities.
- We protect the confidentiality of your documentation. The authorized representative of the European Union (EC REP) can only show the technical documentation to the competent authorities on the legal basis.
- We represent you at the European Commission for advice on a recall of a medical device by one or more Member States.
- We maintain reports of the critical evaluation of all data collected during the clinical evaluations for review by the competent authorities.
- We will notify the Authorized Authorities of incidents or will be notified by them.
- We are responsible for incident reporting to the relevant authorities in collaboration with you and your distribution partners.
- We are always available to interact with you and the nationally competent authorities.
Some of our projects.
You manufacture medical devices (class I and class IIa) outside of the Switzerland (CH)?
You want to sell your medical devices in the CH market?
You need an authorized representative (AR) in the CH?