Authorized Representative service for non-Swiss medical device manufacturers placing devices on the Swiss market.
Manufacturers based outside Switzerland must appoint a Swiss Authorized Representative (CH-REP) to place medical devices on the Swiss market, following Switzerland's regulatory framework post-MRA.
We act as your registered CH-REP contact, handling the regulatory liaison this role requires.
Non-Swiss medical device manufacturers placing devices on the Swiss market.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.