SWISS AUTHORIZED REPRESENTATIVE
A Swiss Authorized Representative (CH-REP) is mandatory for foreign manufacturers and Swiss importers. The CH-REP is responsible for the proper communication between the manufacturer located in a foreign country and the Swiss Competent Authority to ensure that the requirements according to the Swiss regulation are fulfilled.
PMSystem as CH-REP will provide you a continuous support for regulatory and quality aspects and more by offering the following services:
- PMSystem as CH-REP for your Medical Devices.
- Person Responsible for Regulatory Compliance (PRRC) – Mandatory for CH-REP.
- Create or Update the Quality Management System (QMS) to include the additional requirements as per Swiss regulation (MedDO).
- Support for implementing the additional requirements (Labeling, Swissmedic Registration, UDI,…).