Why do you need a Swiss Authorized Representative (CH-REP)?

Author: Pragash Vijay, Regulatory Affairs Specialist

A Swiss Authorized Representative (CH-REP) is now mandatory after the abrogation of the Mutual Recognition Agreement (MRA) between Europe and Switzerland. 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 CH regulation are fulfilled.

Therefore, a CH-REP must be appointed by all Medical Devices (MD) manufacturers that are located in a foreign country and importing MD into Switzerland by:

  • 12.2021 for class III, IIb implants and active implants MD
  • 03.2022 for class IIb non-implantable and IIa MD
  • 07.2022 for class I MD.

Why do you need PMSystem as partner for CH-REP or for PRRC?

  • To be compliant with the Swiss legislation
  • To ensure cost effective solution
  • To guarantee all confidentiality aspects
  • To avoid any conflict of interest
  • To involve competent resources
  • To have permanently a Person Responsible for Regulatory Compliance (PRRC) available
  • To mitigate the impact of the staff turnover on the PRRC function.

Moreover, PMS is a consulting company specialized in the field of Regulatory Affairs, Quality Management Systems, ISO compliance aspects, CE marking for MD.

Using our know-how and expertise, PMSystem offers a complete package to support you in successfully dealing with these new regulatory requirements and challenges.  

Our strategy, based on risk approach, applies to all manufacturers based outside Switzerland and Swiss importer in order to ensure an efficient registration process according to CH legislation.

Services offered

  • 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).