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