Swiss Authorized Representative for Medical Devices (CH-REP) The Swiss Authorized Representative (CH-REP) is a legally required entity for manufacturers outside Switzerland who wish to market their medical devices in the Swiss market. The CH-REP role was established with the introduction of the revised Medical Devices Act (MPG) and the Medical Devices Ordinance (MedDO) to align Swiss legislation with the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). Timeline of CH-REP and CH-Importer Introduction May 26, 2021: The revised Medical Devices Act (MPG) and MedDO come into force. December 31, 2021: The Mutual Recognition Agreement (MRA) between Switzerland and the EU for medical devices expires. Why is a CH-REP Necessary? With the expiration of the MRA, the previous simplifications for the import and distribution of medical devices from the EU to Switzerland ceased. Manufacturers outside Switzerland who wish to continue offering their products in the Swiss market are now required to...

Swissmedic: The Swiss Agency  for Therapeutic Products Swissmedic is the Swiss regulatory and supervisory authority for therapeutic products, including medical devices and pharmaceuticals. It is an independent public institution under federal law and operates under the Federal Department of Home Affairs (EDI). Swissmedic plays a key role in the regulation, approval, market surveillance, and safety of therapeutic products in Switzerland. Tasks and Responsibilities of Swissmedic Approval and Registration: Swissmedic is responsible for approving pharmaceuticals and medical devices. It evaluates the safety, efficacy, and quality of products before they can be marketed in Switzerland. Market Surveillance: The agency continuously monitors the safety and quality of products through inspections and vigilance reports to identify potential risks at an early stage. Safety Management: Swissmedic assesses safety risks and implements necessary measures, including recalls or safety warni...