CH-Importer: What is it and who needs it? A CH-Importer is a natural or legal entity based in Switzerland responsible for importing medical devices into the country. While the CH-REP holds regulatory responsibility, the CH-Importer ensures that imported products comply with Swiss regulations and are properly placed on the market. Why is a CH-Importer required?  Ensuring Compliance: The CH-Importer verifies that products meet the requirements of the Medical Devices Ordinance (MedDO).  Product Traceability: The CH-Importer documents imported medical devices and ensures they can be recalled in case of safety concerns.  Collaboration with CH-REP and Authorities: The CH-Importer works closely with the CH-REP and relevant authorities to comply with all regulatory requirements. Who needs a CH-Importer?  Non-Swiss Manufacturers: These require a CH-Importer if they do not have a direct presence in Switzerland.  Distributors and Retailers: If they import medical de...

  CH-REP: What Is It and Who Needs It? What Is a CH-REP? A CH-REP (Swiss Authorized Representative) is a natural or legal person based in Switzerland who acts as a representative for companies wishing to distribute medical devices on the Swiss market. The abbreviation "CH-REP" stands for "Swiss Responsible Person" and refers to a key role in ensuring compliance with regulatory requirements under the Swiss Medical Devices Ordinance (MedDO). Why Is a CH-REP Required? According to the Medical Devices Ordinance (MedDO, SR 812.213), manufacturers without a registered place of business in Switzerland must appoint a CH-REP. This representative assumes essential responsibilities to ensure the conformity of products with Swiss regulations: Legal Responsibility: The CH-REP serves as the official representative of the manufacturer and assumes regulatory responsibility towards Swiss authorities. Regulatory Compliance: Ensures that all requirements of the Medical Devices Act are...

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...