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...