Switzerland Medical Device Registration is governed by the Swiss Federal Act on Medicinal Products and Medical Devices (TPA) and the Medical Devices Ordinance (MedDO), overseen by the national authority Swissmedic. Since the European Union’s Medical Device Regulation (EU MDR) came into effect in May 2021, Switzerland is treated as a third country by the EU, and as a result, manufacturers from the EU and other countries must now meet Swiss-specific requirements to market medical devices in Switzerland. One of the key requirements is the appointment of a Swiss Authorized Representative (CH-REP) for all foreign manufacturers. Additionally, certain devices and economic operators must register with Swissmedic depending on their classification. While CE-marked medical devices are still accepted, they must comply with additional Swiss regulatory obligations, such as local labeling, vigilance reporting, and post-market surveillance specific to Swiss law.The Switzerland Medical Device Registration process ensures that only safe, effective, and compliant devices enter the market. Manufacturers seeking access to the Swiss market must stay updated on regulatory changes and ensure full compliance with MedDO to avoid delays or penalties.
