Medical Device Registration and Approval in Switzerland
General country-specific regulatory information is provided on this page for medical device registration and approval in Switzerland.
Last updated on November 24th, 2021.
Medical Device Regulations and Classification in Switzerland
REGULATORY AUTHORITY:Medical device licensing in Switzerland is governed by Swissmedic, the Swiss agency for Therapeutic Devices. Devices are regulated by the EU list of Competent Authorities.
CLASSIFICATION SYSTEM: Medical devices are classified along the EU model, using risk-based rules.
Medical Devices: Classes I, IIa, IIb and III.
IVD Devices: Same as the EU – List A & B, Self testing, all others
TIMEFRAME: The CE registration process with the relevant competent authority (self-declaration process) takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
Class I: The registration process takes approximately the same time as in the EU.
Class II: The registration process takes approximately the same time as in the EU.
Class III: The registration process takes approximately the same time as in the EU.
IVD Devices: The registration process takes approximately the same time as in the EU.
Audits: An ISO 13485 audit, based on the CE requirements, is needed.
Technical Local Tests: There are no local testing requirements in Switzerland.
Clinical Evaluation/studies: There are no clinical evaluation studies required in Switzerland.
Application review fees: Not applicable
Manufacturer registration: Not applicable
LICENSE VALIDITY: Medical devices can remain on the Swiss market for as long as their CE Mark is valid, usually 5 years.
LICENSE TRANSFER: Similar to the EU, this process is not applicable.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative anywhere in the European Union is required.
ADDITIONAL INFORMATION: Swiss manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before they are placed on the market.
Mandatory notification for devitalised human tissue: Anyone wishing to import classical and active implantable medical devices with components from devitalised human tissue into Switzerland must notify Swissmedic.
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