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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Switzerland, to expedite the preparation of your medical device or IVD registration application.

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.

SPECIAL REQUIREMENTS:

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.

LOCAL FEES:

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.

Last updated on March 29, 2019.