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 that have a CE Mark do not require additional registration, but Swissmedic must be notified before placing certain types of devices, including Class I and IVD devices, on the market.
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 EU registration 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 EU authorized representative 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.
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