22.11.2022
Legal

Import medical devices

There is important information for every manufacturer or importer who wants to sell medical devices in Switzerland AG.

On May 19, 2021, the Swiss Federal Council adopted supplementary provisions to the implementation law in the area of medical devices. These entered into force simultaneously with the totally revised Medical Devices Ordinance (MepV) and a new Ordinance on Clinical Trials with Medical Devices (KlinV-Mep) on May 26, 2021.

Since December 31, 2021, medical devices from manufacturers not domiciled in Switzerland may only be brought into Switzerland if a person domiciled in Switzerland has been authorized by this manufacturer (Swiss authorized representative / Swiss representative = CH-REP). A written order is required. This is a new requirement according to the new Swiss MepV (studies, 4 years experience in quality management of medical devices, technical documentation of medical devices). The tasks of this authorized person (CH-REP) are the same as described in Article 11 MDR. In addition, this authorized person (CH-REP) must have the technical knowledge and the necessary experience. As an attachment we send a list of possible companies / representatives who could take over this task.

If our members purchase medical devices from a foreign distributor with a Swiss representative (CH-REP), they must be registered as an importer with Swiss Medic and create and maintain a manual including additional documents (registration approx. CHF 300.- + annual recurring costs of approx. CHF 2000.- to 3000.- for implementation and training of the manual to be maintained).

You can still obtain medical devices from a manufacturer or distributor based in Switzerland without any problems. The Swiss manufacturer or Swiss distributor is then obliged to comply with the points listed above.

Please inform yourself about the regulations directly at Swiss Medic (www.swissmedic.ch) or a possible Swiss representative (= CH-REP) on the list. We assume that Swiss Medic will closely monitor compliance with the new regulations in the future.

AXXOS GmbH
Mr. Wipf Markus |info@axxos.ch

Best Care Consulting GmbH
Mr. Birchler Beat |b.birchler@bestcareconsulting.com

confinis AG - regulatory compliance worldwide
Mr. Steffen Beat U. |info.ch@confinis.com

Decomplix
Mr. Hirt Beni | beni@decomplix.com

Effectum Medical AG
Ms. Neuberger Ulrike | ulrike.neuberger@effectummedical.com

Inspera GmbH
Mr. Hochuli Martin |martin.hochuli@inspera.ch

ISS AG, Integrated Scientific Services
Mr. Riedwyl Hansjörg | hansjoerg.riedwyl@iss-ag.ch

Medidee Services SA
Mr. Maier Michael | michael.maier@medidee.com

QS Engineering AG
Mr. Moor Eugen |e.moor@qs-engineering.ch

QUNIQUE GmbH
Ms. Hakim Angelina |angelina.hakim@qunique.ch

The Tao of Excellence
Ms. Roth Jasminka | meetus@taoexcellence.ch

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