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General

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Your company is subject to the obligations of both the CH-REP and importer. The company must register (or appoint the representative such as TAS SAT AG) both as an importer and CH-REP and receive two CHRN.

The direct registration with Swissmedic is only possible if your company is Swiss-domiciled.

As a private person you are subject to the same obligations as any other authorised representative, importer or distributor.

No, you need only register once. You can inform Swissmedic of any changes (e.g. in your address) by means of a change notification.

MedDO – Medical Devices Ordinance of 1 July 2020; SR 812.213
IvDO – Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices; SR 812.219
MDR – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
IVDR – Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

CH-REP (Authorised Representative) Service

Art. 51 and 52 MedDO, Art. 44 and 45 IvDO
Art. 11 MDR, Art. 11 IVDR

To avoid unauthorized use of our CHRN, we’ll provide it only upon establishing our cooperation with you.

CH Importer Service

Art. 53 MedDO, Art. 46 IvDO
Art. 13 MDR, Art. 13 IVDR
Art. 55 para. 3 MedDO / Art. 30 para. 3 MDR or Art. 46 para. 3 IvDO / Art. 27 para. 3 IVDR (verification of registration)

To avoid unauthorized use of our CHRN, we’ll provide it only upon establishing our cooperation with you.

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