Answers to frequently asked questions about CH-REP (Swiss Authorised Representative) and CH-Importer (Swiss Importer) requirements for medical devices and IVDs in Switzerland.
If your company is established in Switzerland and imports medical devices or IVDs from another country for placement on the Swiss market, it acts as a Swiss Importer and is subject to the applicable importer obligations.
A Swiss Importer does not automatically act as the manufacturer’s CH-REP. The CH-REP role requires a separate written mandate from the foreign manufacturer. If the same company acts as both Swiss Importer and CH-REP, both roles must be registered separately and separate CHRNs are issued.
No. If you act in the same economic operator role for both medical devices and IVDs, one registration is sufficient. You do not need a separate CHRN for medical devices and IVDs.
However, if your company performs more than one role – for example, acting as both CH-REP and Swiss Importer – each role requires a separate registration and a separate CHRN.
Private individuals selling medical devices or IVDs are subject to the same regulatory obligations as other importers or distributors, depending on their role in the supply chain.
If you import devices from abroad and place them on the Swiss market, Swiss Importer requirements may apply. If you only distribute devices already placed on the Swiss market, distributor obligations apply.
The main legal framework for medical devices and IVDs in Switzerland includes:
Therapeutic Products Act (TPA; SR 812.21) – the overarching Swiss law for therapeutic products.
Medical Devices Ordinance (MedDO; SR 812.213) – the main ordinance for medical devices.
Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) – the corresponding ordinance for IVDs.
EU MDR 2017/745 and EU IVDR 2017/746 – important reference frameworks because Swiss medical device legislation remains closely aligned with the EU regulatory system.
CH-REP, Swiss Importer and distributor obligations are primarily defined by the Swiss MedDO and IvDO.
CH-REP (Swiss Authorised Representative): A person or legal entity established in Switzerland and formally mandated by a non-Swiss manufacturer to represent it for specified regulatory obligations under Swiss medical device law.
Swiss Importer (CH-Importer): An economic operator established in Switzerland that places a medical device or IVD from another country on the Swiss market. The importer has specific verification, traceability and post-market obligations.
Swissmedic: The Swiss Agency for Therapeutic Products and the competent Swiss authority responsible for medical device market surveillance, economic operator registration and the swissdamed medical device database.
MedDO (Medical Devices Ordinance): The Swiss ordinance governing medical devices and defining requirements for manufacturers, CH-REPs, importers, distributors and other economic operators.
IvDO (Ordinance on In Vitro Diagnostic Medical Devices): The corresponding Swiss ordinance governing in vitro diagnostic medical devices (IVDs).
MDR – Regulation (EU) 2017/745: The European Union Medical Device Regulation. Swiss medical device legislation is closely aligned with many requirements of the EU MDR.
IVDR – Regulation (EU) 2017/746: The European Union regulation governing in vitro diagnostic medical devices. Swiss IVD legislation is similarly aligned with many IVDR requirements.
CHRN (Swiss Single Registration Number): A unique registration number assigned to an economic operator by Swissmedic. Separate CHRNs are required where the same organisation performs different registered economic operator roles.
swissdamed: The Swiss database for medical devices and economic operators, operated by Swissmedic. It is used for actor registration, device registration and importer-device linking.
Conformity Assessment: The process used to demonstrate that a medical device or IVD meets the applicable regulatory requirements.
Declaration of Conformity: The manufacturer's formal declaration that a device complies with the applicable regulatory requirements.
Vigilance: The system for reporting, assessing and managing serious incidents and safety-related corrective actions involving medical devices and IVDs.
Market Surveillance: Activities performed by Swissmedic to monitor compliance, safety and performance of medical devices and IVDs on the Swiss market.
Note: This glossary is intended for informational purposes only and does not constitute legal advice. Please consult with a regulatory expert for specific guidance on your situation.
The CHRN (Swiss Single Registration Number) is assigned by Swissmedic to registered economic operators in Switzerland. Separate CHRNs apply to different roles, such as CH-REP and Swiss Importer. To prevent misuse, we provide the relevant CHRN to customers once our cooperation has been established.
The legal basis for the Swiss Authorised Representative (CH-REP) is primarily set out in Art. 51 and 52 of the Swiss Medical Devices Ordinance (MedDO) for medical devices and Art. 44 and 45 of the IvDO for in vitro diagnostic medical devices. These provisions define the appointment and obligations of the CH-REP in Switzerland.
The corresponding authorised representative requirements in the EU MDR and IVDR are set out in Article 11.
The legal basis for the Swiss Importer (CH-Importer) is primarily set out in Art. 53 of the Swiss Medical Devices Ordinance (MedDO) for medical devices and Art. 46 of the IvDO for in vitro diagnostic medical devices. These provisions define the obligations of importers established in Switzerland.
The corresponding importer obligations under the EU MDR and IVDR are set out in Article 13. Importers must also verify the applicable economic operator registration requirements under Art. 55 para. 3 MedDO / Art. 30 para. 3 MDR and Art. 48 para. 3 IvDO / Art. 27 para. 3 IVDR.
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