Frequently Asked Questions

Your company is subject to the obligations of both the CH-REP and CH-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.

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

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

• 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 (Swiss Authorised Representative): A legal entity based in Switzerland that acts as the authorised representative for non-Swiss manufacturers of medical devices and IVDs. The CH-REP ensures compliance with Swiss regulations and acts as a point of contact for Swiss authorities. Think of it as your legal representative in Switzerland.

• CH-Importer: An entity registered with Swissmedic as an importer of medical devices and IVDs into Switzerland. Non-Swiss manufacturers or distributors are typically required to use a CH-Importer to legally bring their products into the Swiss market. Your gateway for importing products into Switzerland.

• Swissmedic: The Swiss Agency for Therapeutic Products. It is the Swiss national authority responsible for the authorisation and supervision of therapeutic products, including medical devices and IVDs. The Swiss equivalent of the FDA or EMA.

• MedDO (Medical Devices Ordinance): The Swiss ordinance regulating medical devices. It sets out the requirements for placing medical devices on the Swiss market. The main rulebook for medical devices.

• IvDO (In Vitro Diagnostic Medical Devices Ordinance): The Swiss ordinance regulating in vitro diagnostic medical devices. It sets out the requirements for placing IVDs on the Swiss market. The rulebook specifically for IVDs.

• MDR (Medical Device Regulation (EU) 2017/745): The European Union regulation for medical devices. While Switzerland is not part of the EU, the MDR has implications for products sold in Switzerland due to mutual recognition agreements. An important EU regulation that also impacts Switzerland.

• IVDR (In Vitro Diagnostic Medical Device Regulation (EU) 2017/746): The European Union regulation for in vitro diagnostic medical devices. Similar to the MDR, it also has implications for products sold in Switzerland. An important EU regulation impacting IVDs in Switzerland.

• CHRN (Individual Swiss Registration Number): A unique registration number assigned by Swissmedic to each manufacturer, importer, or representative registered in Switzerland. Your official identification number with Swissmedic.

• Conformity Assessment: The process of demonstrating that a medical device or IVD meets the applicable regulatory requirements. This may involve testing, documentation, and audits. Proving your product meets the standards.

• Declaration of Conformity: A document signed by the manufacturer declaring that their medical device or IVD meets the applicable regulatory requirements. Your formal statement of compliance.

• Authorised Representative (See CH-REP): In the context of Swiss regulations, this refers to the legal entity based in Switzerland that represents a non-Swiss manufacturer.

• Vigilance System: A system for reporting and investigating adverse events or incidents involving medical devices and IVDs. Ensuring the safety of products on the market.

• Market Surveillance: Activities carried out by Swissmedic to monitor the safety and performance of medical devices and IVDs on the Swiss market. Swissmedic's ongoing monitoring of product safety.

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.

• 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.

• Art. 53 MedDQ, Art. 46 IvDQ

• Art. 13 MDR, Art. 13 IVDR

• Art. 55 para. 3 MedDQ / Art. 30 para. 3 MDR or Art. 46 para. 3 IvDQ / Art. 27 para. 3 IVDR (verification of registration)

We'll provide you our CHRN only after establishing our cooperation with you to avoid unauthorized use of our CHRN.