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January 9, 2026
Approximately 5 minutes
Swiss Single Registration Number (CHRN) for Medical Devices – Swissmedic Requirements
Swiss Single Registration Number (CHRN) for Medical Devices – Swissmedic Requirements
Introduction and Legal Basis
Since the entry into force of the revised Medical Devices Ordinance (MedDO) on 26 May 2021, economic operators placing medical devices on the Swiss market must obtain and use a Swiss Single Registration Number (CHRN). The CHRN serves as a unique identifier for manufacturers, authorised representatives, and importers, similar to the Single Registration Number (SRN) under the EU MDR/IVDR. It supports efficient market surveillance, traceability, and communication between Swissmedic and operators. The requirement aligns Switzerland's system with international standards while maintaining national oversight. CHRN – Swiss Single Registration Number - Swissmedic
Who Needs a CHRN
A CHRN is mandatory for:
- Manufacturers established in Switzerland placing their own devices on the market.
- Authorised Representatives designated by non-Swiss manufacturers for devices placed on the Swiss market.
- Importers bringing devices from abroad into Switzerland for distribution.
Economic operators established outside Switzerland who only export to Switzerland without placing devices on the market (e.g., pure exporters) are not required to obtain a CHRN.
Application Process
- Online Application: Requests are submitted exclusively via the Swissmedic portal (e-Business portal).
- Required Information: Company details, legal form, address, contact person, role (manufacturer/authorised representative/importer), and declaration of responsibility.
- No Fee: The assignment of a CHRN is free of charge.
- Processing Time: Swissmedic typically issues the CHRN within a few working days after validation of the application.
- Validity: The CHRN remains valid indefinitely unless changes (e.g., company name, address, legal form) require an update or re-application.
Use and Obligations
- Labelling and Documentation: The CHRN must appear on labels, instructions for use, declarations of conformity, and other relevant documents where the operator's identification is required.
- UDI Database (EUDAMED Equivalent): The CHRN is used for registration in the Swiss medical devices database and will be linked to future Swiss UDI/registration modules.
- Changes and Updates: Operators must promptly notify Swissmedic of any changes that affect the CHRN (e.g., address change, company restructuring) and may need a new CHRN in certain cases.
- Display in Public Register: Assigned CHRNs are listed in Swissmedic's public register of economic operators for transparency and verification.
Practical Guidance
Swissmedic provides detailed step-by-step instructions, FAQs, and a dedicated application form in the e-Business portal. Operators are encouraged to apply early to avoid delays in market placement. The CHRN replaces previous national registration numbers and ensures a single, consistent identifier across all relevant activities in Switzerland.
This mandatory registration system strengthens traceability and regulatory oversight of medical devices in Switzerland, supporting patient safety and efficient market surveillance. Full requirements, application links, and the public CHRN register are available on the Swissmedic website. CHRN – Swiss Single Registration Number - Swissmedic
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