Frequently Asked Questions on the Swiss Medical Devices Database – Swissmedic Guidance

Overview of the FAQ Section

The FAQ page provides detailed, practical answers to the most frequently asked questions regarding the Swiss medical devices database (Product Registration Database). It covers registration processes, required data elements, technical specifications, responsibilities of economic operators, and troubleshooting common issues. The content is regularly updated to reflect changes in MedDO requirements, portal functionality, and user feedback. This resource is essential for manufacturers, authorised representatives, importers, and other stakeholders ensuring compliance when placing devices on the Swiss market. FAQ – Swissmedic Medical Devices Database

Main Categories Covered

The FAQs are organised into key topics, including:

• General Questions – Purpose of the database, legal basis (MedDO), who must register, and timelines.
• Access and Portal – How to obtain e-Business access, login issues, password reset, and multi-user management.
• CHRN (Swiss Single Registration Number) – Application process, validity, updates, and use in labelling/documentation.
• Device Registration – What to register (devices, families, accessories), mandatory fields, UDI integration, and legacy device rules.
• UDI Implementation – Assignment of UDI-DI/PI, compatible issuing agencies, barcode standards, and presentation on labels/packaging.
• Data Submission and Validation – File formats, upload limits, error messages, and correction procedures.
• Updates and Changes – Notification obligations for modifications, certificate expiry, ownership transfer, and vigilance linkage.
• Public Register and Transparency – What information is publicly visible, search functions, and data protection.
• Technical Support – Contact points, response times, test environment (Playground), and known issues.

Selected Key Questions and Answers

• Who is required to register devices?
  Manufacturers placing devices on the Swiss market, authorised representatives for foreign manufacturers, and importers must register. Pure exporters without Swiss market placement are exempt.

• Is registration free?
  Basic registration is free, but certain advanced services or late submissions may incur fees per the Swissmedic tariff.

• What happens if I miss the registration deadline?
  Non-registration prevents legal market placement; Swissmedic may impose restrictions, require immediate action, or initiate enforcement measures.

• How do I correct errors after submission?
  Use the portal's amendment function; significant changes require justification and may trigger re-assessment.

• Do I need UDI for all devices?
  Yes, for most devices (phased by class); exceptions include certain low-risk custom-made and investigational devices.

• Can foreign operators use the same CHRN in multiple countries?
  No, CHRN is Switzerland-specific; foreign operators must obtain a Swiss CHRN via an authorised representative.

Practical Benefits

The FAQ reduces the need for direct inquiries, speeds up compliance preparation, and minimises registration errors. It includes screenshots, step-by-step guides, links to forms/templates, and references to related guidance documents. Users are encouraged to consult the FAQ first before contacting support.

This resource supports transparent and efficient implementation of the Swiss medical devices database obligations, contributing to improved traceability, market surveillance, and patient safety. The full list of questions, answers, and updates is continuously maintained on the dedicated Swissmedic FAQ page. FAQ – Swissmedic Medical Devices Database