Product Registration Database for Medical Devices in Switzerland – Swissmedic Overview

Purpose and Legal Framework

The Product Registration Database is established under the revised Medical Devices Ordinance (MedDO), effective since 26 May 2021, to create a comprehensive register of medical devices available in Switzerland. It replaces previous notification systems and aligns with international practices (e.g., EUDAMED in the EU) while maintaining Swiss-specific requirements. The database supports Swissmedic in market surveillance, risk management, vigilance activities, and public information, ensuring traceability from economic operators to individual devices. Produktregistrierung - Swissmedic

Who Must Register and What

Mandatory registration applies to:

• Manufacturers (Swiss or foreign) placing devices on the Swiss market.
• Authorised Representatives for non-Swiss manufacturers.
• Importers introducing devices into Switzerland.
• Devices – All classes (I, IIa, IIb, III) and in vitro diagnostics, including custom-made and investigational devices under certain conditions.

Registrants must provide:

• Device identification (UDI-DI where applicable, or Swiss-specific identifiers).
• Economic operator details (including CHRN – Swiss Single Registration Number).
• Conformity assessment information (certificates, declarations).
• Labelling and instructions in required languages.

Registration Process

• Electronic Submission: All registrations are submitted exclusively via the Swissmedic e-Business portal.
• Steps:
  1. Obtain a CHRN (if not already held).
  2. Create or update operator profile.
  3. Register each device or device family with required data modules.
  4. Upload supporting documents (certificates, declarations, vigilance reports).
• Timelines: Registration must be completed before placing the device on the market; legacy devices follow transitional provisions.
• Fees: Certain registration activities incur fees as per Swissmedic tariff.

Database Content and Access

• Public Access: Limited public search available for basic device and operator information.
• Authority Access: Swissmedic uses the database for inspections, vigilance monitoring, and enforcement.
• Economic Operator Access: Registrants maintain and update their entries; changes (e.g., device modifications, operator details) require prompt notification.

Key Obligations and Consequences

• Updates: Any change affecting registered data (e.g., labelling update, certificate expiry, field safety corrective action) must be reported immediately.
• Vigilance Integration: Serious incidents and field safety notices are linked to registered devices.
• Non-Compliance: Failure to register, late updates, or provision of false information may result in market restrictions, recalls, or sanctions.

The Product Registration Database forms a cornerstone of Switzerland's medical device regulatory system, enhancing transparency, traceability, and patient safety. Detailed technical specifications, registration manuals, FAQs, and portal access are published on the Swissmedic website. Produktregistrierung - Swissmedic