Swissdamed Registration for Medical Devices and IVDs in Switzerland
Ensure your medical device or IVD is fully compliant with Swiss regulations by completing accurate and up-to-date Swissdamed registration.
Swissdamed Registration for Compliance and Market Access
The Swissdamed registration module is not yet live, and the Swiss Medical Device Registration process is still in development. While registration is mandatory under the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Devices Ordinance (IvDO), manufacturers should be prepared for the system’s official rollout and stay informed on updates from Swissmedic.
Swissdamed is a key database for the medical device and IVD market in Switzerland. It allows manufacturers to register their products and the organizations involved in the Swiss device market. Registration in Swissdamed is a mandatory requirement under the Swiss Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Devices Ordinance (IvDO), following Switzerland’s adoption of EU medical device regulations. Ensuring your Swissdamed registration is accurate and up-to-date is essential to comply with regulatory standards and to ensure smooth market access.
What Does Swissdamed Registration Mean for Manufacturers?
Actor registration
Manufacturers must first register as an “Actor” in Swissdamed. This registration needs to be completed before you can begin registering your devices in the system. The registration must be reviewed and approved by the Swiss Competent Authority (Swissmedic) before it can go live.
The deadline for validation of actor data in Swissdamed was 13 November 2024. All new actors must register via Swissdamed to comply with Swiss regulations. As the mandatory registration deadline approaches, delays in registration approval can occur. To avoid compliance risks, it is crucial to complete the registration process ahead of time.
Device/UDI registration
Once your Actor registration is live, you can proceed to register your devices in Swissdamed. Device registrations are required to meet the Swiss regulatory requirements and may involve obtaining Unique Device Identifiers (UDIs). The registration process can be time-consuming, especially if your company has a large portfolio of devices. You’ll need to gather all relevant device details and characteristics to ensure complete and compliant registrations.
The “Devices” module in Swissdamed will go live in several phases. After the first release in 2025, it will be possible to register certain devices following XML files in EUDAMED format. By 1 July 2026, all devices must be registered in Swissdamed. Manufacturers or Authorized Representatives (ARs) have until 31 December 2026 to complete device registrations. If a serious incident, a Field Safety Corrective Action (FSCA), or trend needs to be reported to Swissmedic, immediate registration will be required starting from 1 July 2026.
Maintain EUDAMED registrations
Swissdamed registration is not a one-time process. You must keep your registrations up to date and manage new device registrations as necessary, especially when significant changes are made to your products. Swissdamed’s interface and data requirements will continue to evolve, so it’s crucial to stay informed about updates and ensure your records are maintained accurately and in compliance with Swiss regulations.
Swissdamed registration is simple with MedEnvoy
MedEnvoy can support you in ensuring your Swissdamed registration process is smooth, efficient, and compliant. With our deep regulatory expertise and technical solutions, we can handle your initial Swissdamed registrations and maintain them throughout the lifecycle of your devices. We also provide ongoing support to ensure you meet the evolving requirements of Swiss regulations.
How we can help:
Outsource a tedious registration process
Our team specializes in managing Swissdamed registrations. We ensure that all required device information is accurately uploaded into the Swissdamed system. We’ll help you register your company as a legal manufacturer, manage the registration of your devices at the UDI-DI level, and assist you in obtaining your Swiss Registration Number (SRN). With our expertise, we simplify the process and reduce the burden on your internal resources.
Streamline data management
MedEnvoy’s integrated services, including Swiss Authorized Representation (CH REP) and Regulatory Importer services, allow us to offer a streamlined approach for managing your device registrations. By using a single set of data and documentation across these services, we help reduce administrative costs and ensure consistency across your regulatory filings.
Leverage our custom tool, GloRIAS
MedEnvoy’s proprietary cloud-based platform, GloRIAS, streamlines the Swissdamed registration process by offering efficient data transfer and document sharing. We ensure that your Swissdamed registration information is complete and up-to-date, and we will assist with any ongoing updates and new device registrations. Your dedicated account manager will work closely with you to keep your registration information accurate.
Access our regulatory experts
Our team of Regulatory Affairs experts is always available to provide advice and assistance. We keep you informed about relevant regulatory updates and developments through our regular communications. You will also have access to our regulatory resources and newsletter, ensuring you stay ahead of changes that could impact your registrations.