Swissmedic has added important functions to the product registration module in swissdamed.
Manufacturers, Swiss authorised representatives (CH-REP) and those who assemble systems and treatment units now have new options for registering medical devices in the UDI Devices module. An online editor for manual data entry and a machine-to-machine (M2M) interface for automated data transfer are now available.
This expansion affects key processes in swissdamed product registration and offers greater flexibility for companies of different sizes and with varying volumes of data.
New Options for Product Registration in Swissdamed
With these new features, companies will in future be able to register their product data in two ways:
- manually via an online editor
- automated via an M2M interface (REST API, JSON format)
This will bring UDI registration in Switzerland more closely into line with manufacturers’ practical requirements.
Online Editor: Simple Swissdamed Registration with no Technical Hurdles
The new online editor allows products, systems and treatment units to be entered directly into swissdamed. The application guides users step by step through all the required fields.
The solution is particularly suitable for:
- Companies with a small or medium-sized product portfolio
- Manufacturers without technical interfaces (XML / API)
- Users who only occasionally register products in the system
The online editor offers a straightforward way to get started with registering medical devices on swissdamed, without the need for additional IT infrastructure.
M2M Interface: Automated UDI Registration for Large Volumes of Data
For companies with extensive product portfolios, Swissmedic also provides an M2M-Schnittstelle . Product data can be automatically transferred to Swissmedic in JSON format via a REST API.
The M2M solution is particularly suitable for:
- Manufacturers with a large number of products and a high data frequency
- Companies with existing PIM or ERP systems
- Technical teams or specialist service providers
Important: Swissmedic recommends testing the implementation first in the provided playground. This allows errors in data transmission to be identified at an early stage and avoids additional work in the live system.
Greater Flexibility in Swissdamed Product Registration
With the online editor and the M2M interface, two complementary options are available. Companies can choose the solution that best suits their internal structure and data volume.
This makes swissdamed UDI registration significantly more flexible and scalable.
Help with Registering for Swissdamed
The new features simplify the technical aspects of registration, but do not alter the regulatory requirements for medical devices in Switzerland. A correct and complete data set remains crucial.
As a Swiss authorised representative (CH-REP), BEO BERLIN, in collaboration with Albo-Healthcare , assists manufacturers with swissdamed product registration. This support includes, amongst other things
- Support with registration in the UDI Devices module
- Advice on selecting the appropriate registration method (online editor vs. M2M)
- Support with swissdamed registration as a CH-REP, particularly for manufacturers without an M2M connection: structured data import (CSV/CCV export), processing within the tool and creation of XML files for upload to EUDAMED and swissdamed, as well as ongoing support throughout the registration process; suitable for small to medium-sized product portfolios (up to approx. 100 products)
- Regulatory assessment and CH-REP support for the Swiss market
- Support with product registration (with Master UDI-DI)
Conclusion: Greater Efficiency in UDI Registration in Switzerland
With these new features, swissdamed is evolving into a more flexible system for product registration. Companies benefit from a clear choice between manual entry and automated data transfer.
It is worthwhile for manufacturers to assess at an early stage which registration route best suits their own structure and how swissdamed registration of medical devices can be efficiently integrated into existing processes.
Do you need support with swissdamed registration or are you looking for a CH-REP for Switzerland? BEO BERLIN and Albo-Healthcare will be happy to assist you with the implementation. Please feel free to contact us.
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