The Swiss medical device regulatory authority, ’swissmedic‘ recently, registered economic operators were reminded to register in the database by the 13th of November 2024 in the swissdamed database.
This does not affect the manufacturers from whom we have a CH-REP mandate. It only affects Economic Operators, who are resident in Switzerland.
In August 2024, all economic operators registered with a CHRN (Swiss Single Registration Number) at Swissmedic were asked by letter to their contact person to validate the data migrated to swissdamed within a period of three months. Almost 1,000 operators have already validated their data. The deadline is 13th November 2024. It is recommended that you start the data validation immediately to ensure a smooth process.
Please note that the validation process consists of two steps:
- The first step is to review the company data.
- The second step is to check the data of each registered participant. The detailed instructions for this procedure can be found in the link below. It is strongly recommended that you complete steps 1–5 in full.
Further details can be found here.
As a registered economic operator, you are obliged to validate your data. By doing so, you are making an important contribution to the data integrity and timeliness of the Actors module of swissdamed. This is an essential basis for the smooth introduction of the Devices module and, ultimately, for the overview of the Swiss medical device market.
Are you a manufacturer not based in Switzerland or Liechtenstein and do you export products to Switzerland?
Contact us for the CH-REP-Service at fair conditions!
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