In November, Swiss Medtech, the Swiss Medical Technology Association, held talks with the authorities on the import of legacy medical devices.
On 16 November, Swiss Medtech met with the Directorate of the Federal Office of Public Health (FOPH) and the Directorate of the supervisory authority Swissmedic to personally explain the demands submitted in writing in connection with the Medical Devices Ordinance (MedDO) and the great concern regarding the emerging supply problems. Swiss Medtech regrets that it was unable to report a positive outcome to the talks.
The authorities have communicated their position that
- there is no legal uncertainty for the medtech sector,
- the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) is no longer applicable,
- here is a legal basis for the required labelling of legacy medical devices ((Medical Device Directive), and
- they see no reason to remove existing import barriers as a precautionary measure to ensure the availability of medical devices .
Das BAG und die Swissmedic vertreten die Position, dass die Benennung eines Schweizer Bevollmächtigten (CH-REP) sowie das Labelling von CH-REP und Importeur Voraussetzungen für das Inverkehrbringen von importierten Medizinprodukten sind.
Swiss Medtech s the Swiss medical technology association representing more than 700 companies.
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