Import of medical devices
When negotiating contracts between manufacturers and distributors, it is necessary to check the available certificates for medical devices for accuracy. Good contractual relationships between trading partners can only be achieved through knowledge of the potential risks associated with the regulatory requirements.
A Swiss distributor wished to conclude an agreement with a foreign trader and manufacturer for the import of a medical device into Switzerland. We supported the distributor in negotiating the contract for this international business relationship, taking into account the pitfalls inherent in a cross-border agreement.
During the negotiations, it became apparent that fulfilling certain regulatory product requirements would be onerous. As the product launch was imminent, the product was placed on the market, and the risks associated with the import were assessed as manageable.
At the border, the product was stopped and assessed by the competent authority. Based on the data provided, the authority initially concluded that the product could not be placed on the market. It granted the right to be heard. After we, together with the manufacturer and the importer, provided additional documentation and submitted it together with our legal arguments, the authority refrained from taking further measures and allowed the medical device to be placed on the market. This ensured that the client was able to successfully launch their product and that the manufacturer gained the time needed to adapt its products to the new requirements.