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 wanted to conclude an agreement with a foreign dealer and manufacturer of a product for the import of a medical device into Switzerland. We assisted the distributor in negotiating the contract for this international business relationship, taking into account the pitfalls of a cross-border agreement.
During the negotiations, it was determined that fulfilling certain regulatory product requirements was time-consuming. As the product launch was imminent, the product was placed on the market. The risks associated with the import were considered to be manageable.
The product was stopped at the border and assessed by the competent authority. Based on the data made available to it, the authority initially came to the conclusion 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, which was submitted together with the legal argumentation presented, 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 its product and the manufacturer gained the necessary time to adapt its products to the new requirements.