Switzerland to accept Medical Devices with FDA approval

Good news for manufacturers who hold FDA clearance certificate for their medical devices and wants to enter Swiss market. On November 28, the Swiss parliament adopted its national laws, which allows medical devices with FDA approval in to the country.

Since 2001, Switzerland had the access to medical devices with EU certificate only. Post adoption, Swiss legislators can now recognize medical devices with FDA approval or clearance as well as CE marking.  According to Swiss MedTech, adopting these laws will create an opportunity in terms of better healthcare for Swiss patients. Also, the freedom of importing medical devices from EU and non EU countries.

Peter Biedermann, Managing Director of Swiss MeTech stated that “It is a response to circumstances that could no longer be ignored. Specifically, problems with the implementation of the new European medical device regulation and the negative consequences concerning availability, product range, and quality of medical devices throughout Europe’. Also he added “As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best.”

The main reason for Switzerland to take this decision is because of challenges experienced due to new EU MDR as well as its revised National Medical Device Ordinance which created more problems in Medical Device import. Swiss MedTech reports that, out of 500 foreign manufacturers, around 1000 have already stopped supplying products to Switzerland.

To conclude, it is a great sign for foreign manufacturers to enter Swiss market with ease. Also, this helps the Swiss patients to get better healthcare.