Regulations strongly influence Switzerland’s competitiveness as a medtech hub, Swiss Medtech emphasises. At the National Regulatory Conference organised by Swiss Medtech, over 450 industry representatives discuss how regulatory frameworks impact innovation, security of supply, and economic development.
Regulations must be effective, practical, and efficient – starting from initial authorisation of medical devices to climate protection and the use of artificial intelligence (AI). Unnecessary hurdles, on the other hand, drive up costs, delay market launches, and curb innovation.
Strengthen security of supply: remove regulatory barriers
Regulations must not always create new barriers. They can also remove existing ones. One example is the official recognition of medical devices: At the end of 2022, Parliament instructed the Federal Council to recognise devices approved by the US Food and Drug Administration (FDA) – in addition to those already certified in the EU. «Almost four years later, medtech companies and healthcare providers are still waiting for US-approved medical devices to be accepted in Switzerland too,» criticises Damian Müller, President of Swiss Medtech.
He appeals to the relevant authorities: «Use this mandate as an opportunity to strengthen patient care and make Switzerland a more attractive business location for the medtech sector. Switzerland could pioneer this approach in Europe.»
Swiss Medtech is campaigning for a streamlined and practical process. An additional, in-depth review of FDA-approved medtech products in Switzerland is unnecessary.
The bill must not become a paper tiger. A medical device that has been rigorously tested by the FDA and approved for 350 million people does not need a second round of authorisation in Switzerland
Adrian Hunn, Director of Swiss Medtech.
The FDA is one of the world’s strictest and most renowned regulatory authorities in the field of medical devices. The US is also the world’s largest medtech market.
Sustainability: CO₂ transparency as a competitive factor
Climate policy is also economic policy. Climate protection affects the entire medtech value chain – from raw material extraction through design and production to disposal, At the same time, pressure is mounting on companies to quantify their environmental footprint: legislators, investors and customers are increasingly demanding reliable environmental indicators. «Those who cannot provide this data will lose market share. This reality is nothing new,» says Adrian Hunn.
Swiss Medtech offers its members practical support in the form of a Sustainability Toolkit, which includes a guide designed specifically to help SMEs systematically reduce their CO₂ emissions and efficiently achieve the net-zero target. «We support our members where it counts for their business. Those who follow the guide consistently will strengthen their position in the face of international competition,» says Adrian Hunn.
Artificial Intelligence: Greater efficiency, lower regulatory strain
Artificial intelligence provides new avenues for Switzerland as a medtech hub to make regulatory processes more efficient and cost-effective. AI can save time and resources, particularly when it comes to processing regulatory requirements, documents, and data, as well as complex authorisation processes. «AI reduces the workload in areas where companies currently invest a great deal of time and resources. This will help free capacity for innovation,» says Adrian Hunn, Director of Swiss Medtech.
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