Successful Product Registration in Switzerland
Switzerland is both a major manufacturing hub for medical devices and an important sales market for medical technology companies. However, the termination of the Mutual Recognition Agreement (MRA) with the EU in May 2021 has made Switzerland a “third country.”
Since then, placing medical devices on the market in Switzerland has entailed stricter requirements for manufacturers from the EU, as set forth in the Swiss Medical Devices Ordinance (MedDO). These include, among other things, various obligations for individual economic operators and the appointment of a Swiss authorized representative.
What makes our seminar unique?
In this interactive seminar, you’ll learn about the various requirements for economic operators dealing with medical devices in Switzerland. We’ll also use your products as examples to show you which specific aspects of the registration process need to be considered.
Numerous illustrative examples and practical tips will help you successfully register your product in Switzerland.
- Content
- Regulatory and Legal Requirements
- Organization of Swissmedic
- Overview of the HPA Legislation
- Local Representative
- Entry into the Swiss Market
- Product Classification
- Determining an Appropriate Registration Procedure
- Quality Management Requirements
- Regulatory and Legal Requirements
- Your Benefits
- You will learn about the various requirements for product approval in Switzerland.
- You will walk through the approval process using your product as an example during the seminar.
- You will receive practical solutions for your business.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Regulatory affairs professionals
- Quality management professionals
- Developers and manufacturers of medical devices
- Project managers
- Manufacturers and exporters of medical devices
