Are you interested in obtaining authorization to sell your medical devices in Switzerland? If your company does not have a physical location in Switzerland, you are required to appoint an Authorized Representative, also referred to as Swiss Rep or AR, to represent your company to Swiss authorities. You must retain a Swiss AR as long as you sell your devices in that country.
What is the role of a Swiss AR?
Your AR serves as a liaison between you and the national competent authorities, for example, the Ministries of Health, and in accordance with Switzerland’s Medical Devices Ordinance (MedDO). Additionally, your appointed representative will:
- Assist with specific device registrations, as required.
- Be identified on your product labeling throughout Switzerland.
- Make a current copy of your regulatory documentation available upon request.
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting in cooperation with you and your distributors.
Appointing a distributor as your AR in Switzerland is a possibility; however, it is not recommended because most distributors are not prepared to fulfill the mandatory responsibilities of the Swiss AR. Instead, select an independent representative that focuses on regulatory affairs rather than sales and marketing.
Why choose Emergo by UL as your Swiss AR?
Emergo is the largest Authorized Representative for medical devices and IVDs, representing more than 1,000 device companies worldwide.
- Our experienced consultants will review your Technical File, register your medical device or IVD (from May 26, 2022), as required and respond to any questions or concerns from the competent authorities.
- You will have secure online access to all your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines and more.
- Our vast expertise with global regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
- We send frequent updates to all our AR customers with important regulatory updates.
- In addition to our Switzerland office, we maintain offices in the U.S., EU, U.K., Canada, Japan, South Korea, Brazil and many other locations worldwide. We can serve you efficiently regardless of your time zone.
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