Are you unsure what requirements you need to meet as an importer? Here you can get all the information.
Are you unsure what requirements you need to meet as an importer? Here you can get all the information.
General requirements
As an importer of medical devices in Switzerland, you must comply with the applicable legal guidelines and requirements. The most important regulations include the Medical Devices Ordinance (MPV) and the Ordinance on the Recording, Assessment and Compensation of Damages in Connection with Medical Devices (MepV). In addition, you must ensure that the products you import meet the CE marking and comply with the relevant European standards and directives.
Quality management system
As an importer, you are also required to implement a quality management system implement and maintain a system that ensures that the products you import comply with applicable requirements. In addition, you need to make sure you have adequate liability insurance to cover any potential damages.
It is also important to note that as an importer, you are responsible for the safety of the products responsible for the products you bring to the Swiss market. If a medical device you import has a safety problem, you are required to report it to the authorities immediately and take appropriate action to correct the problem.
Overall, as an importer of medical devices in Switzerland, you must ensure that you comply with applicable regulations and requirements to ensure that the products you import are safe and effective and meet the requirements of the Swiss regulatory authorities.
Regulations as importer
In order to operate as an importer of medical devices in Switzerland, various regulations and requirements must be met. These include:
- Registration with the Swiss Agency for Therapeutic Products Swissmedic as an importer of medical devices.
- Compliance with the requirements of the Swiss Medical Devices Ordinance (MepV) and the European Medical Devices Regulation (MDR).
- Ensure compliance of imported medical devices with MepV and MDR requirements.
- Documenting the compliance of imported medical devices and conducting risk assessments.
- Compliance with the requirements for handling personal data in the context of import activities.
Overview of the requirements to be met as an importer.
More information
In addition, depending on the type and intended use of the imported medical devices, further regulations and requirements may arise, for example with regard to the safety and efficacy of the products. It is therefore important to obtain in-depth information on the applicable regulations and requirements before engaging in import activities, and to consult external experts if necessary.
Do you have further questions about the applicable regulations and requirements? tradee.ch is your competent partner for regulatory and quality assurance matters in the area of direct and parallel import with a focus on the Swiss market…. Our team is at your side to support you in complying with the applicable regulations efficiently and reliably
You can also find more information about the specifications and requirements of direct import here:
What are the obligations of a Swiss importer?
