Agreements on the mutual recognition of conformity assessments (MRAs):
Under such agreements, conformity assessments (test, inspections, certifications) that are carried out in a contracting party country are recognised in the other contracting party country. Switzerland has signed the following MRAs on medical devices with the following trade partners:
- Switzerland - EC
- Switzerland - EEA/EFTA countries (Norway, Iceland, Lichtenstein)
- Switzerland - Canada (non-operational)
Memorandums of Understanding (MoUs):
For the promotion of inter-governmental cooperation and as a confidence-building measure with a view to possiblity signing an MRA, medical device authorities from different countries can agree to sign a MoU. Swissmedic has signed just such an MoU with the US Food and Drug Administration (FDA) under which information-sharing between thes two authorities, in particular as regards market monitoring measures will be promoted.
The wording on this MoU can be found on the
website of the US Health Authority FDA.
Up to date information can be found on these agreements on the State Secretariat for Economic Affairs (seco)'s
website.
