Mutual Recognition Agreements

Mutual Recognition Agreements (MRAs) on conformity assessments constitute a significant trade policy instrument within the framework of the World Trade Organization (WTO) that are intended to overcome technical obstacles to trade in the state-regulated sector. In contrast to information exchange agreements, MRAs permit the products concerned to be placed on the market in Switzerland and the territory of the contracting party with as few obstacles as possible.

In those product areas in which the applicable legislation in Switzerland and the contracting party is considered to be equivalent, an MRA makes it possible to carry out conformity assessments and mutually recognise conformity assessment bodies (CABs) in accordance with the technical regulations of the contracting parties so that products can be placed on the market without further controls.

For medicinal products that come under the signed MRA, the contracting parties each recognise the results of GMP inspections of the manufacturer performed by the responsible inspectorates of the other contracting party and the manufacturing authorisations issued by the responsible authority of the other contracting party. This includes each contracting party recognising the results of inspections of manufacturers in third countries performed by the responsible inspectorate of the other contracting party.

The State Secretariat for Economic Affairs is the lead entity for this type of agreement in Switzerland.

At present, MRAs exist between Switzerland and the following countries or institutions:

Beetween Title In force since Link
Switzer-
land -
Canada
MRA Switzerland - Canada 1 May 1999 CC 0.946.523.21
Switzer-
land -
EU
Agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments
(Chapter 4 on medical devices, valid until the entry into force of the EU-IVDR of 26 May 2022)
1 June 2002 CC 0.946.526.81
Switzer-
land -
EEC / EFTA states
Agreement on the establishment of the European Free Trade Association (EFTA) 1 June 2002 CC 0.632.31
https://www.swissmedic.ch/content/swissmedic/en/home/about-us/international-collaboration/bilateral-collaboration-with-partner-authorities/mutual-recognition-agreements.html