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Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement

Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is "Service Agreement Export Certificates MEP".

Export certificates (Free Sales Certificates (FSC)) certify the formal conformity of the medical devices in question with the legal requirements in Switzerland and thus their basic eligibility for being marketed at the time the certificate is issued.


Swissmedic issues export certificates for medical devices. The export certificate guidance details How to obtain an export certificate, the Language used on export certificates, Processing periods, fees, etc.


In order to place medical devices on the European market, Swiss manufacturers and Swiss authorised representatives must submit the necessary documentation in order for Swissmedic to issue export certificates. Swiss manufacturers need an authorised representative/importer in the EU.


In some countries, CE conformity markings are not recognized and export certificates must be issued by the competent national authority in the country where the exporting company or production facility is located in order to register and place medical devices on the market, such as Peru, Brazil, China, Japan, India, Indonesia, Saudi Arabia, Egypt.


Basically, this is a service agreement that describes the services the Swiss Agency for Therapeutic Products (Swissmedic) provides, including entitlements and obligations for those who use this service, as well as the services the Swiss Agency for Therapeutic Products (Swissmedic) offers.


In addition, the guidance describes how to obtain an export certificate, what supporting documents are required, what types of certificates are available, what language is used on export certificates, and how fees are calculated.


If you are interested to know more in detail about the Services, entitlements and obligations of the Agency, Obligations and responsibilities of the beneficiaries, Fees, payments etc click this LINK.


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