On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export certificates for medical devices.
Export certificates 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.
Swiss manufacturers need to have an authorised representative/importer in the EU in order to place medical devices on the EU market.
Certain countries do not recognise CE conformity marking and require export certificates issued by the competent national authority in the country where the exporting company or the production facility is based for the registration and placing on the market of medical devices.
These countries include Peru, Brazil, China, Japan, India, Indonesia, Saudi Arabia, Egypt etc.
Swissmedic can issue those certificates to manufacturers and authorised representatives located in Switzerland, provided they supply the required supporting documentation. Swissmedic does not issue export certificates to companies located outside Switzerland.
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