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Switzerland's SwissMedic: Guidance on Export Certificates

On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory framework, this guidance provides details on export certificates for medicinal products, outlining the requirements and procedures for obtaining these certificates.

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. Swissmedic can issue export certificates to manufacturers and Swiss authorised representatives based in Switzerland if they submit the necessary documentation.

Swissmedic, the Swiss Agency for Therapeutic Products, issues export certificates (Free Sales Certificates, FSC) for medical devices exported to third countries based on the Therapeutic Products Act (TPA), the Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices Ordinance (IvDO).

If Swiss manufacturers want to sell medical devices in the EU, they must have an authorized representative/importer. Some countries do not recognize CE conformity markings and require export certificates 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. These countries include Peru, Brazil, China, Japan, India, Indonesia, Saudi Arabia, Egypt etc.

Swissmedic issues export certificates for medical devices such as Products, including instruments, apparatus, devices, in vitro diagnostics, software, implants, reagents, materials and other goods or substances which are intended to have, or are presented as having, a medical use and whose principal effect is not obtained with a medicinal product.

Products with a non-medical intended use according to Annex I of MedDO are also deemed to be medical devices. A Swissmedic export certificate is issued for a medical device that is formally compliant with Swiss law and may in principle be placed on the Swiss market without restriction based on the documents submitted. Swissmedic does not issue export certificates for components of medical devices, only for their final products.

To know more about how to obtain an export certificate, the types of certificate, supporting documents for CE conformity click this LINK.


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