Regulatory Blog

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...

The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...

On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...

Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...

On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...

This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...