swissmedic

Please note this is an extract of the original bulletin. Go-live for the swissdamed Actors module Since 26 May 2021, Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN). The Actors module of swissdamed will be available from 6 August 2024. After…

Please note this is an extract of the original bulletin. swissdamed – Swiss Database on Medical Devices The “going-live” date being deferred to the 2nd half of 2024

Please note this is an extract of the original bulletin. Devices manufactured and used in healthcare institutions General information and notes on in-house devices according to MedDO and IvDO New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices…

Please note this is an extract of the original bulletin. New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)

Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…

Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.

Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…