Medical Devices EU regulations for MDR – Part 1

Medical Devices EU regulations for MDR – Part 1

Sep 3, 2021 | Serialization

Introduction The EU MDR is a new set of regulations that came into effect on 26th May 2021, following a 4-year transition period after being adopted in May 2017. It aims to improve the safety and performance of the device throughout the lifecycle by tightening up the...
SFDA Dossier requirements

SFDA Dossier requirements

Aug 27, 2021 | Serialization

  The SFDA Dossier requirements differ for each application. What is important to note is that the CTD provides a format for an MAA (Marketing Authorization Applcication) Also to be noted is that regional and national requirements may affect the content of a...