The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.
4 of them are relating to Basic UDI-DI, which manufacturers can use to
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ICH guidelines Q12, E9(R1) and M9 adopted following assembly in Singapore
International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step 4 of the ICH process were adopted to promote innovation
read more...Vietnam, New Feature on Registration System VNSW
Vietnam Ministry Of Health has introduced a new feature on their registration website system VNSW on 29th October 2019.
This new feature combines 2 registration both import and product license in
read more...European Commission released an aide memoire on practicing good distribution practice (GDP)
The European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP).
The 6 page document ranges from a form of general questions to specific questions
read more...Eudamed upcoming plans
The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.
They have decided to launch
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