IMDRF: Guidance drafted on regulatory pathways for personalised medical devices IMDRF: Comments solicited on terminologies for...

EU/US: Cooperation on development of UDI database specifications IMDRF: Assembly and technical guide for IMDRF ToC submissions IMDRF:...

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...

IMDRF: Optimising standards; Essential Principles; personalised medical devices ISO: Third edition of ISO 14155 on clinical...

The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the...

IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI ISO: Latest revisions of ISO...

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing...

IMDRF: Final guidance documents published IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices...

IMDRF: Essential Principles of safety and performance of medical devices and IVDs Click here for the full article on Global Regulatory...

IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data ISO: New handbook on medical...