In a major step towards strengthening its medical device regulatory framework, India’s Ministry of Health and Family Welfare has...

AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are...

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:...

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...

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

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

Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity. The new version Essential Requirements (ER)...

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...