India: CDSCO Secures IMDRF Affiliate Membership
In a major step towards strengthening its medical device regulatory framework, India’s Ministry of Health and Family Welfare has...
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ARQon
Dec 4, 20191 min read
Global Interest News Updates - Nov/Dec 2019
AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are...
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ARQon
Aug 30, 20191 min read
Global Interest News - Aug 2019
IMDRF: Guidance drafted on regulatory pathways for personalised medical devices IMDRF: Comments solicited on terminologies for...
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ARQon
Jun 28, 20191 min read
Global Interest News - Jun 2019
EU/US: Cooperation on development of UDI database specifications IMDRF: Assembly and technical guide for IMDRF ToC submissions IMDRF:...
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ARQon
May 30, 20191 min read
IMDRF Clinical Documents for Public Consultation
The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...
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ARQon
Mar 29, 20191 min read
Global Interest News - Mar 2019
IMDRF: Optimising standards; Essential Principles; personalised medical devices ISO: Third edition of ISO 14155 on clinical...
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ARQon
Sep 4, 20181 min read
Global Interest News - Aug/Sep 2018
IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI ISO: Latest revisions of ISO...
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ARQon
Aug 30, 20181 min read
Singapore incorporated IMDRF Essential Requirements including Cybersecurity
Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity. The new version Essential Requirements (ER)...
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ARQon
May 23, 20181 min read
Global Interest News - May 2018
IMDRF: Final guidance documents published IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices...
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ARQon
Feb 2, 20181 min read
Global Interest News - February 2018
IMDRF: Essential Principles of safety and performance of medical devices and IVDs Click here for the full article on Global Regulatory...
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ARQon
Jan 1, 20181 min read
Global Interest News - December 2017
IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data ISO: New handbook on medical...
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