top of page
Search
ARQon
Oct 15, 20241 min read
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...
7 views0 comments
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...
24 views0 comments
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...
15 views0 comments
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:...
12 views0 comments
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...
43 views0 comments
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...
14 views0 comments
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...
16 views0 comments
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)...
49 views0 comments
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...
10 views0 comments
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...
27 views0 comments
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...
16 views0 comments
bottom of page