By Stewart Eisenhart, Emergo Group
Emergo Group
FDA pilot program for medical device review tool development in the works
By Stewart Eisenhart, Emergo Group
A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications.
US regulators to exempt some Class I and II medical devices from 510(k) premarket review
By Stewart Eisenhart, Emergo Group
Further analysis of new Chinese medical device registration requirements
By Stewart Eisenhart, Emergo Group
Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process.
New Chinese medical device, IVD regulations take effect in October 2014
By Stewart Eisenhart, Emergo Group
Chinese medical device market regulators have published long-awaited updates to medical device as well as in vitro diagnostic device and labeling requirements that will go into force October 1, 2014.
Revised medical device definitions implemented in New Zealand
By Stewart Eisenhart, Emergo Group
New Zealand medical device and drug market authority Medsafe has updated its process for defining medical devices and pharmaceutical products as part of an ongoing merger with the Australian Therapeutic Goods Administration.
Japanese regulators announce enforcement date for new medical device and drug laws
By Stewart Eisenhart, Emergo Group
The Japanese government has set an enforcement date (link in Japanese) of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets.
US legislators again propose broader Medicare coverage for telehealth
By Stewart Eisenhart, Emergo Group
CMS propose 4 changes which could mean major new costs for medical device makers | Regulatory news for the week of July 28, 2014
European regulators issue guidance on nanotechnology in medical devices
By Stewart Eisenhart, Emergo Group
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
Russian regulators preparing new medical device classification system?
By Stewart Eisenhart, Emergo Group