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Heath Canada intends to begin piloting the use of its Regulatory Enrollment Process through the Common Electronic Submission Gateway for medical device applications by this summer. Read More
New draft regulation spells out qualification requirements for medical reps, including a two-year junior college degree or higher with a major in life sciences. Read More
A revision was made with the goal of striking a balance between transparent interactions and the need for healthcare professionals to “make independent decisions regarding patient care and treatment.” Read More
A new IVD application for priority review status should include a justification for how early market availability in the country will result in improved health. Read More
The South Korean government reached an agreement with the nation’s medical device industry to adopt accelerated approval procedures for certain devices. Read More
Member medical device companies at four of the top industry trade associations worldwide have made a major change in how they support healthcare professionals’ education and training. Read More