By Stewart Eisenhart, Emergo Group India’s medical device registration system is still transitioning to a more formalized and predictable framework, which has raised questions from foreign manufacturers about what regulators do and do not currently require for market authorization in the country. In many cases, one requirement foreign firms can be sure of is the […]
Emergo Group
FDA delays final guidance plans for laboratory developed tests
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have put on hold plans to publish final guidance regarding laboratory developed tests (LDTs) in order to develop a more appropriate oversight approach, according to the agency. The opinions expressed in this blog post are the author’s only and do […]
Medical device industry laws in the wake of “Hard Brexit”
By Ronald Boumans, Emergo Group In 2016, we discussed the possible options for what a Brexit could look like and what the British prime minister meant with “Brexit means Brexit.” The official date of announcing formally that the United Kingdom wants to leave the European Union is fast approaching. Get the full story here at […]
South Korean medical device regulatory changes updates
By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]