In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
A list of recently published and updated articles regarding medical device regulatory and commercial updates related to the USA.
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
Medical device manufacturers looking to establish or improve sales in the US market should contact our team for market insight and strategy development.
Uncertainty. If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on.