A list of recently published and updated articles regarding medical device regulatory and commercial updates related to the USA.

Medical Device Advertising Requirements in Asia

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.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

TROUBLESHOOTING U.S. HOSPITAL SALES RESULTS

Medical device manufacturers looking to establish or improve sales in the US market should contact our team for market insight and strategy development.

U.S. Medical Device Industry – Open for Business

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.