Choosing the right CRO has a big impact on product registration and time to market.
Technology that quickly and accurately diagnoses cancer will be in high demand in the coming years.
Achieving success in India involves patience and a firm grasp on the culture and regulatory environment.
As the incidence of diabetes across Asia expands, demand for medical devices and drugs to treat the disease is intensifying.
After preparing for three key issues, follow these recommended strategies when pursuing the market in Japan.
Japan is one of the largest medical device markets in the world, and there are several reasons you should consider pursuing it.
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
Reform of the Japanese mixed medical treatment system should lead to increased opportunities for Western medical companies in Asia’s largest healthcare market.
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.