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.
Please ensure that the cleanroom/controlled environment has been properly validated and that adequate ongoing monitoring of the operating environment be sustained.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.