A list of recently published and updated articles regarding medical device regulatory updates from the PMDA and other governing bodies in Japan.
In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
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.
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.”
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
Japan should be the second largest national market for your medical device after the United States and maximizing sales performance in Japan should be critical to your overall corporate success. Yet, many manufacturers are frustrated by their results in Japan or struggle to attract the interest of leading distributors. Follow these steps to create a winning market strategy in Japan that will wow investors and leapfrog the competition.
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