A list of recently published and updated articles regarding medical device regulatory updates from the PMDA and other governing bodies in Japan.

Innovative Medical Device Registration 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

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).

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.

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.

Asia Actual is the Best Medical Device Consulting Company in Asia

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 Shipments During the COVID-19 Pandemic

COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

4 Product Development Decisions that Impact Sales Performance in Asia

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.

Know Your Market Price in Japan

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.