① Pre-market approval/ certification and classification of medical device under Pharmaceutical and Medical Device Act in Japan
② Medical Device regulatory requirements and current status in the ASEAN region

On February 9, 2024, we held the 6th Academia Clinical Development Seminar online, inviting Dr. Kazuya Hijii from mk DUO LLC, an expert on domestic and international laws and regulations related to medical devices, to speak on “(1) Pre-market approval/ certification and classification of medical device under Pharmaceutical and Medical Device Act in Japan, (2) Medical Device regulatory requirements and current status in the ASEAN region”.

First of all, he explained the medical device regulations in Japan.
In Japan, he said, in order to ensure the efficacy and safety of medical devices, the industry is divided into manufacturing, marketing, distributing, lending, and repair businesses, and the possession of business licenses for each is a regulatory requirement unique to Japan.
In particular, he said that in order to obtain a marketing license with full responsibility for the market, the marketing holder must meet requirements related to personnel, Quality Management System (QMS), and Good Vigilance Practice (GVP) and must work with each business license holder to continue to demonstrate the quality, efficacy, and safety of medical devices.

Also, for product licenses, he said, each developed product must receive pre-market approval/ certification for market distribution according to its classification.

Second of all, he explained the medical device regulatory requirements in the ASEAN region.
He said that in ASEAN, the ASEAN Medical Device Directive (AMDD), an important guideline for the regulation of medical devices, was agreed upon among 10 countries in 2014.

The AMDD aims to harmonize medical device-related laws and regulations and standardize technical documentation, and a system has been established for mutual certification/ approval of applications for medical device summaries, quality management systems, technical documentation, and post-marketing requirements using a form called the CSDT（Common Submission Dossier Template）, he said.
He also said that in comparing medical device regulations between Japan and ASEAN, there is no significant difference in requirements, but when developing in both regions, the key process to speeding up is to take ASEAN requirements into account while preparing technical documentation.

In this seminar, he gave us an informative lecture on medical device regulations, and the seminar ended successfully with a lively question and answer session.

We will continue to cover topics that will help researchers and invite leading lecturers in those fields. We look forward to your participation.