To provide a platform for cooperation on medical products regulation issues of mutual interest and to enhance mutual understanding with confidence, The Interchange Association and The Association of East Asian Relations concluded the arrangement for the establishment of the framework of the cooperation on the medical products regulation in 2013.
Based on this arrangement, PMDA makes presentations at symposia and publishes position papers and Q&A documents confirmed by both sides in cooperation with Taiwan Food and Drug Administration (TFDA) to enhance regulatory harmonization between Japan and Taiwan.
Symposia
The Taiwan-Japan Symposium is conducted to tighten the mutual relationship and the cooperative framework for regulation of medical products and to promote thorough understanding of regulatory systems in Japan and Taiwan. The latest three symposia are shown here.
12th
Date: October 7, 2024
Location: Tokyo, Japan
Number of participants: 178
Program and Materials
11th
Date: October 5, 2023
Location: Taipei, Taiwan / Online
Number of participants (Approx.): 160 (In-person) / 500 (Online)
Program and Materials
10th
Date: October 20, 2022
Location: Tokyo, Japan / Online
Number of participants: 77 (in-person) / 500 (Online)
Program and Materials
Position Paper / Q&A
PMDA publishes position papers and Q&A documents regarding medical products regulation in Japan and Taiwan.
(Please refer to the latest regulations as Q&A shown here might become no longer applicable due to regulatory changes.)
New Drug Review Scheme
Japan and Taiwan are operating the new drug review scheme to conduct new drug review effectively by using review report. The position paper and Q&A are published.
Position Paper on New Drug Review Cooperation between Japan and Taiwan (Oct 2019) [142 KB]
Q&A for the New Drug Review Scheme (Revised on Nov 2023) [151KB]
Product Registration Process for Medical Device in Taiwan and Japan
Position paper and Q&A on product registration process (approval) are published to promote better understanding on product registration process for medical device between Japan and Taiwan.
Position Paper for better understanding on product registration framework for Medical Device between Japan and Taiwan (Oct 2021) [334 KB]
Question & Answer for Product Registration Process for Medical Device in Taiwan and Japan (Revised on Oct 2024) [199KB]
QMS MOC Framework for Medical Device
Based on the “Memorandum of Cooperation between the Japan-Taiwan Exchange Association and the Taiwan-Japan Relations Association on the Field of Medical Device Quality Management System Requirements” concluded in 2018, “Position Paper on Q&A for the QMS MOC framework for Medical Device in Taiwan and Japan” are published to promote efficient use of the medical device QMS audit reports and QMS compliance certifications.
Position Paper on Question and Answer for the QMS MOC framework for Medical Device between Japan and Taiwan (Oct 2020) [68.4KB]