Apr 1, 2019
EMERGO BY UL SUMMARY OF KEY POINTS:
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.
The new fees have taken effect as of April 1, 2019 (link in Japanese). PMDA has issued three related documents to provide additional details regarding these increases:
Japanese regulators have provided a schedule for how new medical device registration fee structures affect existing market applicants.
Applications received by PMDA by March 29, 2019 qualified for the agency’s previous fee structure; applications received on or after April 1 will be subject to the new fees, according to PMDA.
EMERGO SUMMARY OF KEY POINTS:
Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how some of the new ISO 13485:2016 quality system standard for medical devices will be incorporated into the country’s own QMS requirements.