• 2026-08-25 04:02:15

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

• 2026-04-23 08:41:55

Japan's orthopedic medical device market is drawing increasing global attention, supported by strong import activity and rising clinical demand. In 2023, orthopedic equipment accounted for the largest share of Japan's medical device imports at 14.9%, while orthopedic appliances alone reached US$2.67B in imports in 2024. With nearly 30% of the population aged 65 and above and more than 3.4M orthopedic procedures performed annually, Japan continues to see growing demand for advanced musculoskeletal solutions.

• 2026-02-25 03:48:52

PMDA recently released the revision for managing changes to raw materials used in medical devices. The revision clarifies the scope of minor change notifications that do not impact safety or performance and consolidates the criteria for determining applicability in low-risk cases or where sufficient prior usage experience exists.

• 2026-01-30 04:39:59

Recently, in the tempu bunsho (Japanese approved IFU) of pharmaceuticals containing hydroxycarbamide as the active ingredient, a warning was issued that, when taking this drug, glucose measurement results may show values higher than the actual glucose level (false high values).
Accordingly, similar warnings should also be included in the tempu bunsho of blood glucose measuring devices. Therefore, for blood glucose measuring devices using the enzyme electrode method, a voluntary review of the tempu bunsho should be conducted, and, if necessary, revisions and dissemination of information to should be implemented.

• 2025-10-27 02:31:38

PMDA released a notification for the medical industry to reference the "Practical Guide for Radio Wave Management of Medical Telemetry Devices", prepared and released by the Electromagnetic Compatibility Conference Japan (EMCC). The purpose of the guide is to provide operational guidelines for radio management of medical telemeter systems (wireless physiological monitoring devices used in hospitals and healthcare facilities), ensuring interference prevention, safety, and proper use. In addition, the guide is intended to promote the development and utilization of practical manuals tailored to individual user groups, such as nurses, clinical engineers, and hospital administrators or administrative staffs.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-08-15 01:48:59

On September 4th, join Qualtech for an insightful webinar, "Entering Japan and South Korea: Understanding PMDA and MFDS Requirements for Medical Devices". This session will offer practical guidance on navigating the regulatory systems of Japan and South Korea – ideal for companies seeking to accelerate market entry and avoid compliance-related issues.

• 2025-07-10 09:45:06

The Japanese Ministry of Health, Labour and Welfare is enforcing the implementation of the new JIS standard for Electromagnetic Compatibility (EMI/EMC) (JIS T 0601-1-2:2023) as of February 25, 2026.

• 2024-07-30 06:35:03

The demand for Remote Patient Monitoring (RPM) devices in Japan is surging, driven by technological advancements, an aging population, and a shift towards home-based care. The market, valued at $2.06 billion in 2024, is projected to reach $2.93 billion by 2029, growing at a CAGR of 7.26%. Key segments include cardiac and neurological monitoring devices. Government initiatives and the shift towards home-based care further support this growth, offering significant opportunities for medical device manufacturers.

• 2023-10-20 06:59:35

PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.