• 2025-11-21 07:03:32

PMDA updated the document requirements for QMS conformity inspections on October 1, 2025. The following is a summary of the revisions to the submission requirements for the QMS Conformity Inspection documents, comparing the version dated January 18, 2024 with the version dated October 1, 2025.

• 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.

• 2025-09-24 07:40:52

PMDA has revised the approach to biological safety evaluation and abolished the previous notification issued on Jan 6, 2020. The revised approach focuses on providing practical instructions for preparing regulatory submissions.

• 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.

• 2025-02-21 05:20:11

Japan's contact lens market is growing rapidly, driven by high myopia rates, aesthetic preferences, and strong domestic demand. A robust network of 2,340+ ophthalmology departments and qualified eye care professionals support the growth of the contact lens market in Japan. Daily disposables dominate this market, supported by a well-established ophthalmology infrastructure. Qualtech offers valuable insights of the Japanese contact lens market in this article, revealing a promising opportunity for foreign manufacturers.

• 2024-11-05 02:28:52

Japan is grappling with a growing cancer crisis, which has become the leading cause of death and is expected to increase significantly in the coming decades due to an aging population. To address this, Japan has strengthened its healthcare system by designating hundreds of hospitals as cancer care centers. The rising healthcare burden creates opportunities for innovative medical technologies to improve cancer diagnosis and treatment. With a strong focus on technological advancement and openness to foreign innovation, Japan presents a promising market for medical device manufacturers, where expert regulatory guidance is essential for success.

• 2024-09-17 06:26:38

Japan's thriving healthcare market, driven by innovation and growth in medical technology, offers unparalleled opportunities for medical device manufacturers. Qualtech Consulting provides expert regulatory and clinical evaluation services to help you navigate this complex landscape and successfully enter the East Asian market.

• 2024-07-30 07:16:31

Japan's diagnostic imaging market is projected to grow at a CAGR of 6.28% from 2022 to 2027, becoming a major segment within the country's medical devices sector. The oncology segment is expected to lead this growth due to rising cancer incidences and technological advancements in diagnostic imaging, including AI and data automation, enhancing diagnostic and treatment processes.