• 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.

• 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.

• 2023-09-27 07:52:28

Qualtech's webinar on medical device registration in Japan highlighted the critical aspect of reliability inspection. Key topics covered include the registration process, PMDA's role, and the requirements of the reliability inspection. The webinar provided valuable insights into this complex process, facilitated by expert speakers from Qualtech.

• 2023-09-27 07:05:52

The Japanese MHLW has issued Q&A on Software Cybersecurity that was newly added to the Essential Principle

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-05-24 07:21:35

The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.

• 2023-04-25 01:46:23

The Japanese Industrial Standard of EMC (JIS T0601-1-2) has been amended.