• 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.

• 2022-12-27 07:25:52

On October 17th, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Japanese Standard for Sterilization Validation.

• 2022-12-27 07:16:43

On November 2nd, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants.

• 2022-11-29 03:32:40

Qualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.

• 2022-11-29 03:04:45

As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.