• 2022-11-29 02:56:30

Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.

• 2022-07-26 11:17:42

To make sure vigilance is compiled among related stakeholders, MHLW announced important reminders on hazard prevention measures based on research and surveys conducted.

• 2022-07-26 11:13:22

MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.

• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2022-04-27 10:59:13

On March 25th, 2022, Qualtech held an online seminar to introduce Japanese health authorities' requirements on technical data, which can be submitted during PMDA/RCB's approval process.

• 2022-04-27 11:22:13

On March 4th, 2022, the Japanese Ministry of Health, Labor and Welfare issued a summary of the Q&A related to the New QMS Ordinance. This notice clears frequent questions and gives related manufacturers/manufacturing authorization holders a more detailed idea on how to be prepared for the new QMS regulation.

• 2022-01-26 10:34:06

Previously Japan's PMDA has been accepting MDSAP reports to substitute PMDA's Quality Management System Inspection. However, this move will become official starting April 1st, 2022.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-10-27 07:52:46

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

• 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.