• 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.

• 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.