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JAPAN:  Q&A for Complying with the New QMS Ordinance -Part 4 – April, 2022

JAPAN: Q&A for Complying with the New QMS Ordinance -Part 4 – April, 2022

  • 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.

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Evaluation Principles of Medical Devices for Home Medical Care in Japan

Evaluation Principles of Medical Devices for Home Medical Care in Japan

  • 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.

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QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

  • 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.

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QT Webinar: Japan Medical Device Registration

QT Webinar: Japan Medical Device Registration

  • 2021-09-06 06:11:51

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "Japan Medical Device Registration". Our event is scheduled to be held on September 17th (Friday), 2021.

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QT Analysis: Registration of Quality Management System in Taiwan & Japan  - August 2021

QT Analysis: Registration of Quality Management System in Taiwan & Japan - August 2021

  • 2021-08-26 13:03:08

One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.

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