On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application.
More Japan Association of Medical Device Industry (JAMDI), DEKRA Japan, and Qualtech Japan will jointly held an upcoming seminar on 21st December, 2018 at Dawn Center Osaka, Japan.
More edtec Japan, Asia’s largest tradeshow dedicated to the design and manufacturing of medical devices will take place from 18 to 20 in April 2018 at Tokyo Big Sight. Qualtech, as a professional medical device regulatory consulting firm in Asia, will participate the event this year to provide regulatory solution for all medical devices to meet the requirement in Asia countries
More Last August 1, 2017, in line with Qualtech bringing its services closer to clients, a business office was opened in Japan. The new office offers medical device regulatory research and consultancy for product registraiton, local representation and clinical trial services in China, Taiwan and ASEAN to our Japanese clients
More 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.
In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.
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.
In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.
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