• 2020-11-26 10:19:14

Japan has introduced a set of changes, aiming to market innovative products as fast as possible to help patients in Japan with deadly diseases. One of the changes implemented is Fast-Track Approval Scheme.

• 2020-10-29 05:46:11

Qualtech has started providing regulatory services for medical device manufacturers who aim for the Japanese market. Taking this opportunity, we would like to provide a brief introduction of what Japanese regulation requires for foreign manufacturers to sell their products in its market.

• 2020-06-16 08:03:29

PMDA has announced of organizational restructuring of Office of International Programs, aiming strengthening of cooperative relationship with Asian countries.

• 2020-06-16 07:59:23

Amid COVID-19, Japan's Ministry of Health, Labor and Welfare temporarily allows single-use parts of air ventilator to be reused under certain condition.

• 2020-05-12 08:06:46

In order to tackle the threat of COVID-19, PMDA takes some measures to speed up the development of medical products for COVID-19. Now, timeline for clinical trials are shortened and IRB meeting are allowed to be held in unconventional ways.

• 2020-05-06 09:41:29

The OMETA Seminar is back in 2019, to give those interested the tools to evolve and accelerate their business.

• 2020-02-12 13:57:05

Obtaining market access in the Japanese medical device market may sometimes represent a bit of a challenge for foreign manufacturers, we can provide interested customers with the full spectrum of services required for a smooth access to the Japanese market.

• 2020-02-12 13:54:20

On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application.

• 2020-02-12 14:14:35

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.

• 2020-02-14 07:53:58

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