he conference began with Qualtech's Global Manager Irene Lu explaining the regulation changes in ASEAN countries and shared Qualtech's registration experiences in the local countries. Then, MedNet CEO, Mr. David Thaler, shared the responsibilities and obligations of EU representatives under the implementation of the new MDR.
More Industry Facts: 27-28 November 2017Philippines positioning itself as a leader in healthcare outsource services.
Hong Kong Trade Development Council: The Philippines: Market Profile
The Government of India notified in February 2017 the new Medical Device Rules 2017, which will come into force starting January 1, 2018. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.
More We are pleasure to share the successful seminar which had been held on July 10th by Japan Analytical Instruments Manufacturers' Association(JAIMA),
More With a solid business foundation dating back to 1968, TÜV SÜD Japan was established in 1993 to meet the increasing demand for enhanced quality and safety testing and certification in the Japanese market.
More More and more regulatory had been set up and released in ASEAN countries recently.
More Association of Southeast Asian Nations (ASEAN) is composed of 10 countries in Southeast Asia. It’s the market with good potential for someone who would like to build a stance in the market of medical devices.
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”.
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