HSA has finalized the Guidelines for Telehealth Products. Telehealth products refer to "instruments, apparatus, machines or software involved in the provision of healthcare services over physically separate environments via information communication technologies."
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Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on Conformity Assessment for Medical Device that are yet to be registered.
More Malaysia’s healthcare system consists of two tiers: a state-owned universal healthcare system for national citizens runs alongside a private sector that serves international patients. Due to projected demographic shifts – chiefly Malaysia’s ageing population, increasing life expectancy and the growth of non-communicable diseases – demand for medical device is expected to grow.
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Indonesia Hospital Association will hold the 30th Indonesian Hospital Expo on October 18-21st 2017 in JCC Senayan, Jakarta. This is the biggest medical device exhibition in Indonesia which is participated in by both foreign and local companies to exhibit their products. The number of exhibitors and visitors are increasing every year,
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Starting in 2017, all medical devices imported into Vietnam will be required to register for Marketing Authorization (MA) licenses. The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and began receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D.
More On October 8, the General Office of the CPC Central Committee and the General Office of the State Council issued "the Reformed Examination and Approval System of CFDA to Promote Drug and Medical Device Development and Innovation", and required all localities and departments to implement.
More 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.
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