January 2021

Malaysia clamps down on covid-19 test kits

Malaysia clamps down on COVID-19 test kits

The Medical Device Authority (MDA) made an announcement on Monday aimed at the general public and distributors: informing the public that the purchase of COVID-19 test kits is prohibited; and to inform distributors that COVID test kits must use the special access route for registration and that they are only for distribution specifically to healthcare facilities as selling …

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Malaysia issues guidance on medical face masks

Malaysia issues guidance on medical face masks

Last week the Medical Device Authority (MDA) in Malaysia released a new guidance document on face masks and respirators for medical use. The guidance covers performance characteristics, labelling and registration requirements. According to the World Health Organisation (WHO), medical face masks are divided into two categories: procedure masks and surgical masks, both of which are used in clinical/health …

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Vietnam issues guidance document on preparing medical device registrations

Vietnam issues guidance document on preparing medical device registrations

Vietnam’s Ministry of Health recently released a guidance document no. 7395/BYT-TB-CT on preparing medical device registrations. The aim of the document is to help applicants better understand and comply with regulations to speed up the appraisal of registration applications and thereby facilitate the circulation of medical equipment on the market. In accordance with the provisions …

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Philippines FDA relaunches verification portal for medical devices

Philippines FDA relaunches verification portal for medical devices

The Philippines Food and Drug Administration (FDA) has resumed access to its online Verification Portal which provides comprehensive lists of FDA Licensed Establishments and Registered Health Products. The portal is open access so that the general public can verify whether a medical device placed in the Filipino market is properly licensed and distributed by an authorized dealer. The portal was …

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