The Vietnamese Ministry of Health (MOH) released Circular 33/2020/TT-BYT on 31st December 2020 which regulated for updating the list of medical devices that require safety testing and technical inspection. The list of medical devices that must undergo safety testing and technical inspection has been updated to include the following: Breathing machines Anaesthetic breathing
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
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
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.
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
We’re happy to share that Indonesia’s National Public Procurement Agency (NPPA = LKPP) has again opened its e-Catalogue to imported medical devices. This means that both imported and domestic Medical Devices and Health Service Support Equipment (Non-Medical Devices) can be submitted. The e-Catalogue was last opened to imported medical devices in
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