COVID 19 has forced us to change the norms of going anywhere and everywhere. Now that temperature screening, mask wearing and social distancing have become a part of life, you might be curious to know more about contactless thermometers or temperature measurement devices and how they are regulated in Singapore. Contactless Temperature Measuring
The Philippines FDA issued Circular no. 2021-002 on Monday 4th January 2021, which contains the implementation scheduleof the Administrative Order No 2018-002: “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” over three (3) phases. Administrative Order (AO) no. 2018-002 section IX stipulates that the requirement
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.
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