The Philippines FDA has set new performance requirements for the various types of COVID-19 test kits available on the market in the Philippines with immediate effect. The PFDA issued Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” on 23rd March 2021 which applies
The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021 and the remainder comes into effect on 17th March 2021. The new regulations include changes in product classification for both IVD and non-IVD medical devices, types and stages of submission,
All medical devices to enter Thailand, whether manufactured domestically or imported, are regulated by the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Currently, the registration of medical devices is classified according to the level of control, which lists 3 levels: Licensed Medical Devices Notified Medical
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
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