February 2021

Thai FDA issues new regulations on medical device classification and registration

Thai FDA issues new regulations on medical device classification and registration

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, groupings of medical devices, registration …

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Worlds largest trading bloc RCEP

The world’s largest trading bloc, RCEP, has been officially launched

The world’s largest trading bloc was officially signed off on Sunday 15 November. The Regional Comprehensive Economic Partnership (RCEP) accounts for 1/3 of the global economy and includes the 10 ASEAN member states plus Australia, New Zealand, China, Japan and South Korea. The RCEP agreement includes tariff reductions or their elimination and standardized customs procedures for a freer movement of products and services …

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Upcoming changes to medical device registration in Thailand

Upcoming changes to medical device registrations in Thailand

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 Devices General Medical Devices. Registrations …

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COVID 19 has forced us to change the norms of going anywhere and everywhere

Contactless Thermometers in Singapore – the medical device regulations you need to know

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 Devices fall under the definition …

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Philippines FDA issues implementation schedule of AO 2018-002

Philippines FDA issues implementation schedule of AO 2018-002

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 of registration for all medical …

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Malaysia destination specialist cardiology treatments

Malaysia is becoming a destination for specialist cardiology treatments

Malaysia is becoming known as a specialist provider for cardiology treatments as it aims to become the preferred destination for medical tourism in ASEAN. There are over 30 advanced heart treatment centers including the National Heart Institute which earlier this year was the first hospital outside of the USA to implant the world’s tiniest pacemaker, the Micra AV developed …

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Vietnam updates registration safety testing list

Vietnam updates list of medical devices for safety testing

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 machines Electric scalpels Infant incubators …

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