More medical devices manufacturers granted entry into the Philippines, ASEAN markets

The ASEAN Medical Devices Directive (AMDD) harmonizes medical device regulations and classifications across ASEAN for easier access of quality medical devices across the entire region. (Photo courtesy of AMDD)

On 4 March 2021, the Philippines deposited its Instrument of Ratification of the Association of Southeast Asian Nations (ASEAN) Agreement on Medical Devices Directive, with the Agreement entering into force for the country on the same date.

The ASEAN Medical Devices Directive (AMDD) aims to take advantage of the region’s increased demand for medical devices, especially from the region’s growing middle class and the elderly. The AMDD also aims to harmonize regulations for medical device manufacturers and distributors, allowing them to gain access to ASEAN’s market of approximately 650 million people. In contrast, the European Union has a population of around 520 million.

In today’s context, the AMDD is an important part of ASEAN’s ongoing fight against the current pandemic, as this allows the easier distribution of medical devices that are needed for the prevention and treatment of COVID-19. The AMDD is also a vital part of ASEAN’s Comprehensive Recovery Framework (ACRF) and the Regional Reserve of Medical Supplies (RRMS), as demand for medical devices needed to fight COVID-19 and similar pandemics in the future have rapidly increased.

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