Case Study
Accredited certification assures the safety of medical devices
ASEAN member countries have agreed to establish the ASEAN Economic Community (AEC) to create a flow of goods and services flow freely in the ASEAN region with the expectation of improving the economy of the member countries of the sector ASEAN. One of ASEAN integration sector priorities is medical equipment, which in the context of ASEAN’s AEC will be arranged in the Medical Devices Directive (AMDD). The medical equipment sector has an important role in the diagnosis, prevention, monitoring, and treatment of disease and in improving quality of life.
The AMDD requires ASEAN countries to implement standardized medical device classification criteria and device placement systems, and to establish post-marketing surveillance alert systems. The Medical Device Product Working Group (MDPWG), which is one of 11 bodies of the ASEAN Consultative Committee for Standards and Quality (ACCSQ), developed the draft AMDD.
Conformity assessment will be a key part of this programme, involving global standards, such as ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, certification and accreditation.
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The ISP, the Public Health Institute in Chile, relies on product certification bodies to ensure the reliability of medical devices. (Chile)
