Asean Agreement On Medical Device Directive

Asean Agreement On Medical Device Directive

A recent meeting of Southeast Asian economic ministers in Myanmar resulted in the formal signing of an agreement between ten countries establishing a harmonized framework for the registration of medical devices. Malaysia ratified ASEAN-AMDD at the end of 2017. MDA confirmed stakeholders` compliance with the mandatory registration of medical devices. In their letter of May 2, 2018, all devices must be registered or requests submitted before June 30, 2018. New labelling requirements are being developed and are expected to be implemented by the third quarter of 2018. Halal certification is also under development and is now in the final phase of consulting. Jakim will implement halal certification until Q3 2018. The draft guidance is available as a reference, but the official guide is expected to cover the third quarter of 2018. Unlike Indonesia, halal certification is not mandatory in Malaysia, but only if companies deem it necessary. Not fully implemented, but many elements already exist. Halal certified. Currently, HALAL certification is carried out on a voluntary basis by MUI.

When implementing the halal law, certification is mandatory and must be issued by BPJPH. The regulation of products under this law will be done in stages, with the medical devices concerned falling into years 1 to 5 (from the passage), estimated between October 2019 and 2024. At present, it is not clear when the law will be implemented, as is the impact it will have on registration fees and delays. The Philippine Food and Drug Administration (FDA) works as a department under the supervision of the Ministry of Health and is tasked with monitoring and regulating drugs and medical devices. Within the FDA, the Center for Drug Regulation and Research (CDRR) and the Center for Device Regulation, Radiation Health and Research (CDRRHR) oversee drugs or medical devices. Not fully implemented. The last major legislation, the Medicines and Medical Devices Act No. 07/NA, published in 2012, corresponds to AMDD. Under this law, companies that register their medical devices in Laos will comply with the ASEAN classification of medical devices and follow the CSDT format in the application. I hope that it will not be long before all Member States fully comply with the AMDD and medical devices can be registered or reported by electronic systems, as Singapore, Malaysia and Indonesia are doing. This achievement will certainly bring direct and indirect economic and other benefits to the medical device and health industry and the region as a whole.

In 2016, ASEAN members will focus on developing a work plan for the implementation of the AMDD, with the Singapore Health Authority leading the initiative. The scope of the work plan will include the development of a common nomenclature, guidelines for post-market surveillance and guidelines for the grouping of equipment. Singaporean regulators have already put in place AMDD-compliant processes to address these issues. In 2015, the Association of Southeast Asian Nations (ASEAN) signed an agreement officially called the ASEAN Medical Device Directive (AMDD) to harmonize rules for medical devices. AMDD offers medical device manufacturers an easier path to market….


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