Asean Agreement On Medical Device Directive (Amdd)

The ASEAN Medical Device Committee (AMDC) was established in 2014 to coordinate the implementation of the ASEAN Medical Devices Directive (AMDD), an agreement between the ten ASEAN member states on harmonising the regulatory framework for medical devices. The main objective is to facilitate trade and market access for medical devices in ASEAN by removing technical barriers. For more information on regulatory requirements and the registration process for medical devices and medicines in Malaysia, see the registration of medical devices in Malaysia and the registration of drugs and API products in Asia. In 2012 and 2013, Emergo and other medical device information sources have already reported on the efforts of the Association of South Asian Nations (ASEAN) trade bloc to establish harmonized device registration systems in 10 countries in the region. The Philippine Food and Drug Administration (FDA) works under the supervision of the Ministry of Health and is responsible for monitoring and regulating medicines 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) are bringing in drugs or medical devices. Malaysia ratified ASEAN AMDD at the end of 2017. The MDA confirmed that stakeholders have complied with the obligation to register medical devices. In its letter of May 2, 2018, all devices must be registered or deposited by June 30, 2018. New labelling requirements are underway and implemented until Q3 2018. Halal certification is also under development and is now in the final phase of the consultation.

Jakim will launch Halal certification until Q3 2018. The draft guidelines are available as a reference, but the official guide is expected to be linked in the third quarter of 2018. Unlike Indonesia, halal certification in Malaysia is not mandatory, but only when companies consider it necessary. Not fully implemented. The recent important legislation, The Medicines and Medical Devices Act No. 07/NA, issued in 2012, is in accordance with the AMDD.

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