Indonesia: Stipulation of Circulation Permit and Circulation of Medical Devices Containing Mercury

2018-10-24T14:36:28+08:00 August 3rd, 2018|News & Events|
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Medical devices containing mercury may only be circulated or traded in Indonesia until December 31, 2018. Marketing authorization licenses for such devices that are valid until after December 31, 2018 will be declared no longer valid after that date.

Based on the law no. 11 of 2017 on the Minamata Convention on Mercury, mercury and its compounds are considered very dangerous to health and the environment because of their toxicity, persistence in the environment, bioaccumulation and ability to travel in the atmosphere. In order to ensure the creation of a clean and healthy environment for the people of Indonesia, and to protect future generations from the negative impact of mercury, the Indonesia Ministry of Health issued circular letter no. HK.02.02/V/0720/2018 regarding the circulation of medical devices containing mercury.

According to the circular, medical devices containing mercury may only be circulated or traded in Indonesia until December 31, 2018. Marketing authorization licenses of such devices that are valid beyond December 31, 2018 will be declared no longer valid after that date (frozen automatically on the online registration system) and the owner of the circulation permit will need to return the marketing authorization to the Ministry of Health cq. Directorate General of Pharmaceutical and Medical Devices. If after December 31, 2018, there are medical devices containing mercury in the market, then the distributor of the medical device will recall the product. If the distributor of medical devices still has product in storage after December 31, 2018, it must destroy the product in accordance with the regulations issued by the Ministry of Environment of Indonesia or re-export. Medical device distributors who withdraw and destroy product must report such activities to the Ministry of Health of the Republic of Indonesia cq. Directorate General of Pharmaceutical and Medical Devices.