July 13, 2018

The Medical Device which contain Mercury may only be distributed or traded in Indonesia not more than December 31, 2018. In the other word, a marketing authorization license of medical devices containing mercury that has an expiry date later than December 31, 2018 will be automatically not valid after that date and the owner of a marketing authorization license must surrender the marketing authorization back to the Ministry of Health of Indonesia cq. Directorate General of Pharmaceutical and Medical Devices. Thereafter, if Medical Device which contain Mercury is still found in the market, the distributor that owned marketing authorization must do a recall for those products. It is regulated in Law no. 11 in 2017 about the Ratification Minamata Convention on Mercury.

Moreover, if the distributor still keep the product contained mercury in their storage after December 31, 2018, the medical device must be exterminated in the manner specified by the Ministry of Environment of Indonesia or re-export the products. Distributor that do withdrawal and destruction of medical devices must report such activities to the Ministry of Health RI cq. Directorate General of Pharmaceutical and Medical Devices.

Reference:

Revocation of Marketing Authorization for Medical Devices Containing Mercury

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