PFDA issued FDA Circular No. 2022-003 that bans the production and all kinds of market exchanges, such as distribution, sale, and advertisement, for several mercury-added devices and related products for safety reasons.
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Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.
More 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.
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