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Korea - Amendment of "Regulation on standard specification of medical devices"

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Korea - Amendment of "Regulation on standard specification of medical devices"

Harmonize standard specification of medical device with ISO (International Organization for Standardization) international standard - Standard specification of blood glucose monitoring system for self-testing is harmonized with ISO 15197 published in 2013

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.

 


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