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Hi All,
It seems like MFDS is re-categorizing the class 1 medical device by its usage. We had several instruments that were originally registered under "manually operated instrument" certificate being removed, and has to re-register them under a different category (e.g. reamers has to go under reamer permit, etc.). Is anyone in a similar situation too? Can we still sell the instruments while it's being re-registered?
Does anyone has any insight on when this regulation was revised, and if possible, send me the notification number that is relevant to this? Does it falls under Medical Device Act, Enforcement Decree of Enforcement rules (ordinance of the Prime Minister), or MFDS notification?
Thanks!