On November 2nd, Japan’s Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants. To the Criteria for dental implants, new coating treatment, hydroxyapatite, are now added as an acceptable feature of dental implant. This means that dental implants with hydroxyapatite coating no longer require to be consulted with PMDA before submission.

There are no specific actions required for already approved product.
 


References:

https://www.std.pmda.go.jp/stdDB/Data/RefStd/Std_etc/R041102_1102-10_01.pdf

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