CDSCO clarification on License for medical device manufacturers

The Central Drug Standard Control Organization vide notice dated 11 July, 2022 has clarified that quality certificates issued by private entities shall not be a replacement of license to be granted under Medical Devises Rules, 2017 by competent licensing authority.

Therefore all manufacturers of medical devices shall obtain a license granted under Medical Devises Rules, 2017 by competent licensing authority.

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