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ProjTitle.icon Purpose

​The purpose of this document is to clarify the significant and non-significant changes; referred to article (10/8) of Executive Regulation of Law of Medical Devices, and section (5) of “Requirements for Medical Devices Marketing Authorization (MDS-REQ1)” indicating that SFDA shall be informed, via the electronic system, within (10) days of the occurrence any significant change to the relevant information or (30) non-significant change.​

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