Medical equipment (ICS code(s): 11.040)

Draft FDA Circular entitled "Abridged Processing of Application for Registration/Notification of Medical Devices Approved by National Regulatory Authority of Any ASEAN Member Country"; (4 page(s), in English)

The Circular aims to carry out good reliance practices in the regulatory processes of medical devices. Specifically, it intends to provide guidelines on the abridged processing of application for registration of medical devices with product approval issued by the National Regulatory Authority of any ASEAN member country under the ASEAN Medical Device Directive- Common Submission Dossier Template requirements.