This document is intended to guide the submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate modules in MEDICS for uploading the corresponding CSDT or IMDRF ToC dossier sections.
Background :
Product registration applications for medical devices are submitted online to HSA. They may be compiled and prepared from the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Medical Device Market Authorisation Table of Contents (nIVD MA ToC) from the medical device manufacturer. Applications must be submitted online to HSA via MEDICS. The technical dossier and supporting documents shall be submitted in softcopy in MEDICS.
Submissions based on CSDT Please refer to the “CSDT TR-01” column of TABLE 1 to determine which sections of the CSDT are to be uploaded under each module in MEDICS.
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