In Brief: Online IVD Registration Pathway Announced for Malaysian Market

Malaysian medical device regulators now offer online registration for in vitro diagnostic (IVD) device manufacturers.

The Malaysian Medical Device Authority has built in support for IVD registrations to its Medical Device Centralised Application System (MEDCAST) online application system, as well as issued new guidelines on a 12-step registration process for IVDs.

Applications for IVD registrants in Malaysia should include general manufacturer information, device technical and grouping data, post-market vigilance history in other markets, and validation data including Common Submission Dossier Templates (CSDT).

Stewart Eisenhart

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