The Indonesian Ministry of Health (MoH) has officially announced, under number FR.03.01/E.V/2672/2024, that Dried Blood Spot (DBS) is now classified as an In Vitro Diagnostic (IVD) medical device. This classification aligns with regulation PMK 62/2017 and references the Code of Federal Regulations (CFR) Title 21 from the U.S. Food and Drug Administration (FDA).

Dried Blood Spot is a method used to collect, dry, store, and transport whole blood samples to laboratories for newborn screening (NBS). This technique is crucial for the early detection of various health conditions in newborns, significantly contributing to improved healthcare outcomes.

For information regarding new registrations, changes, and extensions of your medical device and IVD device, please contact us.

Source : Letter from the Ministry of Health of the Republic of Indonesia regarding Notification of Filter Paper products as Medical Devices