INDONESIA: RECLASSIFICATION OF FILTER PAPER AS A MEDICAL DEVICE – February/March 2025

• 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

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AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

• 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

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