On December 16, 2024, the Indonesian Ministry of Health (MoH) issued a regulation (FR.03.01/E.V/2672/2024) classifying Dried Blood Spot (DBS) products as medical devices.
This regulation refers to the classification of DBS as a medical device under the U.S. FDA’s CFR 21 and follows Law No. 17 of 2023 on Health, Article 143, which mandates that the supply of pharmaceuticals, medical devices, and home health products (PKRT) must be authorized by the central or local government. Furthermore, based on Minister of Health Regulation No. 62 of 2017, Article 4, Paragraph 1, any medical device, in vitro diagnostic medical device, or PKRT product distributed within Indonesia must obtain a distribution permit, specifically a product approval license.
DBS products are used for collecting, drying, storing, and transporting whole blood samples for newborn screening(NBS). These products must ensure safety, quality, and efficacy.
Starting from December 16, 2024, manufacturers, importers, and distributors of DBS products that were previously registered as accessories or not classified as medical devices must now register their products as medical devices through the MoH using the Online Single Submission (OSS) system. This is in accordance with the Minister of Health Regulation HK.01.07/MENKES/4745/2021 on the classification of medical devices and related products.
The registration requirements are as follows:
- Product Category: Clinical Chemistry and Clinical Toxicology Equipment
- Product Subcategory: Clinical Chemistry Testing Systems
- Product Type: Blood Specimen Collection Devices (Card)
Please refer to the attached document below.
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