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Recently, the Ministry of Health of Indonesia announced that Kertas Saring, also known as Dried Blood Spot (DBS), will be recognized as a medical device effective 9 December 2024. Following the U.S. FDA Classification (CFR Title 21), Dried Blood Spot paper is categorized as a medical device, highlighting its critical role in diagnostic and screening applications. This regulatory update underscores the importance of compliance for DBS used in newborn screening and demonstrated that Indonesia’s regulatory framework is progressing to uphold safety, quality, and efficacy standards.
What is Dried Blood Spot (DBS)?
A specialized medium used to collect, dry, store, and transport whole blood samples and facilitate newborn screening to detect potential health issues early in life.
Regulatory Update for DBS Products in Indonesia
Dried Blood Spot (DBS) products must be registered as medical devices with the MOH through the Online Single Submission (OSS) system. Manufacturers and distributors previously registering DBS as accessories or non-medical devices must now comply with this new classification.
According to the Decree of the Minister of Health No. HK.01.07/MENKES/4745/2021, the classification of medical devices will be as follows:
Product Category: Clinical Chemistry and Toxicology Equipment
Subcategory: Clinical Chemistry Test Systems
Product Type: Blood Specimen Collection Device (Card)
Implications for Stakeholders
All DBS products must meet the updated classification requirements and obtain a medical device distribution permit
Manufacturers must ensure their products adhere to safety, quality, and efficacy standards as outlined in the regulations
These regulatory changes signify Indonesia’s commitment to strengthening healthcare standards, particularly in critical areas like newborn screening. Stakeholders, including manufacturers, importers, and distributors, must act promptly to align with these requirements.
For more information, please refer to the Ministry of Health of Indonesia (KEMENKES)
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