Medical device manufacturers and regulatory consultants operating in Indonesia should be aware of a significant update regarding the classification of Filter Paper, which is previously registered as accessories or non-MDs. According to the official notification FR.03.01/E.V/2672/2024, issued on December 9, 2024 by Indonesia’s Ministry of Health, Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, has been reclassified as a medical device. This reclassification carries important implications for product registration, compliance, and market access within Indonesia. The primary goal of this article is to ensure that our faithful readers are well-informed about this change and its resulting requirements.

Details on Filter Paper (Dried Blood Spot) What kind of product is affected?

Filter Paper, particularly Dried Blood Spot (DBS) Filter Paper, plays a vital role in healthcare, especially in Newborn Screening (NBS) programs. It serves as a medium for collecting, drying, storing, and sending whole blood samples to laboratories. Thus, it is crucial to ensure the safety, quality, and benefits of Filter Paper used in NBS.

Regulatory Basis for the Change: Aligning with US FDA regulatory standard

The decision to reclassify Filter Paper as a medical device (MD) is supported by several key pieces of legislation and regulatory standards:

• Law No. 17 of 2023: Article 143 mandates that pharmaceuticals, MDs, and household health supplies (PKRT) require business permits from the central or regional government.
• Regulation of the Minister of Health No. 62 of 2017: Article 4, Paragraph 1, states that MDs, In Vitro Diagnostic MDs, and PKRT that are produced, imported, assembled, and/or repackaged for distribution in Indonesia must have a distribution permit.
• Code of Federal Regulations (CFR) Title 21 U.S. FDA: While not an Indonesian regulation, it's noteworthy that the U.S. Food and Drug Administration (FDA) categorizes Dried Blood Spot Filter Paper as a MD. This international precedent provides additional context for Indonesia's decision, aligning its regulatory stance to a major international regulatory body.

Practical guide: New Classification Details

Prior to this notification, some manufacturers might have registered Filter Paper as accessories or non-MDs. However, as of December 9, 2024, Filter Paper must now be registered as an MD through the Online Single Submission (OSS) system. This classification aligns with the Decree of the Minister of Health Number HK.01.07/MENKES/4745/2021 regarding the Types and Nomenclature of MDs.

The specific classification is as follows:

• Product Category: Clinical Chemistry and Clinical Toxicology Equipment
• Product Subcategory: Clinical Chemistry Test System
• Product Type: Blood Specimen Collection Device (card)
• Risk Class in Indonesia: Class B

Implications for Manufacturers and Regulatory Consultants

This reclassification update has several practical implications for manufacturers of Filter Paper in MDs:

• New Registration Requirements: Manufacturers who produce or import Filter Paper must initiate the process of registering their products as MDs via the OSS system. This involves preparing the necessary documentation, meeting quality standards, and undergoing evaluation by relevant authorities.
• Compliance with Quality Standards: Filter Paper products must comply with the quality standards set forth for MDs. This may involve implementing Quality Management Systems, conducting product testing, and complying to Good Manufacturing Practices.

 

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References:

• Official Notification by Indonesia’s Ministry of Health (FR.03.01/E.V/2672/2024)
• Republic of Indonesia Law No. 17 of 2023 about Health  
• Regulation of the Minister of Health No. 62 of 2017
• Code of Federal Regulations (CFR) Title 21 U.S. FDA
• Decree of the Minister of Health (HK.01.07/MENKES/4745/2021)