On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product.
Below is a detailed summary of the notification and its key requirements:
Below is a detailed summary of the notification and its key requirements:
Details of the Product and Its Classification
Product Overview:
Dried Blood Spot is a product used to collect, dry, store, and transport whole blood samples to laboratories, primarily for Newborn Screening (NBS). Ensuring its safety, quality, and efficacy is critical for public health.
Updated Classification:
Effective immediately, Dried Blood Spot products that were previously registered as accessories or not classified as medical devices must now be formally registered as medical devices with the Ministry of Health. The specific classification is as follows:- Category: Clinical Chemistry and Clinical Toxicology Devices
- Subcategory: Clinical Chemistry Test Systems
- Product Type: Blood Specimen Collection Device (card)
Background and Regulatory Basis
- Relevant Legislation:
- Law No. 17 of 2023: Article 143 mandates that Pharmaceutical Preparations, Medical Devices, and Household Health Products (PKRT) must obtain business licenses from the Central or Regional Government.
- Minister of Health Regulation No. 62 of 2017: Article 4, paragraph 1 specifies that Medical Devices, In Vitro Diagnostic Devices, and PKRT produced, imported, assembled, or repackaged for distribution in Indonesia must have a Product Approval License.
- Global Classification Reference:
- As per the Code of Federal Regulations (CFR) Title 21 by the U.S. FDA, Dried Blood Spot is classified as a medical device.
Registration Requirements
- Submission Platform:
Registration must be completed via the Online Single Submission (OSS) system as per the Decree of the Minister of Health No. HK.01.07/MENKES/4745/2021, which outlines the types and naming of medical devices. - Effective Date:
The requirement is effective immediately from the date of this notification, which is December 16, 2024.
For additional details, you can access the official notification document:
Surat Pengumuman Kertas Saring Sebagai Alat Kesehatan_Kemenkes.pdf (in Indonesian, no English translation available).
Should you have any questions or need assistance, please reach out to us at sales@andamanmed.com or click the button below.
Surat Pengumuman Kertas Saring Sebagai Alat Kesehatan_Kemenkes.pdf (in Indonesian, no English translation available).
Should you have any questions or need assistance, please reach out to us at sales@andamanmed.com or click the button below.