On 16 October 2026, Indonesia’s Ministry of Health issued Circular No. FR.03.01/E.V/2204/2026. Its annex lists 16 adjustment records covering hepatitis virus testing, HIV testing, nucleic acid testing for respiratory pathogens, immunohistochemistry reagents, Mycobacterium tuberculosis testing and immunological calibrators. The updates focus on three areas: risk class increases for certain products, further refinement of product types, and the reassignment of immunological calibrators to a different category.
Official source
Original Indonesia Ministry of Health circular (regalkes.kemkes.go.id)
1. Risk Class Increases for Five Product Types
Five records in the annex to the circular involve risk class changes. Qualitative immunohistochemistry reagents move directly from Class A to Class C, while the other four product types move from Class B to Class C:
| Product type | Previous risk class | New risk class | Key change |
|---|---|---|---|
| Multiplex nucleic acid testing for respiratory infections | Class B | Class C | The new product name is multi-target nucleic acid testing of respiratory specimens, covering the detection and identification of SARS-CoV-2, the virus that causes COVID-19, and other microorganisms associated with respiratory infections. |
| Qualitative immunohistochemistry reagents and kits | Class A | Class C | The new name is standardised as Immunohistochemistry reagents and kits. These products are used for immunohistochemical staining of tissue specimens, including tumour tissue, to support histopathological analysis. |
| Quantitative immunohistochemistry reagents and kits | Class B | Class C | These products are likewise grouped under Immunohistochemistry reagents and kits, merging the former qualitative and quantitative categories under a single product name. |
| Nucleic acid testing for the Mycobacterium tuberculosis complex | Class B | Class C | Uses nucleic acid amplification methods such as PCR to detect genetic material from the Mycobacterium tuberculosis complex in respiratory specimens, such as sputum. |
| Detection of Mycobacterium tuberculosis and associated drug-resistance genes | Class B | Class C | Detects genetic mutations associated with resistance to anti-tuberculosis drugs while also detecting the Mycobacterium tuberculosis complex. |
Under the revised classification, qualitative and quantitative immunohistochemistry reagents share the same English product name. Both are uniformly assigned to Class C; the qualitative/quantitative distinction no longer results in different risk classes.
2. New Product Types for HCV, HBV, HIV and Immunological Calibrators
The circular also introduces a number of specific new product types. Previously, these products could only be listed under broader immunological test system types. The update establishes distinct types for serology, nucleic acid testing, viral load monitoring and other intended uses:
| Product category | Previous product type | New product type |
|---|---|---|
| Hepatitis C virus (HCV) serological testing | Antinuclear antibody immunological test system | Hepatitis C virus Serological tests |
| HCV RNA nucleic acid testing for infection monitoring and viral load monitoring | Antinuclear antibody immunological test system | Nucleic acid-based hepatitis C virus ribonucleic acid tests |
| HCV RNA nucleic acid testing for infection diagnosis and/or monitoring | Antinuclear antibody immunological test system | Nucleic acid-based hepatitis C virus ribonucleic acid tests |
| Hepatitis B virus (HBV) serological testing | Antimitochondrial antibody immunological test system | Hepatitis B virus Serological tests |
| HBV nucleic acid testing for infection monitoring and viral load monitoring | Antimitochondrial antibody immunological test system | Nucleic acid-based hepatitis B virus tests |
| HBV nucleic acid testing for infection diagnosis and/or monitoring | Antimitochondrial antibody immunological test system | Nucleic acid-based hepatitis B virus tests |
| HIV viral load monitoring | Multiple autoantibodies immunological test system | Human immunodeficiency virus (HIV) viral load monitoring test |
| HIV serological diagnosis and supplemental testing | Multiple autoantibodies immunological test system | Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test |
| HIV nucleic acid diagnosis and supplemental testing | Multiple autoantibodies immunological test system | Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test |
| Immunological calibrator (strip) | Calibrator (strip) | Calibrator for Immunological |
| Immunological calibrator (liquid) | Calibrator (cair) | Calibrator for Immunological |
3. Category Reassignment for Immunological Calibrators
This update goes beyond a name change: the category and subcategory for immunological calibrators have also changed, while the risk class remains Class B.
| Item | Before | After |
|---|---|---|
| Product type | Calibrator (strip), Calibrator (cair) | Calibrator for Immunological |
| Category | Clinical chemistry and clinical toxicology devices | Immunology and microbiology devices |
| Subcategory | Clinical chemistry test systems | Immunological test systems |
| Risk class | Class B | Class B (unchanged) |
4. How to Handle Products with Existing Registrations
1. Existing registrations remain valid until expiry
Medical device marketing authorisation numbers (NIEs) issued before this classification update took effect remain valid until the registration certificate expires, even if they still use the previous product type name.
2. Product names can be updated through a variation or renewal application
NIE holders may use a variation application and/or a renewal application, in accordance with current regulations, to update the product type name and make the corresponding changes to the NIE.
5. Four Recommendations for Manufacturers
- Review existing registrations: Check each product against the annex to the circular to determine whether it is affected by the update, with particular attention to multiplex respiratory nucleic acid tests, immunohistochemistry reagents and nucleic acid tests for the Mycobacterium tuberculosis complex.
- Confirm the product risk class: Products within the same broad category may have different risk classes. Verify the class against the specific intended use and product type rather than applying the class of another similar product by default.
- Assess the timing of name updates: Taking into account the validity period of the existing NIE and plans for subsequent variations or renewals, assess whether and when the product type name should be updated.
- Check the classification before new applications: Prepare submission materials using the updated system classification information and avoid using obsolete product type names that no longer apply.
This article is based on the Indonesia Ministry of Health circular dated 16 October 2026 and its annex. It is provided for general industry reference only and does not constitute legal or regulatory advice. Product-specific classification and procedural requirements are subject to the latest information published by the Indonesia Ministry of Health and the Regalkes system.