Indonesia Updates IVD Medical Device Classification & Risk Classes

On October 16, 2026, Indonesia’s Ministry of Health issued Circular Letter No. FR.03.01/E.V/2204/2026, introducing significant revisions to the categories, subcategories, product types, and risk classes of in vitro diagnostic (IVD) medical devices.

These updates align Indonesian product nomenclature more closely with international standards and establish more precise product types to improve identification and grouping. The complete revised classifications and detailed product descriptions are available in the circular letter’s annex.

Key Changes to IVD Classifications

The official annex details 16 specific entries involving updates to product types, risk classes, or both. To help manufacturers and regulatory professionals navigate these updates, the primary modifications are categorized across several key diagnostic areas:

• Hepatitis B & C Tests: New product types explicitly distinguish traditional serological tests from nucleic acid tests (NAT), including specialized assays for viral load monitoring.
• HIV Tests: Classifications have been refined to separate viral load monitoring, serological diagnosis and supplemental testing, and NAT-based diagnostic testing.
• Respiratory Pathogen Tests: The classification for multiplex nucleic acid tests has been revised, resulting in a risk class upgrade from Class B to Class C.
• Immunohistochemistry Reagents: Previous classifications have been consolidated, moving reagents from Class A or B up to Class C.
• Tuberculosis Tests: Nucleic acid-based assays for detecting Mycobacterium tuberculosis complex — including those identifying associated antibiotic resistance mutations—have been reclassified from Class B to Class C.
• Immunology Calibrators: A distinct new product category has been established specifically for calibrators used in immunological testing.

Consult the official circular annex for the complete list of affected products, former versus revised nomenclature, and precise risk classes.

Impact on Existing Marketing Authorizations

The transition framework provides regulatory relief for current license holders while establishing clear compliance standards for upcoming submissions. Stakeholders should review the following operational guidelines for managing their documentation:

• Validity of Current NIEs: Existing marketing authorizations (Nomor Izin Edar, or NIE) issued prior to this update remain fully valid until their stated expiry dates, even if they utilize legacy product nomenclature. Holders are not required to replace an active NIE solely due to these classification revisions.
• Nomenclature Updates: Authorization holders may request nomenclature updates via standard regulatory pathways, such as through an amendment, a renewal, or a combined amendment and renewal application.
• New Applications: All incoming submissions must utilize the revised classifications. Manufacturers and distributors should cross-reference the annex with current registrations to identify nomenclature or risk class adjustments and plan necessary updates accordingly.

For companies managing IVD registrations in Indonesia, contact Cisema today to confirm the updated classification, assess existing NIEs and prepare the appropriate registration, amendment or renewal application.

About the Author: Elysabeth Septiani

Elysabeth Septiani is a Regulatory Affairs Manager at Cisema, Indonesia, overseeing regulatory strategy and compliance for medical devices, supplements, and cosmetic products. With eight years of experience in Regulatory Affairs and Quality Assurance, she specializes in regulatory submissions and intelligence, supporting efficient and compliant market access while ensuring alignment with evolving regulatory requirements.

Further Information

• Explore Cisema’s medical device and IVD registration services in Indonesia.
• Read Cisema’s guide to Indonesia medical device dossier preparation.

References

• Ministry of Health of the Republic of Indonesia, Circular Letter No. FR.03.01/E.V/2204/2026 regarding changes to the categories, subcategories, product types and risk classes of in vitro diagnostic medical devices.