Indonesia Retires a Pandemic-Era Requirement for COVID-19 Antigen RDT Registrations

On April 22, 2026, Indonesia's Ministry of Health (MoH) issued Announcement No. FR.03.01/E.V/0636/2026. Effective immediately, it removes the requirement to submit validation test results for COVID-19 Antigen Rapid Diagnostic Test (RDT) products.

The policy applies to:

• New marketing authorization applications
• Marketing authorization renewal applications

The announcement replaces requirements established under Announcement No. FR.03.01/3/0134/2022 and reflects Indonesia's evolving post-pandemic regulatory landscape. The change follows Presidential Decree No. 17 of 2023, which officially ended Indonesia's COVID-19 pandemic status and transitioned disease management to the endemic phase.

The decision reflects current epidemiological conditions in Indonesia. COVID-19 case levels have declined significantly and remain under control, reducing the need for additional validation testing requirements introduced during the pandemic.

Impact for Manufacturers and Applicants

For manufacturers, importers, and distributors of [Medical Devices] and [In-Vitro Diagnostics (IVDs)], the update simplifies regulatory requirements for COVID-19 Antigen RDT products.

Applicants are no longer required to submit validation test results as part of registration or renewal dossiers, reducing administrative burden and potentially shortening submission timelines. Companies renewing existing marketing authorizations can also proceed without validation test documentation, streamlining the renewal process.

While this pandemic-era requirement has been removed, manufacturers remain responsible for complying with all applicable quality, safety, performance, and post-market obligations.

What This Means for Indonesia's Post-Pandemic Regulatory Direction

This announcement demonstrates Indonesia's continued move toward a more risk-based regulatory framework as pandemic-specific controls are reassessed and phased out. As COVID-19 becomes part of routine public health management, authorities are increasingly aligning requirements with current risk and public health priorities.

For companies operating in Indonesia, the update underscores the importance of closely monitoring regulatory developments, as additional temporary measures introduced during the COVID-19 public health emergency may continue to be reviewed or withdrawn.

For support navigating Indonesia's evolving medical device and IVD regulatory requirements, contact Cisema today.

Further Information

Explore Cisema’s services for medical device and IVD registration in Indonesia.

References

Ministry of Health Announcement No. FR.03.01/E.V/0636/2026 regarding the Adjustment of Product Testing Policy for COVID-19 Antigen Rapid Diagnostic Test (RDT).