Key Testing Requirements for IVDs

Indonesia has introduced new requirements under Ministry of Health Regulation No. 11 of 2025 (Permenkes No. 11/2025), which are being implemented progressively. The implementation of specific requirements will take effect following the issuance of the relevant decree or implementing decision.

To date, the implementation has been announced for In Vitro Diagnostic (IVD) medical devices, covering requirements related to performance testing, instrument requirements, and software validation. Manufacturers should assess the applicable testing and validation requirements based on the product type, intended use, and technology incorporated into the device.

1. Performance Testing for IVD Products

For In Vitro Medical Devices for Transfusion and Infectious Disease Screening (IMLTD), applicants are required to provide evidence demonstrating that the product meets the applicable performance requirements.

The supporting documentation should include:

• Documents demonstrating that the product’s sensitivity and specificity values meet the requirements for IMLTD screening in accordance with applicable regulations; and
• Validation test results issued by a laboratory or testing facility designated by the Ministry of Health.

For HIV-related medical devices, validation results for non-IMLTD products may be obtained from:

• An accredited laboratory in Indonesia;
• A certified testing facility; or
• A laboratory or testing facility in Indonesia designated by the Ministry of Health.

These requirements emphasize the importance of using appropriately recognized testing facilities when generating evidence for product registration and compliance.

List of laboratories or testing facilities designated by the Ministry of Health in Indonesia

Laboratory Name	Type of Testing
Balai Besar Laboratorium Biologi Kesehatan Jakarta	Malaria RDT
Balai Besar Biomedis dan Genomika Kesehatan Jakarta	RDT (COVID-19 Antigen, Anti-Syphilis (TP), Anti-HCV, HBsAg, Anti-HIV, Malaria) COVID-19 PCR Reagents, Blood Glucose POCT Reagents, TB Testing Reagents Endotoxin Test (Infusion Set, Disposable Syringe, Hypodermic Needle)
Balai Besar Laboratorium Kesehatan (BBLK) Surabaya	RDT (COVID-19 Antigen, Anti-Syphilis (TP), Anti-HCV, HBsAg, Anti-HIV) TB Testing Reagents
Balai Besar Laboratorium Kesehatan Masyarakat Makassar	RDT (Anti-Syphilis (TP), Anti-HCV, HBsAg, Anti-HIV) TB Testing Reagents
Balai Besar Laboratorium Kesehatan Masyarakat Palembang	TB Testing Reagents
Laboratorium Kesehatan Provinsi Jawa Barat	TB Testing Reagents
Unit Kerja Khusus Pelayanan dan Pengabdian Masyarakat Laboratorium Mikrobiologi Klinik Fakultas Kedokteran Universitas Indonesia (LMK FKUI)	COVID-19 Antigen RDT, COVID-19 PCR Kit TB Testing Reagents
RumahSakit Universitas Indonesia- Unit Laboratorium Terpadu	RDT (COVID-19 Antigen, Anti-Syphilis (TP), Anti-HCV, HBsAg, Anti-HIV), PCR Kit for SARS Detection
Fakultas Kedokteran Universitas Padjadjaran- Laboratorium Biomedik	RDT (COVID-19 Antigen, Malaria)
Universitas Padjajaran – Laboratorium Layanan Inovasi, Kesehatan, Keselamatan dan Lingkungan (HSE)	RDT (COVID-19, Malaria, Dengue, HBsAg, Prostate) PCR Kit for SARS Detection (Viral Transport Medium), COVID-19 Extraction Reagents, COVID-19 PCR Reagents Glucose Test Strips
PT Saraswanti Indo Genetech	Biocompatibility Test (Irritation, Sensitization, Cytotoxicity)

2. Instrument Validation for Devices with Wireless Connectivity

For IVD instrument incorporating Bluetooth, RFID, or Wi-Fi functionality, manufacturers should consider not only the IVD requirements but also the applicable telecommunications certification requirements in Indonesia.

• Applicants are required to provide a formal statement confirming that the applicant will undertake the necessary registration or certification for the relevant Bluetooth, RFID, and/or Wi-Fi functions with the Ministry of Communication and Digital Affairs (Komdigi). The statement letter can be issued by the manufacturer or the license holder.
• The applicable device certification application can be submitted through the Indonesian telecommunications equipment certification platform. Proof of the application to the Ministry of Communication and Digital Affairs shall be included as part of the device’s initial registration submission to the Ministry of Health (MoH).

Manufacturers should therefore identify wireless communication functions at an early stage of the registration process to ensure that the relevant certification activities can be planned alongside medical device registration.

3. Software Validationy

For IVD medical devices incorporating software, applicants should provide software validation test results and the corresponding certification in accordance with IEC 62304.

The validation should be conducted by an appropriately accredited laboratory or notified body.

The software validation documentation should include:

1. Software version and conformity assessment;
2. Defined acceptance criteria;
3. Test case list;
4. Test results;
5. Remaining anomalies, bugs, or test deviations; and
6. Validation conclusion.

A complete software validation package provides evidence that the software has been appropriately verified and validated for its intended function and supports the overall safety and performance of the medical device.

Apply now!

By identifying these requirements early and preparing the appropriate testing and validation evidence, manufacturers can reduce regulatory risks and support a more efficient registration process in Indonesia. Qualtech Consulting Corporation provides regulatory support for medical device manufacturers, including product classification, registration planning, technical documentation review, testing and validation assessment, and regulatory compliance strategy. As the implementation progresses, staying in touch with Qualtech can help you keep up with the latest regulatory requirements and prepare for the changes ahead.

Qualtech has been a trusted partner for medical device manufacturers for 26+ years. Whether you're a local startup or an international player, we empower your devices to enhance lives.

Contact us today here to unlock your medical device potential.
 

References

Ministry of Health Regulation No. 11 of 2025