May 09, 2025

Indonesia, Southeast Asia’s most populous country, is rapidly modernizing its healthcare system and expanding access to advanced medical technologies. For medical device manufacturers, Indonesia offers significant market potential-but only for those who can successfully navigate its regulatory environment. Registering Class II and III medical devices, which carry moderate to high risk, requires careful planning, thorough documentation, and ongoing compliance.

Medical Device Classification in Indonesia

Medical devices in Indonesia are regulated by the National Agency of Drug and Food Control (BPOM, or Badan Pengawas Obat dan Makanan). Devices are classified by risk:

  • Class I: Low risk (e.g., bandages)
  • Class II: Moderate risk (e.g., infusion pumps, diagnostic kits)
  • Class III: High risk (e.g., heart valves, implantable devices)
  • Class IV: Special risk (e.g., cutting-edge or combination devices)

Class II and III devices are subject to more rigorous scrutiny due to their greater potential impact on patient health.

Regulatory Requirements for Class II & III Devices

1. Appoint a Local Authorized Representative

Foreign manufacturers must appoint a local authorized representative (LAR) in Indonesia. The LAR acts as the official liaison with BPOM, submits the registration, and ensures ongoing compliance.

2. Pre-market Approval and Documentation

Both Class II and III devices require pre-market approval. The process involves submitting a comprehensive application via BPOM’s online system. Key documents include:

  • Device Registration Form: Completed online.
  • Certificate of Free Sale (CFS): Proof the device is legally sold in its country of origin.
  • Product Specifications: Detailed description, intended use, and technical data.
  • Quality Management System (QMS) Certificate: ISO 13485 certification is typically required, especially for Class III.
  • Clinical Data: Required for Class III devices to demonstrate safety and effectiveness.
  • Risk Management Documentation: Analysis of potential hazards and mitigation strategies.
  • Labeling: Must comply with BPOM requirements and be in Bahasa Indonesia.
  • Local Authorized Representative Details: Contact and licensing information.

3. Evaluation and Approval

BPOM reviews the submission for completeness and compliance. For Class II devices, the process is generally faster, but for Class III, expect a more in-depth review, including assessment of clinical data and risk management reports. Approval timelines can range from a few months (Class II) to six months or more (Class III).

4. Registration Certificate

Upon approval, BPOM issues a Medical Device Registration Certificate, valid for five years. This certificate allows the device to be legally marketed in Indonesia. Renewal requires updated documentation and evidence of continued safety and efficacy.

Post-Market Surveillance and Compliance

Regulatory obligations do not end at approval. Manufacturers and their LARs must:

  • Report Adverse Events: Any incidents or safety concerns must be promptly reported to BPOM.
  • Submit Periodic Safety Updates: BPOM may require regular reports on device performance and safety.
  • Maintain Traceability and Recall Plans: Especially for Class III devices, manufacturers must have systems in place for tracking and recalling products if needed.
  • Undergo Audits and Inspections: BPOM conducts routine and unannounced inspections to ensure ongoing compliance.

Conclusion

Registering Class II and III medical devices in Indonesia is a multi-step process requiring detailed preparation, local representation, and ongoing vigilance. By understanding BPOM’s requirements and maintaining strong post-market compliance, manufacturers can unlock Indonesia’s growing healthcare market while ensuring patient safety and regulatory success.