The processing time for Class C medical device registration in Indonesia through the Ministry of Health (MOH), specifically BPOM (Badan Pengawas Obat dan Makanan), typically ranges from 3 to 6 months, depending on the complexity of the device, the completeness of the application, and the need for additional clarifications or inspections.

Review Steps and Timeline Breakdown for Class C Medical Device Registration

Here’s a step-by-step breakdown of the review process and expected timeline:

1. Pre-Application (Preparation Phase)

• Duration: Varies (1–3 months)
• Actions:
  • Classify the Device: Ensure the device is correctly classified as Class C and prepare the necessary documentation.
  • Appoint Local Representative: If you are a foreign manufacturer, appoint a local authorized representative or distributor.
  • Prepare Documents: Collect all required documentation, including device description, clinical data (if needed), ISO certifications, GMP certifications, labeling information, etc.

Note: The pre-application phase is flexible in terms of time. It depends on how quickly the manufacturer or authorized representative can gather and organize the required documents.

2. Submission of Application via BPOM e-Registration System

• Duration: 1–2 weeks
• Actions:
  • Online Submission: Submit the application through BPOM’s e-Registration system. This involves filling out an online form and uploading all required documents.
  • Payment of Fees: Pay the applicable registration fees through the portal.

Once submitted, the BPOM system will generate a receipt, and the review process will officially begin.

3. BPOM Initial Review

• Duration: 1–2 months
• Actions:
  • Document Check: BPOM will perform an initial review to verify that all required documents are submitted and properly filled out.
  • Administrative Review: BPOM will check for completeness and compliance with basic regulatory requirements. This includes ensuring that all documents are in Bahasa Indonesia where required (such as labeling) and verifying the local representative (if applicable).

If there are missing documents or if any clarification is needed, BPOM may request additional information from the applicant.

Possible Delays:

• If documents are incomplete or if BPOM requires clarification, the review may be delayed.

4. Technical and Scientific Evaluation

• Duration: 1–2 months
• Actions:
  • Evaluation of Device Specifications: BPOM will assess the device’s technical data, such as device performance, risk management reports, and clinical data (if applicable).
  • Review of Clinical Evidence: If the device is complex or has significant risks, BPOM will examine the clinical data provided to assess the safety and efficacy of the device.
  • ISO Certifications: BPOM will verify the compliance of the manufacturer with ISO 13485 (Quality Management Systems) and other relevant standards.
  • Risk Assessment: BPOM will review the Risk Management Plan following ISO 14971 to ensure that risks associated with the device have been identified and appropriately mitigated.

BPOM may request additional clinical trials or test data during this phase, which could extend the processing time.

5. GMP Inspection (if applicable)

• Duration: Varies (1–3 months)
• Actions:
  • If the manufacturing facility is located outside Indonesia, BPOM may request a GMP inspection.
  • Inspection Reports: BPOM will verify that the facility complies with Good Manufacturing Practices (GMP). They may either conduct the inspection themselves or rely on GMP certification from the relevant health authority of the manufacturing country (e.g., FDA or EMA certification).

Note: If the inspection is required, this phase can take longer, especially if the manufacturing site is overseas and requires travel arrangements or additional documentation.

6. Final Review and Decision

• Duration: 1–2 months
• Actions:
  • Final Review of Documents: BPOM will finalize their review of all submitted documentation, including the technical evaluation, GMP compliance, and risk management data.
  • Approval: If the review is successful and the device meets BPOM’s safety, quality, and efficacy standards, BPOM will issue the Marketing Authorization (NOM) and a registration certificate.
  • Notification: BPOM will notify the authorized representative or manufacturer of the approval, and the device will be registered for sale in Indonesia.

7. Post-Market Surveillance and Ongoing Compliance

• Ongoing: Continuous monitoring
• Actions:
  • After registration, the manufacturer is responsible for post-market surveillance, including adverse event reporting, product recalls (if necessary), and periodic renewal applications.

Expected Total Time for Processing

• Standard Timeframe: 3 to 6 months from the submission of the application to the issuance of the Marketing Authorization (NOM).
  • Best-case scenario: If all documents are complete and no issues arise, it may take closer to 3 months.
  • Worst-case scenario: If there are any issues requiring clarification or further documentation, it could extend to 6 months or longer.

Review Process Summary

1. Pre-Application Preparation: Duration varies, typically 1-3 months.
2. Application Submission: 1–2 weeks via BPOM e-Registration system.
3. Initial Administrative Review: 1–2 months.
4. Technical and Scientific Evaluation: 1–2 months.
5. GMP Inspection (if applicable): Varies, may take 1–3 months.
6. Final Review and Approval: 1–2 months.
7. Post-Market Surveillance: Continuous.

Key Factors that Affect Processing Time

• Completeness of the Application: Ensure all documents are in order to avoid delays.
• Complexity of the Device: More complex devices or those with significant risks may require more extensive review.
• Clinical Data: If clinical data is required, BPOM may take longer to assess it.
• GMP Inspection: If the manufacturer is overseas, it may take longer to complete the inspection and verification process.
• BPOM Workload: BPOM’s processing time may be affected by the volume of applications they are handling at any given time.

In summary, the review process for Class C medical device registration in Indonesia can take 3 to 6 months, depending on various factors, such as the completeness of the application, the complexity of the device, and any additional requirements (e.g., GMP inspections). Being prepared with all necessary documents and adhering to BPOM’s guidelines can help streamline the process.

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