The review timeline for Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) typically takes about 3 to 6 months, depending on the complexity of the device and the completeness of the application. However, this can vary based on several factors, such as the accuracy of your submission, the need for additional information, or inspections.

Key Stages in the Review Process

Here’s a breakdown of the main stages involved in the review process, including the typical timeline for each stage:

Stage 1: Application Submission

• Timeline: Immediate
• Process:
  • The applicant (manufacturer or authorized representative) submits the registration application through BPOM's online portal or e-licensing system. This includes all necessary documentation, such as product specifications, certificates, risk management reports, clinical evaluation data (if applicable), and GMP certifications.
  • BPOM confirms receipt of the application. Any issues or missing documents will typically be identified during the initial review.

Stage 2: Initial Document Review by BPOM

• Timeline: 1 to 3 weeks (can vary depending on complexity)
• Process:
  • BPOM begins reviewing the submitted documents for completeness and compliance with Indonesian regulatory requirements.
  • BPOM checks that all required documents are provided, including:
    • Application form and certificate of free sale (CFS).
    • ISO certifications, clinical data, and technical specifications.
    • Post-market surveillance plan (if applicable).
    • Risk management documentation.
  • Outcome:
    • If all documents are in order, BPOM proceeds to the next stage.
    • If there are missing documents or issues, BPOM will request additional information or clarification, which could delay the process.

Stage 3: Technical and Safety Evaluation

• Timeline: 4 to 8 weeks (can vary)
• Process:
  • BPOM conducts a detailed evaluation of the product's safety, efficacy, and regulatory compliance.
  • This includes reviewing the technical characteristics, risk management, clinical evaluation reports (if applicable), and the manufacturer’s adherence to international standards (e.g., ISO 13485, ISO 14971).
  • BPOM may also assess the labeling, including whether it meets the required Bahasa Indonesia translation, and ensure that the instructions for use (IFU) comply with local standards.

Stage 4: GMP and Manufacturing Site Inspection (if required)

• Timeline: Varies (usually additional 4-6 weeks if an inspection is needed)
• Process:
  • For Class II devices, BPOM may require an inspection of the manufacturing facility to ensure Good Manufacturing Practices (GMP) are followed.
  • If the manufacturer is located outside Indonesia, BPOM may request a GMP certification or conduct an offsite inspection. In some cases, BPOM may request a facility visit.
  • Outcome:
    • If the manufacturing site passes the inspection, BPOM proceeds with the evaluation.
    • If issues are found, the manufacturer must implement corrective actions, which could delay approval.

Stage 5: Review of Additional Documentation or Modifications

• Timeline: 2 to 4 weeks (if applicable)
• Process:
  • If BPOM requests additional documents, modifications to the product, or clarifications, the applicant must provide this information.
  • This stage can delay the process if the applicant takes time to respond or if the new information requires further evaluation.

Stage 6: Final Review and Approval Decision

• Timeline: 2 to 4 weeks
• Process:
  • Once BPOM has all the necessary documentation, evaluations, and inspection results (if applicable), the final review is conducted.
  • BPOM makes a decision based on the device's compliance with Indonesian medical device regulations and its safety and efficacy profile.
  • If BPOM is satisfied, they will approve the registration and issue a registration certificate for the medical device.

Stage 7: Issuance of Registration Certificate

• Timeline: Immediate (after approval)
• Process:
  • After final approval, BPOM issues the registration certificate, which authorizes the device to be marketed and sold in Indonesia.
  • The registration certificate is valid for 5 years and must be renewed before expiration.

Overall Timeline Estimate

• Overall Timeline:
  • The total review process from application submission to certificate issuance typically takes about 3 to 6 months.
  • Delays may occur if additional information or documents are required, or if an inspection is needed.
• Factors That Can Affect the Timeline:
  • Completeness and accuracy of the application.
  • The complexity of the device and its regulatory requirements.
  • The need for additional clinical data, inspections, or clarifications.
  • The response time of the manufacturer to BPOM’s requests for further information.

Additional Considerations

• Expedited Review: BPOM may expedite the review process for certain devices if they meet certain criteria, such as being essential for public health emergencies or for high-demand devices.
• GMP Compliance: Devices manufactured in Indonesia or by foreign manufacturers must be in compliance with Good Manufacturing Practices (GMP), which is an important part of the evaluation. Non-compliance with GMP may cause delays or refusal of registration.
• Post-Market Surveillance (PMS): After registration, the manufacturer must implement a post-market surveillance plan, reporting any adverse events or device failures to BPOM as part of ongoing compliance.

Summary of Review Timeline for Class II Medical Device Registration in Indonesia MOH

1. Application Submission: Immediate.
2. Initial Document Review: 1 to 3 weeks.
3. Technical and Safety Evaluation: 4 to 8 weeks.
4. GMP and Site Inspection (if required): Additional 4-6 weeks.
5. Review of Additional Documentation/Modifications: 2 to 4 weeks (if applicable).
6. Final Review and Approval Decision: 2 to 4 weeks.
7. Issuance of Registration Certificate: Immediate after approval.

Total Review Time: Approximately 3 to 6 months, depending on various factors.

Let me know if you need more details on any particular stage of the process!

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