The time it takes to obtain Class 3 medical device registration with the Indonesian Ministry of Health (MOH), specifically through the Badan Pengawas Obat dan Makanan (BPOM), typically ranges from 6 to 12 months. This can vary depending on several factors, such as the complexity of the device, completeness of the application, and BPOM’s workload. Here’s a general breakdown of the process and timeline:

Stages and Time Estimates for Class 3 Medical Device Registration in Indonesia

1. Preparation of Application Documents (1-2 months)

   • The first stage involves gathering and preparing the required documentation. This includes clinical data, performance testing, risk management reports, GMP certifications, labeling (in Bahasa Indonesia), and other regulatory documents.
   • The time for this phase can vary based on how quickly the required documents are gathered. If the manufacturer is already familiar with BPOM’s requirements, this process can take 1 to 2 months.

2. Initial Submission and Document Review (2-3 months)

   • Once the application is submitted to BPOM through their e-registration system, BPOM will conduct an initial review of the documents for completeness and compliance with regulatory requirements.
   • If the documents are complete and accurate, BPOM will move to the next stage of evaluation. If there are issues, BPOM may request additional information or clarifications, which can cause delays.
   • This phase typically takes around 2 to 3 months.

3. Clinical Data and Performance Evaluation (3-4 months)

   • BPOM will assess the clinical data, risk management, and performance testing results to determine whether the device meets the necessary standards for safety and efficacy. For Class 3 devices, this evaluation is particularly thorough and can take a bit longer.
   • If the device has already been marketed and approved in other countries, BPOM may take into account foreign clinical data or post-market surveillance data, which could shorten the review time.
   • This stage generally takes 3 to 4 months, but it could take longer if BPOM requires additional information or further consultation.

4. GMP Compliance and Inspection (if applicable) (1-2 months)

   • If the device is manufactured outside of Indonesia, BPOM may require an inspection of the manufacturing facility to ensure that it complies with Good Manufacturing Practices (GMP). If the facility has already been inspected and certified by a recognized authority (e.g., US FDA, European Union), this can expedite the process.
   • The inspection and review of GMP compliance can take 1 to 2 months, depending on the location of the manufacturing site and the availability of inspectors.

5. Final Approval and Registration (1-2 months)

   • After BPOM completes the evaluation of clinical data, performance testing, and GMP compliance (if applicable), they will issue the registration certificate if the device meets all necessary requirements.
   • This final approval process generally takes 1 to 2 months, but can be longer if any additional questions arise or if BPOM needs to review updated data or documentation.

Total Estimated Time for Registration:

• 6 to 12 months from the initial application submission to receiving the registration certificate.

Factors That Can Impact the Timeline:

• Completeness and accuracy of the submitted documentation (missing or incomplete data can delay the process).
• Clinical data requirements: If BPOM requires additional clinical trials or data, the review time could be longer.
• Foreign manufacturing site inspections: If your device is manufactured outside Indonesia, BPOM may require an inspection, which could extend the timeline.
• BPOM’s workload: The overall processing time can also depend on BPOM’s current workload and the number of applications being reviewed at the time.

Quickest Scenario:

• If all documents are in order and the device has already been approved in other markets (such as the US or EU), the process could take closer to 6 months.

Longest Scenario:

• If additional data or inspections are required (e.g., foreign GMP inspection or further clinical trials), the process could take up to 12 months or even longer.

By preparing all necessary documents thoroughly and ensuring compliance with BPOM’s requirements, you can help minimize delays and potentially shorten the registration time.

Let me know if you need more details on specific stages of the process!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn