The process of obtaining Class II medical device registration with the Indonesian Ministry of Health (MOH) through BPOM typically takes 3 to 6 months. The timeline can vary depending on several factors, including the complexity of the device, completeness of the submitted documentation, and BPOM’s review workload. Here's a breakdown of the key stages and factors that influence the timeline:

1. Submission and Document Review (1–2 Months)

• Initial Submission: The first step involves submitting all required documentation, including technical files, clinical data (if applicable), ISO certifications, and product information. This can take a few weeks to prepare, depending on the complexity of the device.
• Document Review: BPOM will review the submitted documents for completeness and compliance with Indonesian regulations. BPOM may request additional information or clarifications during this stage, which could extend the review time.

2. Evaluation and Technical Assessment (1–2 Months)

• Technical Evaluation: BPOM conducts a detailed evaluation of the device to assess its safety, efficacy, and quality based on the documentation provided. This may involve consulting with experts or referring to international standards.
• If the device requires additional testing or certifications (e.g., clinical trials, performance testing), this could extend the evaluation process.

3. Approval and Registration (1 Month)

• Final Decision: If the technical evaluation is successful, BPOM will issue the registration certificate, officially granting approval for the device to be marketed and sold in Indonesia. The time for approval typically takes about a month after the evaluation is complete.
• Post-Approval Notifications: Once approved, BPOM will notify the manufacturer or their authorized representative. After this, the manufacturer can begin importing and distributing the device in Indonesia.

Factors That May Affect the Timeline:

1. Completeness of Documentation: If there are issues or missing information in the initial application, BPOM may request further details, which could delay the process.
2. Device Complexity: Devices that involve higher risk or more complex technology may require additional assessments or testing, which can extend the review timeline.
3. BPOM's Workload: The time it takes for BPOM to process applications can vary depending on the volume of applications they are handling at the time.
4. Local Representation: Manufacturers must have a local authorized representative in Indonesia, and any delays in appointing this representative or communicating with them could extend the timeline.

Summary Timeline:

• Preparation and Submission: 2–4 weeks (depends on readiness of documents)
• Document Review and Evaluation: 1–2 months
• Approval and Registration: 1 month
• Total Estimated Time: 3 to 6 months

By ensuring that all required documents are complete and accurate, and by working with a local authorized representative who is familiar with the process, the timeline for obtaining Class II medical device registration in Indonesia can be streamlined.

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