The process of obtaining Class A medical device registration with Indonesia's Ministry of Health (MOH) typically takes around 1 to 3 months from the submission of the application to the issuance of the Izin Edar (distribution license). The exact duration can vary depending on several factors, such as the completeness of the application, the regulatory workload at the time, and whether any additional information is required.

Here’s a more detailed breakdown of the timeline:

1. Preparation of Documents (1-2 weeks)

• Gathering required documentation (e.g., Certificate of Free Sale, ISO 13485 certificate, labeling in Bahasa Indonesia) usually takes 1 to 2 weeks, depending on the readiness of the documents and the speed at which the manufacturer or local representative can provide them.

2. Submission of Application (1-2 days)

• Once the documents are prepared, the local authorized representative (distributor) submits the registration application through the e-Registration system.
• The actual submission process typically takes 1 to 2 days.

3. Document Review and Evaluation (1-2 months)

• After submission, BPOM or MOH will review the application and the supporting documents for completeness, compliance with regulations, and safety standards.
• For Class A devices, the review process is typically faster than for higher-risk devices, and it usually takes around 1 to 2 months.
• If any additional information or clarification is needed, the timeline may extend further.

4. Issuance of Izin Edar (1-2 weeks)

• Once the review is complete and the application is approved, the Izin Edar (distribution license) will be issued. This typically takes 1 to 2 weeks after approval.

Total Time Estimate: 1 to 3 Months

• From the submission of the application to the issuance of the Izin Edar, the entire process generally takes between 1 to 3 months.

Factors Affecting the Timeline:

1. Completeness of Application: If the application is missing documents or requires additional information, this can delay the process.
2. Regulatory Workload: The timeline can vary depending on the workload of BPOM or MOH at the time of submission.
3. Requests for Clarifications: If BPOM or MOH requests further clarifications or documents, it could extend the processing time.
4. Product Complexity: While Class A devices are lower-risk, more complex devices may take longer to review due to the need for additional technical documentation.

By ensuring all required documents are complete and meet Indonesian regulatory standards, the process can be completed more quickly, typically within the 1 to 3-month timeframe.

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