The duration of the process for Class A medical device registration with Indonesia's Ministry of Health (MOH) typically takes between 1 to 3 months. However, this timeline can vary depending on several factors, such as the completeness of the application, the review workload of the regulatory bodies, and whether additional documentation or clarifications are required.

Here’s a breakdown of the typical stages and time estimates:

1. Preparation of Documents (1-2 weeks)

• Collecting and preparing the required documentation (e.g., Certificate of Free Sale, ISO 13485 certificate, labeling in Bahasa Indonesia) usually takes 1 to 2 weeks, depending on how quickly the manufacturer can provide the necessary documents.

2. Submission of Application (via e-Registration Portal)

• Once all documentation is ready, the local representative submits the registration application via the BPOM e-Registration portal. This submission is typically done within a day or two.

3. Review Process (1-2 months)

• BPOM or the Ministry of Health (MOH) will evaluate the submitted documents for completeness, accuracy, and compliance with Indonesian regulations.
• The review period for Class A devices tends to be shorter compared to higher-risk classes. It typically takes 1 to 2 months. If the authorities find that additional information is needed or if any document is missing, this could extend the timeline.

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

• After the application is approved, BPOM/MOH issues the Izin Edar (distribution license). This is typically completed within 1 to 2 weeks after the approval is granted.

Total Estimated Time: 1 to 3 months

• The entire process from submission to issuance of the distribution license usually takes around 1 to 3 months, assuming that there are no significant delays or additional requirements.

Factors that May Impact the Timeline:

1. Completeness of Application: Missing or incomplete documentation can cause delays.
2. BPOM/MOH Review Capacity: The workload of the regulatory bodies at the time of submission can affect how long it takes to process the application.
3. Clarifications: If BPOM or MOH requests additional information or clarification, the process may take longer.

By ensuring that all documentation is complete, accurate, and complies with local regulations, the timeline can generally be kept within the 1 to 3-month range.