Cost and Timeline for Class A Medical Device Registration with Indonesia MOH

1. Cost

The cost for registering a Class A medical device in Indonesia depends on several factors, including the type of device and specific fees set by the Ministry of Health (MOH). Typically, the costs include:

1. MOH Registration Fee:

   • The registration fee for Class A devices is generally lower compared to higher-risk devices (Classes B, C, and D). The specific amount can range from USD 100 to USD 300, depending on the device.

2. Consultant or Local Representative Fee (if applicable):

   • If you engage a regulatory consultant or local distributor to handle the registration process, additional fees may apply. These fees typically range from USD 500 to USD 2,000, depending on the service provider.

3. Document Preparation and Translation:

   • Costs for translating documents (e.g., IFUs, labels) into Bahasa Indonesia.
   • Approximate cost: USD 200 to USD 500.

4. Testing Costs (if required):

   • If safety or performance testing is required, costs depend on the nature of the tests.

Total Estimated Costs:

• USD 800 to USD 2,800, including all fees and services.

2. Timeline

The timeline for Class A medical device registration is shorter than for higher-risk devices because of the simplified review process. The general timeline is as follows:

1. Preparation of Documentation:

   • Time: 1–4 weeks (depending on document availability and translation needs).

2. Submission via ASPAK Portal:

   • Time: Immediate, assuming documents are ready and complete.

3. MOH Review and Approval:

   • For Class A devices, the MOH typically completes the review within 1–3 months.
   • Any additional queries or requests for clarification can extend this timeline.

Key Factors Affecting Cost and Time

• Completeness of Documentation: Missing or incomplete documents can delay the process.
• Experience of Local Representative: An experienced authorized representative can expedite the application.
• MOH Workload: The time required may vary based on the volume of applications being processed.

Would you like assistance estimating specific costs for your product or navigating the registration timeline?

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