The processing time to obtain Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether additional documentation or inspections are required. However, here is a general estimate of the time frame:

Typical Processing Time for Class C Medical Device Registration in Indonesia:

• 3 to 6 months: On average, the process to obtain Class C medical device registration typically takes around 3 to 6 months. This period includes the time for BPOM to review the application and make a decision on whether the device complies with the required safety, efficacy, and quality standards.

Factors Influencing Processing Time:

1. Completeness of Application:

   • If the application is complete and all required documents are submitted without missing information, the review process will be quicker.
   • Missing or incomplete documents can lead to delays, as BPOM may request additional information or clarification from the manufacturer.

2. Device Complexity:

   • The registration of more complex devices, such as diagnostic or therapeutic equipment, may take longer due to the need for more in-depth evaluation of clinical data, risk management plans, and manufacturing practices.
   • Simpler, low-risk devices might be processed faster than high-risk, sophisticated devices.

3. Clinical Data and Risk Management:

   • If the device requires clinical data or comprehensive risk management documentation (such as ISO 14971 compliance), this may add time to the review process as BPOM will thoroughly evaluate the safety and performance data provided.

4. Inspection of Manufacturing Facility (if applicable):

   • For foreign manufacturers, BPOM may require a GMP inspection of the manufacturing facility. This can add time, especially if the facility is located abroad and an inspection visit is required.
   • The availability of international certifications (e.g., FDA, EMA) may help expedite the process if BPOM accepts those certifications as part of the evaluation.

5. Requests for Additional Information:

   • If BPOM finds any issues or requires clarification on certain aspects of the application, it may request additional documentation or updates to the information provided, which can extend the processing time.

6. Backlog at BPOM:

   • If there is a backlog of medical device registrations at BPOM, it could increase the processing time for all applications. It is advisable to consult with BPOM or a local regulatory consultant to check the current processing times.

Steps in the Review Process and Timeline:

1. Initial Review (1-2 weeks):

   • BPOM conducts an administrative review to ensure that all required documentation has been submitted.

2. Technical and Scientific Evaluation (2-4 months):

   • BPOM reviews the technical documentation, clinical data, quality management system, and risk management information.
   • The review time may vary depending on the complexity of the device and the completeness of the documentation.

3. Good Manufacturing Practice (GMP) Inspection (if required) (Variable):

   • If the device is manufactured outside Indonesia, BPOM may require a GMP inspection of the facility. The inspection process may add additional time, especially if the facility is located outside Indonesia.

4. Approval and Issuance of Registration Certificate (1-2 weeks):

   • Once the technical review is completed and BPOM is satisfied with the documentation, they will issue the Marketing Authorization Number (NOM) and Registration Certificate.
   • The device is then legally allowed to be sold and distributed in Indonesia.

How to Expedite the Process:

• Submit Complete and Accurate Documentation: Ensure that all required documents are provided in the correct format and that all information is accurate.
• Pre-Consultation: If you're unsure about the requirements, consider consulting with BPOM or a local regulatory consultant in advance to ensure you're submitting the right information.
• Prepare for GMP Inspections: If your manufacturing facility is located outside Indonesia, ensure that your GMP certification is current and from a recognized authority.
• Monitor BPOM Processing Times: Be aware of any potential delays or backlogs at BPOM and plan accordingly.

In Summary:

The typical processing time for obtaining Class C medical device registration in Indonesia is 3 to 6 months, depending on the device's complexity, the completeness of the application, and whether additional inspections or documentation are required. Preparing a complete and accurate application and being proactive in addressing any potential issues can help expedite the process.

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