The processing time for Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) can vary based on several factors such as the complexity of the device, the completeness of the submission, and whether any additional information or inspections are required. However, as a general guideline, the typical processing time is as follows:

Estimated Processing Time:

1. Initial Review and Submission: After submitting your application through BPOM’s e-Registration system, BPOM typically takes about 2 to 6 months to process the registration for Class C devices. This includes the time required for document verification, evaluation, and assessment of compliance with the required regulations.

2. Potential Delays: The processing time can be affected by:

   • The completeness of the documentation submitted (missing or incomplete documents will cause delays).
   • If additional information or clarifications are requested by BPOM.
   • If clinical trials, performance testing, or inspections are required for more complex devices, these may extend the processing time.
   • BPOM’s workload at the time of submission (e.g., regulatory backlogs can cause delays).

3. Issuance of Marketing Authorization (NOM): Once BPOM completes the review, the Marketing Authorization (NOM) can be issued, and this is typically done within 1-2 weeks after the review is completed, assuming there are no major issues with the application.

Factors Affecting Processing Time:

• Completeness of the Application: A complete and well-organized application will streamline the process and reduce the chances of delays. Make sure all required documents are properly filled out and all relevant certificates (e.g., Certificate of Free Sale (CFS), GMP, clinical evaluation data, etc.) are submitted.

• Type of Device: More complex Class C devices (e.g., surgical implants, diagnostic devices) may require additional evaluation, risk assessments, or even on-site inspections, which can extend the timeline.

• BPOM's Response Time: BPOM may request additional documentation or clarification on certain aspects of the application. The time taken for the applicant to respond will impact the overall processing time.

Steps to Expedite the Process:

1. Ensure Complete Documentation: Ensure that all required documents are prepared accurately and are complete (e.g., clinical data, performance test results, risk management file, labeling in Bahasa Indonesia).

2. Appoint a Competent Authorized Representative (AR): If you are a foreign manufacturer, working with a knowledgeable Authorized Representative (AR) in Indonesia can help avoid mistakes or delays in the application process.

3. Follow Up Regularly: After submitting the application, it’s a good practice to follow up regularly with BPOM or your AR to ensure there are no issues and to respond quickly to any requests for additional information.

Overall Timeline:

• The average processing time for Class C device registration is around 3 to 6 months, but depending on the factors mentioned above, it could take longer or shorter. Therefore, it is important to plan for this processing period when launching a medical device in Indonesia.

If you have any more specific questions about the process or need further assistance, feel free to ask!

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