The processing time for 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 information or inspections are required. However, here is a general overview of the expected processing time:

Typical Processing Time:

• 3 to 6 months: On average, the registration process for Class C medical devices takes 3 to 6 months from the submission of the application to the issuance of approval by BPOM.
  • 3 months: If all documentation is complete, accurate, and the device does not require additional inspections or clarifications.
  • 6 months: If additional documentation is needed, there are requests for clarification, or if the device requires a Good Manufacturing Practice (GMP) inspection (especially for foreign manufacturers).

Factors That May Affect Processing Time:

1. Completeness of the Application:

   • If the application is complete and all necessary documents are provided (device descriptions, clinical data, risk management reports, certifications, etc.), the process will be quicker.
   • Missing or incomplete documents can delay the review process as BPOM may request additional information or clarification.

2. Device Complexity:

   • More complex devices, such as diagnostic or therapeutic equipment, may require more in-depth review and evaluation, leading to longer processing times.

3. Clinical Data Evaluation:

   • If the device requires clinical trial data or clinical performance evidence, the review may take longer. The regulatory review team will need to thoroughly assess the safety and effectiveness of the device.

4. Inspection of Manufacturing Site (if applicable):

   • For foreign manufacturers, BPOM may require a GMP inspection of the manufacturing facility. The inspection process, especially if it involves international coordination, can add time to the overall approval process.
   • If the facility is certified by other recognized authorities (e.g., FDA, EMA, or PMDA), this may speed up the process.

5. Request for Additional Information:

   • BPOM may request further clarifications or additional documentation during the review process, which could delay the approval timeline.

Steps Involved in the Review Process:

1. Administrative Review (1-2 weeks): BPOM checks the completeness of the application and verifies if all required documents have been submitted.
2. Technical and Scientific Review (2-4 months): BPOM evaluates the technical aspects of the device, including clinical data, risk management, and compliance with international standards like ISO 13485 and ISO 14971.
3. GMP Inspection (if required) (Variable): If the device is manufactured outside of Indonesia, a GMP inspection may be requested. Depending on the location and logistics, this step may add several weeks to the processing time.
4. Approval and Issuance of Marketing Authorization (1-2 weeks): After the review is complete and BPOM is satisfied with the application, the Marketing Authorization (NOM) and Registration Certificate will be issued.

How to Minimize Delays:

• Ensure Completeness: Submit all required documents in the correct format and avoid missing information. Double-check that all documentation is accurate and up-to-date.
• Clarify Early: If you are unsure about specific requirements or documents, seek clarification from BPOM or a local regulatory consultant before submitting the application.
• Prepare for GMP Inspections: If your manufacturing facility is located outside Indonesia, ensure that your GMP certification is current and from a recognized authority. You may also want to coordinate with BPOM early to understand the inspection process and timeline.

In conclusion, while the typical processing time for Class C medical device registration in Indonesia is 3 to 6 months, it can be faster or slower depending on factors such as document completeness, the complexity of the device, the need for GMP inspections, and any requests for additional information. Plan for potential delays and submit a thorough and well-prepared application to help ensure a smooth and timely process.

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