The processing time for D-class medical device registration in Indonesia through the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) typically ranges between 2 to 6 months. However, the exact duration can vary depending on several factors. Here's a breakdown of what influences the processing time:

Factors Affecting Processing Time:

1. Completeness and Accuracy of the Application:

   • If your application is complete, with all required documents properly filled out and submitted, the review process will likely be quicker.
   • Missing or incomplete documents may lead to delays, as BPOM will request additional information or clarification.

2. Device Classification:

   • Since D-class devices are considered low-risk, they typically undergo a faster review process compared to higher-risk devices (like Class II or III). The D-class devices usually have a more streamlined evaluation.

3. BPOM’s Review Process:

   • BPOM will review all submitted documents to ensure they comply with Indonesian medical device regulations.
   • If there are no issues, BPOM can approve the registration in a relatively short time, typically within 3 to 4 months.
   • If there are any discrepancies or if BPOM needs additional information or documentation (such as more evidence to classify the device as low-risk), this could extend the review time.

4. Current Processing Load at BPOM:

   • The volume of applications BPOM is handling at any given time can impact how long your registration will take. During periods with a high volume of submissions, processing times may be longer.

5. Communication and Clarifications:

   • If BPOM requests clarifications or additional documents, this can add time to the overall process. The quicker you respond, the faster the process will move forward.

Typical Timeline:

• Initial Review: BPOM usually conducts the initial review within 1 to 2 months after submission.
• Additional Requests: If BPOM requests additional information or documents, it may take another 1 to 2 months for you to provide the required details and for BPOM to conduct a secondary review.
• Final Approval: Once all requirements are met, BPOM typically issues the Certificate of Registration within 1 to 2 months.

Estimated Total Time:

• The overall processing time for D-class device registration is usually between 2 to 6 months. If there are no delays or issues, it could be completed closer to 2 to 3 months. However, if additional documentation or clarifications are needed, it could take closer to 6 months.

Tips to Ensure a Smoother Process:

1. Complete Documentation: Make sure that all documents are correct, up-to-date, and in the required format. Missing or incorrect documents are a common cause of delays.
2. Local Representation: If you're a foreign manufacturer, make sure that your local authorized representative is well-prepared to handle the application and any additional requests from BPOM.
3. Prompt Response: If BPOM requests any clarification or additional documentation, provide it as quickly as possible to avoid further delays.

By following the proper registration procedures and ensuring that your application is complete, you can expect a processing time of approximately 2 to 6 months for a D-class medical device in Indonesia.

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