The time cycle for applying for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM) can vary depending on the complexity of the device, the completeness of your submission, and BPOM’s workload. However, the typical time frame for the entire process is generally between 6 months to 12 months, with some cases taking longer if additional information or inspections are required.

Here is an overview of the stages of the review process and the approximate time needed at each stage:

Stages of the Review Process for Class 3 Medical Device MOH Registration in Indonesia

1. Initial Document Submission (2-4 Weeks)

• Submit Application: After preparing all necessary documentation (clinical data, technical files, risk management reports, quality certificates, labeling, etc.), the applicant (or the local authorized representative) submits the application through BPOM’s e-registration system or directly to BPOM.
• Document Verification: BPOM will first verify if the application is complete. This stage involves ensuring that all required documents are submitted and meet the necessary regulatory requirements.
• Timeframe: This step usually takes about 2 to 4 weeks, depending on the complexity of the documentation and BPOM’s workload.

2. Evaluation of the Application (3-6 Months)

Once the application has been submitted and verified, BPOM begins the evaluation process, which includes several sub-steps:

a) Technical Review:

• BPOM will assess the technical documentation of the device, including the risk management plan, clinical data, performance testing, and compliance with relevant standards (e.g., ISO 13485, ISO 14971, etc.).
• For Class 3 devices, which are high-risk, BPOM may require additional clinical data or reports from previous clinical trials to verify the device’s safety and efficacy.

b) Labeling and Packaging Review:

• BPOM will review the labeling (including instructions for use) and packaging of the device to ensure it complies with Indonesian regulations, including language and safety information requirements.

c) Risk Assessment and Review of Post-Market Surveillance:

• BPOM will evaluate whether the post-market surveillance plan and adverse event reporting mechanisms are appropriate.

d) Manufacturer Facility Inspection (if required):

• Depending on the nature of the device, BPOM may decide to inspect the manufacturing facility or the local distributor. If the device is manufactured abroad, BPOM might request a Good Manufacturing Practice (GMP) inspection at the facility.

e) Consultation and Expert Review (if applicable):

• For some Class 3 devices, particularly those with new technologies or significant risks, BPOM may consult with external experts or an advisory committee to assess the device's safety and efficacy.

• Timeframe: This stage can take between 3 to 6 months, depending on the complexity of the device, the need for expert consultations, and the completeness of the submitted information.

3. Additional Documentation or Clarifications (1-2 Months)

• BPOM Feedback: During the evaluation process, BPOM may request additional information or clarifications on specific aspects of the application (e.g., more data on clinical trials or safety studies, further details on the manufacturing process, etc.).

• Response Time: The applicant (or authorized representative) must respond promptly to these requests. Delays in responding or submitting additional documents can extend the review process.

• Timeframe: If BPOM requests additional documents or clarifications, the response time may take 1 to 2 months, depending on how quickly the applicant can gather and submit the required information.

4. Payment of Registration Fees (1-2 Weeks)

• Once BPOM completes its evaluation and is ready to approve the registration, they will issue an invoice for the registration fee. The applicant must then pay this fee within the specified time frame.

• Timeframe: This payment process usually takes about 1 to 2 weeks. Delays in payment can result in further delays in the registration process.

5. Registration Approval (1-2 Months)

• Approval and Issuance of Registration Certificate: Once the fee is paid, and all requirements are met, BPOM will issue the registration certificate for the Class 3 medical device. This confirms that the device has been approved for sale and distribution in Indonesia.

• Timeframe: The final approval process can take 1 to 2 months, depending on BPOM’s workload and any final administrative steps.

6. Post-Registration Requirements

Once the registration is approved, ongoing compliance requirements, including post-market surveillance, are essential to maintaining the registration. This includes:

• Adverse Event Reporting: Mandatory reporting of any adverse events or device malfunctions.
• Annual Reporting: Submission of regular updates to BPOM on the device’s safety and performance.
• Re-registration (Every 5 Years): Class 3 devices must be renewed every five years.

Total Time Frame for Class 3 Medical Device Registration

• Typical Time Cycle: The overall registration process for a Class 3 medical device in Indonesia typically takes between 6 to 12 months, depending on factors such as:
  • The completeness of the documentation.
  • BPOM’s review timelines.
  • Whether additional inspections or clarifications are required.
• Factors that may cause delays:
  • Incomplete or incorrect documentation: If there are issues with the application, BPOM may request additional information, causing delays.
  • Complexity of the device: For high-risk devices, especially those requiring clinical trials or additional expert review, the process can take longer.
  • Inspection requirements: If BPOM requests an inspection of the manufacturing facility, this may add additional time.

Conclusion

The process of applying for Class 3 medical device registration with BPOM in Indonesia is thorough and can take anywhere from 6 months to a year to complete, depending on various factors. The stages include documentation submission, technical review, possible inspections, payment of fees, and final approval. Starting the process early and ensuring that all documentation is complete and accurate will help minimize delays in the registration process.

If you need further details on any specific stage, feel free to ask!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn