The process of applying for B-class medical device registration with the Ministry of Health (MOH) in Indonesia, through the National Agency of Drug and Food Control (BPOM), typically takes around 2 to 4 months. However, this timeline can vary depending on factors such as the complexity of the device, the completeness of the application, and BPOM’s workload.

Here’s a breakdown of the application timeline and the steps included in the review process:

Timeline for B-Class Medical Device Registration

• Preparation Phase: Before you start the official registration process, you need to ensure all the necessary documentation is ready. This phase can take anywhere from a few weeks to a few months, depending on the device and how quickly the documents are gathered.

• Submission and Review: Once the application is submitted to BPOM, the actual review process for a B-class medical device typically takes around 2 to 4 months. This depends on factors like:

  • The complexity of the device and the need for additional clarifications or data.
  • Whether BPOM requires any supplementary testing or information.
  • The completeness of the documents submitted.

• Issuance of Approval: If BPOM does not find any issues with the submission, approval can be granted relatively quickly after the review. You will receive the Surat Izin Edar (SIE) within the processing time mentioned above.

Steps Included in the Review Process

The BPOM review process for B-class medical device registration typically includes the following steps:

1. Document Verification

• Completeness Check: BPOM will verify whether all required documents have been submitted. This includes ensuring that the application form, technical documentation, certificates, labeling, and other required documents are present and complete.

• Eligibility for Registration: BPOM will confirm that the device is eligible for B-class classification. B-class devices are typically low to medium-risk, so BPOM will ensure that your device falls under this category according to the Indonesian Medical Device Classification Guidelines.

2. Technical and Clinical Evaluation

• Technical Evaluation: BPOM’s technical team reviews the device’s technical file, which includes product specifications, design, intended use, risk management files, and testing reports (such as biocompatibility, electrical safety, and performance). They will evaluate whether the device meets the Indonesian safety and efficacy standards.

• Clinical Data Review: If the device requires clinical data, BPOM will evaluate the clinical trial results or performance data submitted to ensure the device’s safety and effectiveness in the intended clinical setting. The amount of clinical data required can vary depending on the nature of the device.

3. Labeling and Packaging Review

• BPOM will verify the labeling and packaging of the medical device to ensure that they meet the Indonesian regulations. This includes checking the language requirements (which must include Bahasa Indonesia), proper labeling of risk warnings, usage instructions, and other regulatory information.

4. Manufacturer Compliance Check

• GMP Compliance: If the device is manufactured overseas, BPOM will verify the Good Manufacturing Practices (GMP) certification of the manufacturing facility. This is crucial for ensuring that the device is manufactured according to the required quality standards.

• Certification of Free Sale (CFS): BPOM may require a Certificate of Free Sale from the country of origin, confirming that the device is legally sold and marketed in the home country or in other markets.

5. Risk Assessment and Quality Control

• BPOM will assess the risk management documentation to ensure that the device is safe for use and that adequate risk control measures are in place. This involves reviewing the risk analysis, mitigation strategies, and testing results for any potential hazards associated with the device.

6. Additional Testing (If Required)

• Post-market surveillance or additional testing may be requested by BPOM in certain cases. For example, if the device is subject to specific health or safety concerns, BPOM may ask for additional performance or safety testing data.

7. Final Evaluation and Decision

• After completing the evaluations, BPOM will decide whether to approve or reject the application.
  • Approval: If the application meets all regulatory requirements, BPOM will approve the registration and issue the Surat Izin Edar (SIE), allowing the device to be marketed in Indonesia.
  • Rejection: If BPOM identifies deficiencies in the documentation or finds issues with the safety or efficacy of the device, the application will be rejected, and the applicant will be asked to provide additional information or rectify the issues.

8. Post-Approval Monitoring (if applicable)

• Post-market surveillance will be required once the device is on the market. BPOM may conduct inspections or require periodic reports on the device’s performance, especially if any adverse events are reported.

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