After registering a Class 3 medical device with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM), the process does not end with the initial approval. There are periodic updates, renewals, and ongoing compliance requirements that manufacturers and authorized representatives must adhere to. Below are the key periodic updates and processes that you must follow to ensure your medical device remains compliant with Indonesian regulations:

1. Annual Maintenance of Registration

• Annual Fee Payment: BPOM charges annual registration fees for maintaining the device’s registration. Ensure that payments are made on time to avoid any interruptions in your device’s market availability in Indonesia.

• Annual Reporting: Manufacturers may need to submit an annual report detailing the device’s market performance, including any adverse events, complaints, or post-market surveillance findings. This report should reflect any updates on the safety and performance of the device.

2. Renewal of Registration (Every 5 Years)

• Registration Renewal: Medical device registration in Indonesia is typically valid for five years. Before the expiration date, you must apply for renewal to continue selling the device in the market. The renewal process generally involves submitting:

  • Updated clinical data (if applicable).
  • Evidence of continued compliance with quality standards (e.g., updated ISO 13485 certification).
  • Post-market surveillance data and adverse event reports from the past five years.
  • Updated labeling or packaging information (if changes have occurred).

• Document Submission: To renew the registration, you must submit the required documents to BPOM, including any updates, changes, or new information since the last registration.

• Timely Renewal: Ensure that you start the renewal process at least 6 months before the expiration date of your current registration to allow sufficient time for BPOM to review the application and avoid any market disruptions.

3. Periodic Reporting and Post-Market Surveillance

Class 3 medical devices are considered high-risk, so maintaining post-market surveillance is critical to ensuring the device continues to meet safety and performance standards. Key requirements include:

• Adverse Event Reporting: If any adverse events (e.g., malfunctions, injuries, or side effects) occur during the use of the device, these must be reported to BPOM within specific timelines (typically 15 days for serious incidents and 30 days for other issues).

• Field Safety Corrective Actions (FSCA): If any product safety concerns arise, you must implement corrective actions (e.g., device recalls or safety alerts) and inform BPOM accordingly. Detailed reports on the actions taken, including corrective measures, should be submitted.

• Annual Post-Market Surveillance Report: BPOM may require annual reports on the safety and effectiveness of the device based on real-world use. These reports should include:

  • Data on adverse events and complaints.
  • Updates on any corrective actions or recalls.
  • Any changes to the device’s performance or safety profile.

4. Notification of Changes to the Device

If any changes occur during the lifecycle of the medical device, these changes must be communicated to BPOM for review and approval before they can be implemented in the market. Changes may include:

• Changes in Design: If there are any significant changes in the device’s design or functionality, BPOM must be notified and may require new testing or clinical data.

• Changes in Manufacturing: If the manufacturing process or the manufacturer’s location changes, you must notify BPOM and provide updated documentation, such as GMP certification for the new facility.

• Changes in Intended Use: Any modification to the device’s intended use, indications, or target population requires BPOM approval.

• Changes in Labeling or Packaging: If the device labeling or packaging undergoes modifications (e.g., new languages, different warnings), these changes must be submitted for review to ensure continued regulatory compliance.

• Change in Authorized Representative: If you change your authorized representative in Indonesia, BPOM must be notified, and the new representative must submit the appropriate documents.

5. Quality Management System (QMS) Updates

To maintain regulatory compliance and meet BPOM’s standards, the manufacturer must continuously ensure that the Quality Management System (QMS) remains up to date. This includes:

• Annual QMS Audits: The manufacturer or its authorized representative should conduct annual audits of the QMS to ensure ongoing compliance with ISO 13485 and local regulations. This may include internal audits or third-party audits by accredited bodies.

• Updated Certificates: Ensure that any new ISO 13485 certifications or changes to your GMP status are communicated to BPOM.

• Inspection Readiness: BPOM may conduct periodic inspections of the manufacturing facility or local distributor to verify that the GMP and other standards continue to be met. Be prepared for inspections at any time and ensure that all documentation is current and readily available.

6. Post-Registration Inspections

BPOM may perform periodic inspections on the manufacturing facility or local distribution chain to ensure ongoing compliance with regulatory standards. This could include:

• GMP Inspections: BPOM will inspect the manufacturing process to ensure compliance with Good Manufacturing Practices (GMP) and ISO 13485 standards.

• Facility Audits: BPOM may audit the premises of the authorized representative or importers to confirm that devices are being distributed in accordance with regulatory requirements.

• Surveillance Inspections: BPOM may carry out surveillance inspections as part of the ongoing post-market surveillance activities to confirm that the product continues to meet safety and quality standards in the Indonesian market.

7. Ongoing Communication with BPOM

Maintaining open communication with BPOM is essential for staying compliant. After your device is registered, you should:

• Respond promptly to BPOM requests: If BPOM requires additional information or clarification regarding the device or its safety, respond as quickly as possible to avoid delays.

• Stay updated on regulatory changes: BPOM may periodically update its regulations, guidelines, or technical requirements. Make sure to stay informed of any changes in the regulatory environment and ensure that your device continues to comply with new rules.

• Maintain records for audit: Ensure that all records, including clinical data, adverse event reports, post-market surveillance data, and compliance audits, are up to date and readily available for inspection or review by BPOM.

8. Renewal and Extended Approvals

• Renewing Clinical Data: If the device requires any clinical trials or new clinical data, make sure this information is submitted as part of the 5-year renewal process.

• Temporary Approvals: If the device was approved with temporary conditions (such as a provisional clinical trial or limited marketing authorization), ensure that you meet all requirements for full approval before the provisional period expires.

9. Distribution and Marketing Updates

Once the device is on the market, keep track of:

• Distribution Licenses: The local distributor and importers must maintain valid licenses and ensure they comply with any updates or additional regulatory requirements.

• Marketing Updates: If the device is promoted through advertising, ensure that the marketing materials comply with BPOM’s advertising regulations for medical devices.

Conclusion

After registering your Class 3 medical device with BPOM, it is important to stay proactive in managing periodic updates, renewals, and compliance requirements. This includes regular fee payments, post-market surveillance, device inspections, handling of changes to the device, and continuous communication with BPOM. Ensuring your device remains compliant with Indonesian regulations over its lifecycle is critical for maintaining market access and avoiding disruptions.

If you need additional details on any of the specific processes or have other questions, feel free to reach out!

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