For regular updates and maintenance of a Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), it is essential to adhere to certain standards and processes. Regular updates ensure that the device continues to meet regulatory requirements and remains compliant with any changes in local laws, standards, and safety requirements. Below is a detailed guide on the standards and processes for maintaining your Class II medical device registration in Indonesia.

1. Registration Renewal

In Indonesia, Class II medical device registrations are typically valid for 5 years from the date of approval. To maintain the validity of your registration, you must apply for renewal before the expiration date. The renewal process typically involves:

a. Renewal Application Submission

• Timeline:
  • It is recommended to initiate the renewal process at least 6 months before the registration expires to avoid disruptions in your product availability.
• Required Documents:
  • Submit updated documentation, including:
    • Current product technical documentation.
    • New or updated certificates such as GMP certificates, ISO certifications (e.g., ISO 13485), and Certificate of Free Sale (CFS) if applicable.
    • Adverse event reports or clinical trial data (if required).
    • Post-market surveillance reports.
    • Updated labeling or IFU (Instructions for Use) if there have been any changes.
• BPOM Evaluation:
  • BPOM will review the renewal application and assess whether the device is still compliant with the latest regulations and standards. They may require additional information or conduct an inspection if there are significant changes in the device or its manufacturing processes.

b. Updated Fees

• The renewal fee must be paid according to BPOM's prescribed schedule. Ensure that the fee is submitted as part of the renewal application.

2. Notifications for Changes in Product Information

If there are any changes to the product’s characteristics, design, manufacturing processes, labeling, or intended use, BPOM must be notified promptly. The following are common updates that require BPOM notification or re-evaluation:

a. Changes in Manufacturer or Authorized Representative

• Manufacturer Changes:
  • If there is a change in the manufacturer or the location of manufacturing, BPOM must be notified. This may require an inspection of the new facility or updated GMP certifications.
• Authorized Representative Changes:
  • If there is a change in the authorized representative in Indonesia, you must submit the necessary documentation (e.g., power of attorney, letter of authorization) to BPOM.

b. Modifications to the Device

• Design Changes:
  • Any significant changes in the design or materials of the device (e.g., change in biocompatibility, performance characteristics, or intended use) must be reported to BPOM. BPOM may request additional testing or clinical data.
• Labeling Changes:
  • Any modifications to the labeling or IFU (Instructions for Use), such as updates to warnings, indications, or contraindications, should be submitted for approval. If the changes impact the safety or intended use of the device, BPOM may require additional documentation or testing.

c. Changes in Indications or Intended Use

• Indications for Use:
  • If the intended use or indications of the device are modified (e.g., expanding or limiting its clinical application), you must inform BPOM. These changes may necessitate a re-assessment of the device’s registration.

d. Clinical Data and Performance Updates

• Clinical Studies:
  • If new clinical trials or studies are conducted post-market, the results must be submitted to BPOM if the data impacts the safety, efficacy, or regulatory classification of the device.
• Post-market Surveillance Data:
  • Regular post-market surveillance reports (e.g., adverse events, product complaints, performance issues) must be submitted to BPOM as required. Any significant new findings regarding the device’s performance may require a change in the registration or label.

3. Post-Market Surveillance and Adverse Event Reporting

As part of maintaining the registration, ongoing post-market surveillance (PMS) is mandatory. Manufacturers must monitor the safety and efficacy of their devices after they are marketed and make necessary updates based on this information. This includes:

a. Adverse Event Reporting

• Adverse Event Submission:
  • Manufacturers must report adverse events (e.g., device malfunction, injury, or death) to BPOM in a timely manner. The general rule is to report serious adverse events within 15 days and less severe incidents within 30 days.
  • If the event has a significant impact on patient safety, BPOM may require further investigation, product recalls, or updates to the device's labeling or instructions.

b. Corrective and Preventive Actions (CAPA)

• Based on post-market feedback, manufacturers may be required to take corrective actions (e.g., product recall, design changes) or preventive actions to mitigate future risks.
• Recall Notification:
  • If a device is found to be defective or harmful, BPOM may order a recall. In such cases, you must promptly notify BPOM and implement a plan to remove the affected devices from the market.

c. Periodic Safety Reports (PSUR)

• For certain high-risk devices or when there are significant post-market concerns, BPOM may require periodic safety update reports (PSUR). These reports summarize the safety data, including adverse events, complaints, and any corrective actions taken.

4. Compliance with GMP (Good Manufacturing Practice)

Ongoing GMP compliance is crucial for maintaining the registration. BPOM may conduct periodic inspections of your manufacturing facility, whether domestic or overseas, to ensure adherence to Good Manufacturing Practices.

a. Inspection Requirements

• Routine GMP Inspections:
  • BPOM may conduct routine inspections to verify that the manufacturing processes comply with GMP guidelines. These inspections can include reviewing records, processes, and product testing results.
• Inspection for Changes:
  • If there have been significant changes in the manufacturing process (e.g., new equipment or suppliers), BPOM may conduct an inspection to ensure continued compliance with regulatory standards.

b. Maintain GMP Certification

• Renew GMP Certification:
  • If your manufacturing facility’s GMP certification is due to expire or needs to be updated, ensure that the renewal process is completed in time and submitted to BPOM.

5. Labeling and Promotional Material Updates

If there are any changes in the product’s labeling or advertising materials, ensure that these are compliant with Indonesian regulations.

a. Changes to Labeling

• Submit updated labeling to BPOM if changes have been made to the packaging or instructions for use (e.g., updated warnings, symbols, or expiration dates).
• Ensure that the updated labels and IFU are in Bahasa Indonesia and comply with BPOM’s labeling requirements.

b. Advertising and Promotional Materials

• Any changes in the advertising or promotional materials for the medical device need BPOM approval, particularly if the claims made in advertisements are related to the device’s performance or safety.

6. Regulatory Updates and Compliance

Regulatory requirements may change over time, and BPOM periodically updates guidelines, standards, or laws governing medical devices.

a. Keep Abreast of Regulatory Changes

• Stay Updated:
  • Monitor BPOM’s updates, including any changes in laws or guidelines that may affect your device. Regulations around device classification, labeling, clinical requirements, or testing standards may evolve.
• Proactive Updates:
  • If new regulations are introduced, proactively update your registration to comply with the revised requirements. This might include new testing standards, new post-market surveillance requirements, or changes in labeling guidelines.

b. Report Regulatory Changes to BPOM

• Notify BPOM of any changes that might affect the safety, performance, or classification of your device. This can include changes in the regulatory environment, product specifications, or new clinical data.

7. Re-Evaluation for New Devices or Expansions

If your device undergoes significant modifications or is intended for use in new clinical indications or markets, BPOM may require a re-evaluation of your product's registration.

a. New Indications or Use Cases

• Submit additional documentation or testing results if you plan to expand the device’s indications for use or target patient population. New clinical studies may be required to support the updated use case.

b. New Versions or Variants of the Device

• If you introduce a new version or variant of the device (e.g., different sizes, colors, or configurations), BPOM may require a re-registration or modification to the original registration.

Summary of Regular Updates and Maintenance Requirements for Class II Medical Device Registration in Indonesia

1. Registration Renewal: Initiate the renewal process 6 months before expiration, submitting updated documents and fees.
2. Product Change Notifications: Notify BPOM of any modifications, including changes in manufacturing, labeling, indications, or clinical data.
3. Post-Market Surveillance: Implement ongoing monitoring, adverse

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