Post-Registration Considerations for Class A Medical Devices with Indonesia MOH

After obtaining Class A medical device registration with Indonesia's Ministry of Health (MOH), there are several important actions and considerations to ensure continued compliance with regulations, successful market entry, and smooth distribution of your product in Indonesia. Here's a detailed guide to what you should note:

1. Issuance of Izin Edar (Distribution License)

• What it is: The Izin Edar is the official distribution license issued by the Ministry of Health (MOH) upon successful registration of the device.

  • This license grants permission to distribute the medical device within Indonesia.
  • It is valid for five years, but you must ensure timely renewal before expiration.

• Action: Safeguard the Izin Edar certificate and ensure it is kept updated.

2. Post-Market Surveillance and Reporting

• Requirement: Even after obtaining registration, you are required to comply with post-market surveillance requirements. The Indonesian MOH mandates monitoring the safety and performance of medical devices once they are available on the market.

• What to do:

  • Establish a system for tracking complaints or adverse events related to the device.
  • Report any serious incidents or adverse events to the MOH through BPOM or the local authorities.
  • Market surveillance inspections may be carried out by the MOH or BPOM to ensure that products continue to comply with safety standards.

• Regulatory Basis: Regulation No. 62/2017 and other relevant MOH guidelines require manufacturers to monitor and report on post-market performance.

3. Ongoing Compliance with Indonesian Regulations

• Maintain Documentation: Keep your technical files and compliance documents up to date, especially if there are changes to the device or manufacturing process.

  • Any modifications to the device (e.g., new materials, changes to design) may require re-submission for approval.
  • Ensure that labels and IFUs remain compliant with Indonesian language requirements and regulatory standards.

• Quality Management System (QMS): Maintain the ISO 13485:2016 QMS certification, which is essential for continuing to meet regulatory requirements and ensuring quality control in the manufacturing process.

• Labeling Compliance: Keep the labeling, including product information, batch/serial numbers, and expiration dates, up to date and in compliance with Indonesian regulations (e.g., in Bahasa Indonesia).

4. Device Advertising and Promotion

• Advertising Guidelines: The promotion and advertising of medical devices in Indonesia are strictly regulated. You must ensure that any marketing or advertising materials comply with MOH regulations to avoid misleading claims or non-compliance.
  • Advertising of medical devices requires approval by the Indonesian Ministry of Health, and all claims made in advertisements must be supported by evidence.
• What to do:
  • Ensure that all advertisements, promotional materials, and claims made about the device adhere to the truth and do not exaggerate its capabilities.

5. Product Importation and Distribution

• Importation: If your company is importing the medical device into Indonesia, you must ensure compliance with customs and import regulations. A local distributor or authorized representative must be designated if you are not located in Indonesia.

• Distribution:

  • Ensure your device is distributed in compliance with local regulations.
  • Regularly check with BPOM and the MOH for updates on import/export procedures, taxes, and tariffs that may impact the cost or logistics of bringing the product into Indonesia.

6. Renewal of Registration (Izin Edar)

• Five-Year Validity: The Izin Edar is valid for five years, after which it must be renewed to continue distributing the device in Indonesia.

• Action:

  • Monitor expiration dates of the Izin Edar and begin the renewal process at least six months prior to expiration.
  • The renewal process will require you to provide updated documentation and possibly submit new test results or updates if the device or its manufacturing process has changed.
  • Ensure you have a local representative to assist with the renewal process if needed.

7. Local Representative and Authorized Importer

• Requirement: If you are an international manufacturer, Indonesia requires you to have a local representative (e.g., a local distributor or authorized importer) to manage your registration, distribution, and post-market surveillance obligations.

• Action:

  • Ensure that your local representative is properly registered with BPOM and that they are fully informed about the regulatory requirements for maintaining compliance.
  • Keep communication lines open with the local representative to address any regulatory or safety concerns quickly.

8. Continued Compliance with International Standards

• ISO 13485 and Other Certifications: Maintaining international standards, such as ISO 13485 for quality management and ISO 14971 for risk management, is critical for ongoing registration and market access.

• Action:

  • Ensure you continue to meet international regulatory standards, and undergo regular audits to verify compliance.
  • Re-certify your quality management system, risk management, and other necessary certifications as required by Indonesia and international regulations.

9. Changes in Legislation and Regulatory Updates

• Keep Up-to-Date: Indonesian regulations related to medical devices may change over time, and the MOH may issue new guidelines, updates, or amendments to existing regulations.
  • Regularly check for updates on the BPOM and MOH websites.
• Action:
  • Stay informed about any regulatory updates or changes to the classification, labeling, or post-market surveillance requirements for medical devices in Indonesia.
  • Implement necessary changes or updates to ensure compliance with any new laws or guidelines.

10. Inspections and Audits

• MOH and BPOM Inspections: The MOH may conduct inspections of your manufacturing process, quality control procedures, or marketing materials. Additionally, BPOM may carry out audits or checks to ensure ongoing compliance with medical device regulations.

• Action:

  • Be prepared for possible inspections and audits. Ensure that your records, labeling, and technical files are always up-to-date and accessible for review by the authorities.

Summary of Key Post-Registration Actions:

1. Maintain the Izin Edar and renew it before it expires.
2. Conduct post-market surveillance to monitor device safety and performance.
3. Ensure ongoing compliance with Indonesian regulations (quality control, labeling, QMS, etc.).
4. Comply with advertising regulations and avoid misleading claims.
5. Monitor and comply with importation/distribution requirements.
6. Prepare for inspections and audits by MOH or BPOM.
7. Stay updated on changes to medical device regulations in Indonesia.
8. Ensure that your local representative continues to fulfill their obligations in managing your device's registration and distribution.

By following these post-registration steps, you will ensure that your Class A medical device remains compliant with Indonesian regulations, allowing for successful market access and distribution. If you need further clarification or help with a specific post-registration requirement, feel free to reach out!

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