Once Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM is approved, there are several key considerations to ensure compliance with Indonesian regulations and maintain market access. Below are the important actions and ongoing responsibilities after the registration is approved:

1. Compliance with Post-Market Surveillance Requirements

After approval, the local authorized representative (AR) and the manufacturer are required to ensure that the medical device continues to meet safety and performance standards once it is on the market.

• Post-Market Surveillance: Continuously monitor the device’s performance in the market to detect any potential safety or effectiveness issues. This includes tracking user feedback, complaints, and any adverse events.
• Adverse Event Reporting: If any adverse events or incidents related to the device occur, they must be reported to BPOM. This includes issues such as device malfunctions, user injuries, or any other incidents that compromise the device’s safety or effectiveness.
• Recall Procedures: If safety concerns arise, the manufacturer or authorized representative must have a procedure in place for device recalls. BPOM must be informed promptly if a recall is necessary.

2. Labeling and Packaging Compliance

The medical device's labeling and packaging must continue to comply with Indonesian regulations even after approval.

• Labeling in Bahasa Indonesia: Ensure that the device remains labeled in Bahasa Indonesia, as required by BPOM. The label must include:
  • Product name, manufacturer details, and intended use.
  • Warnings, precautions, and instructions for use.
  • Expiry date and storage instructions, where applicable.
• Packaging: Continue to meet packaging standards (e.g., sterile packaging for sterile devices). Ensure that packaging is tamper-evident, protects the device, and meets safety standards.

3. Registration Renewal

The registration certificate issued by BPOM for Class I devices is typically valid for 5 years from the date of approval.

• Renewal Application: Before the expiration of the registration, manufacturers must submit a renewal application to BPOM to extend the validity of the registration. BPOM may request updated documents, such as safety reports, post-market surveillance data, or new certifications.
• Monitoring of Device Changes: If any significant changes occur in the design, manufacturing process, or intended use of the device, these may require a new registration application or an amendment to the existing registration.

4. Maintain Documentation and Record Keeping

The local authorized representative (AR) should maintain a comprehensive documentation system for the medical device in Indonesia.

• Device Registration Files: Keep a record of all documents related to the device’s registration, including:
  • Registration certificate issued by BPOM.
  • Compliance documents, such as ISO certifications, CFS (Certificate of Free Sale), and test reports.
  • Post-market surveillance reports, including any adverse event reports and actions taken.
• Batch/Production Records: Keep records of manufacturing, including batch numbers, production dates, and any quality control documentation.

5. Marketing and Distribution Compliance

• Distributor and Importer Compliance: Ensure that the device is only sold through approved distributors and importers who have the necessary licenses issued by BPOM.
• Distribution Channels: Ensure that the device is distributed through legal channels in Indonesia. This means working only with authorized importers or distributors who are registered with BPOM.

6. Ongoing Compliance with Regulatory Updates

Indonesia’s regulatory landscape can evolve over time, so it is essential to keep updated with any changes to medical device regulations.

• BPOM Regulatory Updates: Monitor BPOM communications, official websites, and newsletters for any updates or changes in regulatory requirements, including any changes in classification rules, new documentation requirements, or safety standards.
• Regulatory Affairs Team: Ensure that your regulatory affairs team or local representative is actively monitoring Indonesian medical device regulations to stay compliant with the latest requirements.

7. Importation and Customs Compliance

• Import Documentation: Ensure that all devices imported into Indonesia are accompanied by the necessary import documentation, including:
  • Registration certificate from BPOM.
  • Invoice, shipping documents, and customs declarations.
  • Import licenses and tax clearance if required.
• Customs Regulations: Work with a licensed customs broker to ensure that your medical device meets Indonesia's importation rules and regulations. Proper clearance will ensure the devices are delivered without unnecessary delays.

8. Conducting Audits and Inspections

• BPOM or other regulatory bodies in Indonesia may perform random inspections of medical devices on the market, especially if there are safety concerns.
• Be prepared for audits of your manufacturing process or your local authorized representative's (AR) facilities in Indonesia to verify compliance with GMP and other regulatory standards.
• Ensure that the local representative or distributor can provide accurate records during such audits.

9. Preparing for New Product Releases or Changes

If you introduce new versions of your Class I medical device or if there are any modifications to the device’s design or intended use, these changes may require an amendment to the existing registration.

• New Models/Versions: If there are significant changes to the device (e.g., new materials, additional features, or different intended uses), you may need to submit a new registration application or update the existing registration.
• Manufacturing Changes: If there are changes in the manufacturing process, facilities, or equipment used, you must inform BPOM and, in some cases, update the registration.

10. Exporting the Device

If you plan to export the registered Class I medical device from Indonesia to other markets, ensure that you comply with export regulations.

• You may need to provide documentation such as the Certificate of Free Sale (CFS) or regulatory compliance documents required by the importing country.
• Keep track of any changes in regulations in export markets that could affect your device's compliance.

Summary of Key Considerations After Registration Approval:

1. Post-Market Surveillance: Monitor device performance and report adverse events or safety concerns to BPOM.
2. Labeling and Packaging Compliance: Ensure labeling remains compliant with Bahasa Indonesia requirements and packaging meets safety standards.
3. Renewal Application: Submit for renewal before the 5-year expiration and update documents as necessary.
4. Documentation and Record Keeping: Maintain all relevant records, including registration certificates, test reports, and post-market surveillance data.
5. Marketing and Distribution Compliance: Ensure devices are distributed via authorized channels and that distributors/importers are compliant with regulations.
6. Regulatory Updates: Stay informed about changes in Indonesian regulations and ensure ongoing compliance.
7. Importation and Customs Compliance: Comply with customs and import regulations for devices sold in Indonesia.
8. Audits and Inspections: Be prepared for regulatory audits and inspections of your facilities or your AR’s facilities.
9. Changes to the Device: Report and seek approval for any changes to the device, manufacturing process, or intended use.
10. Export Compliance: If exporting, comply with the requirements of other countries and maintain necessary documentation.

By staying proactive in these areas, manufacturers can maintain compliance, ensure patient safety, and continue to sell their devices in the Indonesian market without disruption.

Contact Us：

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