Once your Class C medical device registration is approved by the Indonesian Ministry of Health (MOH) and BPOM, there are several key aspects to note in order to ensure ongoing compliance with Indonesian regulations. Below are the important considerations after receiving approval:

1. Obtain Marketing Authorization (NOM)

• After the registration is approved, BPOM will issue the Marketing Authorization (NOM) for your Class C medical device. This authorization allows you to legally market and distribute the device in Indonesia.
• Ensure that the NOM is prominently displayed on the device labeling and accompanying documents as required by BPOM.

2. Labeling and Packaging Requirements

• Labeling Compliance: Ensure that your device’s labels and packaging meet the BPOM requirements, including:
  • Labeling in Bahasa Indonesia: All labels, instructions for use (IFU), and other information should be in the Indonesian language.
  • Clear Device Information: Ensure that the label includes required information such as the device's name, model, serial number, intended use, manufacturer information, and expiry date (if applicable).
  • Compliance with BPOM's Regulations: BPOM provides specific guidelines for medical device labeling. Verify that your labeling meets these requirements (e.g., warnings, contraindications, storage conditions).

3. Distribution and Importation

• Authorized Importer: If you are a foreign manufacturer, your device must be imported by an authorized importer or distributor in Indonesia. Ensure that your importer has BPOM approval to distribute medical devices.
• Distribution Network: Make sure your distribution network is compliant with local regulations. This includes verifying that all distributors and resellers in Indonesia are properly registered and authorized to distribute medical devices.

4. Post-Market Surveillance (PMS)

• Post-Market Monitoring: After approval, you must continuously monitor the performance of your medical device in the market. BPOM requires a Post-Market Surveillance (PMS) plan to ensure that the device remains safe and effective once distributed.
• Adverse Event Reporting: Establish and maintain a system for adverse event reporting. If your device causes harm or adverse effects, you are required to report these incidents to BPOM and take appropriate action, such as recalls or safety warnings.
• Periodic Safety Updates: Provide BPOM with periodic safety reports or updates as required, which could include data on device performance, safety, and any new clinical information.

5. Quality Control and GMP Compliance

• Ongoing GMP Compliance: Ensure continuous compliance with Good Manufacturing Practice (GMP) throughout the manufacturing and distribution processes. BPOM may conduct inspections of your manufacturing facilities (if you are the manufacturer or have a direct connection to the production process) to verify compliance.
• Maintain ISO Certifications: If your device is subject to ISO certification (e.g., ISO 13485), ensure that the quality management system (QMS) is maintained and updated regularly to meet international and local standards.
• Routine Audits: BPOM may require periodic audits of your manufacturing facilities or quality management systems to ensure that ongoing compliance is maintained.

6. Product Recalls (If Necessary)

• Recall Procedures: Be prepared to execute a product recall if any safety concerns arise with your device. This could be triggered by:
  • A serious adverse event or risk associated with the device.
  • If the device does not meet the safety or performance specifications.
• Ensure that your post-market surveillance and PMS plan include protocols for initiating and managing product recalls.
• Notification to BPOM: If a recall occurs, you must inform BPOM immediately and follow their procedures for notifying the market and affected parties.

7. Regulatory Updates and Compliance

• Regulatory Changes: Stay informed about changes in local regulations and BPOM guidelines. Indonesia's medical device regulations may evolve, and non-compliance could affect your product’s market authorization.
• Ongoing Documentation: Ensure that your regulatory documentation remains up-to-date, especially in terms of:
  • Certifications: Such as GMP certificates, ISO certifications, etc.
  • Clinical Data: If there are any updates to the clinical data or performance testing, report them to BPOM.
• Maintain a Relationship with BPOM: You should maintain a good working relationship with BPOM in case of any regulatory inquiries or updates.

8. Renewal of Registration

• Registration Renewal: Although Class C medical device registrations are typically valid for 5 years, you need to ensure that the device registration is renewed before it expires.
  • The renewal process may require submitting updated documents, confirming continued compliance with GMP, and providing any new clinical data or safety reports.
• Continuing Compliance: Ensure that your device continues to comply with any new or updated SNI, ISO standards, and BPOM guidelines, which may change over time.

9. Advertising and Promotion

• Advertising Compliance: When promoting your medical device in Indonesia, ensure that all advertising and marketing materials comply with BPOM’s regulations. This includes ensuring that claims made about the device’s benefits, safety, and performance are accurate and substantiated by evidence.
• Marketing Restrictions: Avoid marketing practices that are not permitted by BPOM, such as making unsubstantiated claims or misleading statements about the device.

10. Communication with Indonesian Regulatory Authorities

• Reporting Issues: If any issues arise post-registration (e.g., quality issues, safety concerns, etc.), communicate promptly with BPOM and follow the required steps.
• Communication with Local Authorities: Keep the local regulatory authorities updated on any changes in your manufacturing processes, device specifications, or distribution channels.

Summary of Key Considerations After Class C Registration Approval in Indonesia:

1. Obtain and display the Marketing Authorization (NOM).
2. Ensure labeling and packaging meet BPOM’s requirements (including Bahasa Indonesia).
3. Ensure authorized importation and distribution in Indonesia.
4. Establish and implement an effective Post-Market Surveillance (PMS) plan.
5. Maintain GMP compliance and ongoing quality control.
6. Be prepared for product recalls and ensure adverse event reporting.
7. Stay updated on regulatory changes and ensure compliance with evolving standards.
8. Renew the registration before expiration and ensure continuous compliance.
9. Ensure advertising and promotions comply with BPOM regulations.
10. Keep an open line of communication with BPOM and local authorities.

By actively managing the ongoing regulatory responsibilities and maintaining a focus on safety and quality, you can ensure the continued success of your Class C medical device in the Indonesian market.

Let me know if you need further clarification or additional assistance!

Contact Us：

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