After applying for Class C medical device registration with the Indonesian Ministry of Health (MOH) and BPOM, there are several key regulations and requirements that must be followed to ensure compliance and ensure that the device remains legally marketable in Indonesia. These regulations cover aspects such as labeling, post-market surveillance, reporting, and renewing the registration.

Here are the critical regulations and requirements you must adhere to:

1. Compliance with BPOM’s Regulations and Guidelines

• Regulation No. 27 of 2017 (or the latest regulation) governs the registration of medical devices in Indonesia. Once you submit your application, ensure that your device continues to meet the requirements outlined in these regulations throughout the approval and post-market phases.
• BPOM Approval: Once the registration is approved, BPOM will issue a Marketing Authorization (often referred to as the NOM), allowing you to sell and distribute the medical device in Indonesia. Compliance with BPOM’s regulations is mandatory for maintaining this authorization.

2. Labeling and Packaging Requirements

• Language: All labels, instructions for use (IFU), and packaging must be in Bahasa Indonesia.
• Required Information: The labels must include:
  • Device name and model.
  • Manufacturer’s name and address.
  • Serial or batch numbers.
  • Intended use of the device.
  • Warnings, precautions, and contraindications.
  • Expiration date (if applicable) or shelf life.
  • Storage conditions.
  • Regulatory status (e.g., BPOM approval).
• Conformance to BPOM Guidelines: Ensure that the labels and packaging conform to BPOM’s detailed guidelines on medical device labeling (e.g., Regulation No. 84 of 2018 for labeling requirements for medical devices).

3. Marketing and Promotion Compliance

• Advertising Restrictions: Your promotional materials, advertisements, and marketing campaigns must comply with BPOM’s requirements for medical device promotion. Advertising must be truthful and non-misleading.
  • Claims regarding the efficacy or safety of the device must be supported by valid clinical or performance data.
  • BPOM prohibits the use of misleading claims or any unsupported statements that could influence the public’s perception of the device.
• No Direct Consumer Advertising (for certain medical devices): Certain high-risk medical devices may have restrictions on direct-to-consumer advertising.

4. Post-Market Surveillance (PMS) and Adverse Event Reporting

• Ongoing Monitoring: You must monitor the device’s performance in the market to ensure it remains safe and effective. BPOM requires a Post-Market Surveillance (PMS) plan to ensure that you track and manage the safety of the device once it’s on the market.
• Adverse Event Reporting: Any serious adverse events or device malfunctions must be reported to BPOM. You are required to notify BPOM within a specified period after becoming aware of the event.
  • Serious incidents, such as life-threatening problems or injuries caused by the device, must be reported immediately (usually within 10 days).
  • Incident Report: Submit a detailed report about the incident, including the nature of the issue, any corrective actions taken, and any risk mitigation steps.
• Product Recalls: If there is a significant safety issue, BPOM may require you to initiate a product recall. You must cooperate fully with BPOM and follow their guidelines for managing recalls.
  • A recall plan should be established and ready to be implemented if needed, including notifying consumers, health institutions, and BPOM.

5. Good Manufacturing Practices (GMP) and Quality Assurance

• Continued GMP Compliance: Your manufacturing facility must continue to adhere to Good Manufacturing Practices (GMP) as required by BPOM. If your facility is located overseas, BPOM may conduct inspections to verify compliance.
• ISO Certifications: Continue to ensure that the manufacturing process meets applicable ISO standards (e.g., ISO 13485 for Quality Management, ISO 14971 for Risk Management).
• Audit and Inspection: BPOM may conduct routine inspections of your production facility or your authorized representative in Indonesia to ensure that the medical device continues to meet regulatory standards.

6. Monitoring and Reporting of Clinical Data

• Ongoing Clinical Data Collection: For Class C medical devices, ongoing clinical data or performance monitoring may be required. If any new evidence arises indicating the device’s performance has changed (positive or negative), you must update BPOM and the Indonesian market.
• Clinical Trials (if necessary): If BPOM requests, provide updated clinical trial data or additional evidence to support the safety and efficacy of your device.
• Periodic Reports: Periodic clinical safety and performance reports may be required to demonstrate ongoing device safety and effectiveness.

7. Regulatory Compliance for Changes to the Device

• Substantial Changes: Any changes to the device (e.g., design, materials, manufacturing process, indications) that could affect its safety or performance must be communicated to BPOM. You must submit a notification or a new registration application for approval if the change is deemed significant.
• Minor Changes: For minor modifications, BPOM may allow an update to the existing registration. However, this is dependent on the scope and impact of the change.
• Product Variant Changes: If you introduce new variants of the device (e.g., different sizes, models, configurations), these may need separate registrations or notifications to BPOM.

8. Importation and Distribution Regulations

• Authorized Importer: Your authorized distributor or importer in Indonesia must be BPOM-registered. The importer is responsible for ensuring that the device complies with customs and import regulations.
• Market Distribution Compliance: Ensure that your device’s distribution network complies with all local laws and regulations. BPOM may require your distribution channels to be audited periodically to verify compliance with applicable standards.

9. Product Registration Renewal

• Renewal Process: Medical device registration in Indonesia is typically valid for 5 years. Prior to expiration, you must apply for renewal with BPOM.
  • The renewal application requires updated documents, including the device’s current safety and performance data and GMP certification.
• Re-registration: If significant changes have been made to the device, a new registration may be required, in addition to the renewal.

10. Regulatory Fees and Payments

• Fee Structure: After the registration is approved, you will be required to pay annual regulatory fees and maintenance fees for your device. BPOM will notify you of these fees, and failure to pay them can lead to the suspension of your registration.
• Timely Payment: Ensure that you stay on top of any fees related to maintaining the device’s market authorization in Indonesia.

11. Record Keeping and Documentation

• Maintain accurate and up-to-date records of all regulatory documentation, including:
  • Device design and specifications.
  • Quality control and manufacturing processes.
  • Clinical trials and safety data.
  • Correspondence with BPOM and other authorities.
• Ensure that these documents are easily accessible in case of BPOM inspections or audits.

Key Regulatory Requirements to Follow Post-Approval:

1. Ensure ongoing compliance with BPOM regulations, including adherence to labeling, packaging, and advertising guidelines.
2. Maintain a Post-Market Surveillance (PMS) plan and monitor adverse events.
3. Report any serious incidents or device malfunctions to BPOM within the required timeframes.
4. Continue to comply with Good Manufacturing Practices (GMP) and ISO certifications.
5. Notify BPOM of any changes to the device or manufacturing process.
6. Prepare for periodic inspections and audits by BPOM to verify ongoing compliance.
7. Stay informed about regulatory updates from BPOM and renew the device registration before it expires.
8. Maintain accurate documentation for potential audits and regulatory reviews.

By following these requirements and staying on top of regulatory compliance, you can ensure the continued success of your Class C medical device in the Indonesian market. Let me know if you need more specific guidance or have any additional questions!

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