After submitting your application for D-class medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (the National Agency of Drug and Food Control), there are several ongoing regulations and requirements that must be followed to ensure compliance. These include post-submission activities, maintaining registration, and adhering to quality, safety, and marketing standards.

1. Submission Confirmation and Review Process

• Confirmation of Application: After submission, BPOM will issue an acknowledgment receipt of your registration application. This confirms that your application has been received and is under review.
• Completeness Check: BPOM will check whether the submitted documents are complete and comply with Indonesian regulations. If any documents are missing or require clarification, BPOM will request you to submit additional information.

2. Post-Submission Document Updates (if necessary)

• Document Corrections: If BPOM finds any issues with the submission (e.g., missing or incorrect information), you will need to promptly correct the documents and resubmit them. This is important to avoid delays in processing.
• Technical Evaluation: BPOM will assess the technical data (performance, safety, and testing results) submitted for the device. This evaluation may involve a technical committee from BPOM reviewing the device's safety and compliance with relevant standards.

3. Labeling Compliance

• Ensure Proper Labeling: The device labeling must comply with Indonesian regulations. BPOM may review your product labels during the review process to ensure they meet local requirements.
  • All labels must be in Indonesian or have an official translation. They should include essential information such as the product name, manufacturer details, batch/serial number, and expiration date (if applicable).
  • Instructions for use (IFU) must also be in Indonesian and include safety warnings, intended use, and maintenance instructions.
• Approval of Labels: BPOM may request revisions or additional information regarding the labeling to ensure it complies with the law before issuing approval.

4. Ensure Compliance with Indonesian Standards and Quality Assurance

• Compliance with Local Standards: During the review, BPOM will check that your device complies with Indonesian safety and performance standards. This includes adherence to any relevant international standards (e.g., ISO 13485, IEC 60601, ISO 10993 for biocompatibility, etc.).
• Quality Management System (QMS): If your company holds a QMS certification such as ISO 13485, BPOM may require the relevant documentation to confirm that your device is manufactured following internationally recognized quality standards. However, this is generally more critical for higher-risk devices, but having a QMS in place is beneficial.

5. Post-Market Surveillance (PMS)

• Post-Market Monitoring: Once the device is registered and approved, your company is required to implement an ongoing post-market surveillance system. This is a regulatory requirement to monitor the safety and performance of the device once it enters the Indonesian market.
  • Adverse Event Reporting: If any adverse events (e.g., malfunctions, injuries, or complaints) occur after the device is sold, these must be reported to BPOM promptly.
  • Corrective Actions: If a device defect is identified, your company may need to initiate a recall or provide corrective measures (e.g., repairs or modifications to the device).
  • Periodic Reporting: Some devices require periodic safety and performance reports, which must be submitted to BPOM.

6. Notification of Changes and Amendments

• Product Changes: If there are any changes to your device (e.g., design, components, labeling), you must notify BPOM and submit an amendment to the registration. This includes changes in manufacturing processes, intended use, or product specifications.
• Manufacturing Site Changes: If your manufacturing site changes (e.g., you move production to a different facility), this must also be reported to BPOM, and new documentation may be required.
• Updating the Registration: If your device undergoes significant modifications, you may need to update your registration or submit a new application, depending on the nature of the changes.

7. Importation and Distribution Compliance

• Importation Process: If your D-class medical device is being imported into Indonesia, you must comply with the Indonesian importation laws. Devices must be imported by a registered local distributor or authorized representative.
• Import Documentation: Ensure that all importation documents (e.g., customs clearance, import licenses) reflect the registered device and that the customs authorities have the proper documentation from BPOM.
• Distribution Compliance: Devices should only be distributed through registered and compliant distribution channels. Local distributors must maintain proper documentation of the device’s registration and comply with post-market surveillance requirements.

8. Registration Renewal

• Renewal of Registration: The registration for D-class medical devices is typically valid for 5 years. Prior to the expiration of the registration, you must apply for renewal by submitting updated documents, including a current Certificate of Free Sale (CFS) and any necessary performance or safety data.
  • Early Renewal: It is recommended to apply for renewal several months before the expiration to avoid disruptions in the product's market availability.
  • Reevaluation: BPOM may require reevaluation of the device’s performance and safety during the renewal process, particularly if there have been changes in regulations or new standards.

9. Monitoring of Adverse Events and Complaints

• Adverse Event Reporting: If your device is involved in an adverse event (e.g., injury, failure, safety issue), you must report this to BPOM within a specified time frame (usually within 10 days of the occurrence).
  • Device Recall: If BPOM determines that a device is unsafe, they may issue a recall order. You must have a plan in place for recalling products from the market, repairing or replacing faulty devices, and notifying customers.
• Complaint Handling: Address any complaints or safety concerns raised by users in a timely manner. BPOM may require records of these complaints and your responses during inspections.

10. Advertising and Marketing Compliance

• Marketing Restrictions: Your marketing materials and advertisements must comply with Indonesian regulations. Medical device advertisements are closely regulated, and claims made about the device must be supported by evidence. Misleading claims are prohibited.
• Promotional Materials: Ensure that all promotional content (brochures, websites, etc.) aligns with the claims made in your registration documents and that it doesn’t exaggerate the device’s effectiveness or safety beyond what is documented.

11. Regulatory Inspections

• Routine Inspections: BPOM may conduct inspections of your manufacturing facilities or those of your local distributor as part of their compliance monitoring activities. These inspections ensure that the device continues to meet regulatory requirements throughout its lifecycle.
• Document Verification: BPOM may ask for copies of documents related to the device’s performance, manufacturing process, and post-market surveillance reports during these inspections.

Summary of Ongoing Requirements After D-Class Registration:

1. Maintain Proper Documentation: Ensure all product, labeling, and performance data is current and accurate. Notify BPOM of any changes to the device or its manufacturing process.
2. Comply with Post-Market Surveillance (PMS): Implement systems to monitor device safety, report adverse events, and take corrective actions if necessary.
3. Submit Periodic Reports: Provide safety and performance data to BPOM as required.
4. Renew Registration: Apply for registration renewal 5 years before the expiration date.
5. Ensure Compliance in Importation and Distribution: Follow all regulations for importing, distributing, and marketing your device in Indonesia.
6. Adhere to Advertising and Marketing Regulations: Ensure that any promotional material complies with local laws.
7. Prepare for Inspections: Be ready for BPOM inspections or audits to ensure ongoing compliance with Indonesian medical device regulations.

By adhering to these post-registration requirements, your device will remain compliant with Indonesian regulations, ensuring that it can continue to be marketed and sold without issues.