After the approval of Class 3 medical device registration by the Indonesian Ministry of Health (MOH) through Badan Pengawas Obat dan Makanan (BPOM), several key responsibilities and compliance requirements need to be followed to ensure the continued validity of the device's registration and its compliance with local regulations. Here’s what should be noted after the approval:

1. Issuance of Registration Certificate

Once BPOM approves the registration, a registration certificate will be issued. This certificate is the official document confirming that the medical device has met all regulatory requirements and is authorized for sale in Indonesia.

Key Considerations:

• Validity of the Registration: The registration is typically valid for 5 years. The manufacturer or authorized representative should plan for timely renewal.
• Product Identification Number: This is assigned to the registered product and must be used for all related commercial and legal purposes in Indonesia.

2. Post-Market Surveillance

After approval, post-market surveillance is critical to ensure the continued safety and performance of the device once it is in use. BPOM requires manufacturers and distributors to monitor the device’s performance in the market, report any adverse events, and address any safety concerns.

Key Responsibilities:

• Adverse Event Reporting: Any adverse events or product defects that occur after the device is marketed in Indonesia must be reported to BPOM within a specified time frame (usually 15 days for serious events).
• Field Safety Corrective Actions (FSCA): If issues arise that require corrective actions, such as product recalls or design changes, these must be communicated to BPOM.
• Periodic Safety Updates: Some Class 3 devices may require periodic safety update reports to BPOM, especially if the device is part of a high-risk category or has been linked to significant post-market safety issues.

3. Labeling Requirements

Once approved, all medical device labeling must comply with Indonesian regulations and the product registration details. The Instructions for Use (IFU), packaging, and labels must reflect the correct registration details, including the product name, manufacturer, indications for use, and other relevant information in Bahasa Indonesia.

Key Considerations:

• Changes to Labeling: Any changes to labeling or the product’s indications, contraindications, or instructions must be submitted to BPOM for approval before they can be implemented.
• Annual License Fees: BPOM may require the payment of annual license fees for continued registration. Ensure that these fees are paid on time to avoid any interruptions in the ability to sell the device in Indonesia.

4. Renewal of Registration

The registration for Class 3 medical devices is valid for 5 years. Before the expiration of the registration, you must submit a renewal application with updated documentation, including clinical data, post-market surveillance reports, and proof of continued compliance with applicable standards.

Renewal Process:

• Submit a Renewal Application: At least 6 months before the expiration of the registration, submit a renewal application to BPOM.
• Updated Documentation: Ensure that updated documentation (clinical, performance, and safety data) is submitted for the renewal process.
• GMP and ISO Certification Updates: Provide updated GMP, ISO 13485, and other relevant certificates as part of the renewal process.

5. Import and Distribution Requirements

After registration, you must adhere to the importation and distribution regulations set by BPOM for medical devices. This includes working with an authorized importer and distributor for the device in Indonesia.

Key Considerations:

• Authorized Representative: If the manufacturer is based outside Indonesia, they must appoint a local authorized representative to manage the regulatory and commercial aspects of the device in Indonesia.
• Import License: The importer must have a valid import license from BPOM. Devices must only be sold through licensed distributors and authorized importers.
• Customs and Clearance: The device will need to go through customs clearance upon importation into Indonesia. The importer must ensure all customs paperwork and documentation are properly submitted and aligned with the registered product’s details.

6. Compliance with Advertising and Promotion Regulations

In Indonesia, advertising and promotion of medical devices are strictly regulated by BPOM. Ensure that any marketing or promotional activities for the Class 3 device are in line with the legal requirements.

Key Considerations:

• Medical Device Advertising: Advertising of medical devices in Indonesia must not make false or misleading claims. All claims about the device must be substantiated by scientific evidence and approved by BPOM.
• Product Promotion: Promotional materials such as brochures, websites, and advertisements must comply with the approved labeling and regulatory guidelines.

7. Ongoing Compliance with International Standards

Even after registration, ongoing compliance with international standards such as ISO 13485, ISO 14971, and others is required for maintaining the device’s safety, quality, and performance in the market.

Key Responsibilities:

• Regular Audits and Inspections: BPOM may conduct inspections of manufacturing facilities or importers to ensure continuous compliance with GMP and other regulatory requirements.
• Updated Certifications: Keep all quality certifications (ISO, GMP, CE, etc.) up-to-date and provide BPOM with updated copies as requested.

8. Post-Market Data Collection and Reporting

Collecting post-market data and using it to improve the device’s safety profile is essential. This includes tracking device performance, gathering user feedback, and staying compliant with post-market surveillance requirements.

Key Responsibilities:

• Complaint Handling System: Implement a system to handle customer complaints, feedback, and any product-related issues.
• Corrective Actions: If problems with the device arise, you may need to implement corrective actions such as product recalls or modifications to the device.

9. Keep BPOM Updated on Changes

You must notify BPOM about any significant changes to the device’s design, production process, clinical data, or any safety concerns that could affect the device’s regulatory status. This includes:

• Changes to manufacturing sites.
• Updates to clinical trial data or post-market safety findings.
• Modifications to the device that could impact its safety, performance, or indications for use.

10. Ongoing Communication with BPOM

Maintain ongoing communication with BPOM and ensure that you are prepared for any inspections or audits that may occur throughout the device’s lifecycle in Indonesia. BPOM may request periodic updates on the device’s market performance and compliance with regulatory requirements.

Conclusion

Once a Class 3 medical device is registered in Indonesia, manufacturers and authorized representatives must ensure continuous compliance with post-market surveillance, renewal, labeling, safety reporting, and any regulatory updates required by BPOM. Timely renewal of the registration, proper reporting of adverse events, and adherence to local regulatory and quality standards are crucial for maintaining the legal sale and distribution of the device in Indonesia.

If you need further assistance with any specific post-registration requirements, feel free to ask!