After applying for Class 3 medical device MOH registration in Indonesia, manufacturers and authorized representatives must continue to follow several important regulations and requirements to ensure compliance throughout the review and approval process and post-registration period. These regulations aim to guarantee the safety, quality, and efficacy of medical devices, as well as the proper handling and distribution of medical devices once they are marketed in Indonesia.

Here’s an overview of the key regulations and requirements to follow after applying for Class 3 medical device MOH registration in Indonesia:

1. Compliance with BPOM Regulations

The Indonesian Ministry of Health (MOH), through the Badan Pengawas Obat dan Makanan (BPOM), is responsible for regulating medical devices in Indonesia. After submitting your application, the following regulations and guidelines must be adhered to:

• Regulation No. 27/2017: This regulation outlines the procedures and requirements for registering medical devices in Indonesia, including Class 3 devices. It provides the technical guidelines for the registration process, including documentation submission and safety standards.

• Regulation No. 72/2016: This regulation governs the general requirements for medical devices in Indonesia, including labeling, testing, clinical trials, and post-market surveillance.

• Decree No. 159/2016: This decree specifies the classifications of medical devices and the corresponding registration requirements for each class. Class 3 devices, being high-risk devices, have the most stringent documentation and regulatory requirements.

2. Submission of Complete and Accurate Documentation

After applying, ensure that you have submitted all the required documentation in full and are prepared to respond promptly to any BPOM requests for additional information. These documents include:

• Device Description and Technical Data: Complete details about the device's intended use, design, and materials.
• Clinical Data: Clinical trial results or other safety and efficacy data (if applicable).
• ISO 13485 Certificate: Ensure your Quality Management System (QMS) certificate is valid and properly aligned with BPOM requirements.
• Risk Management Documentation: Compliance with ISO 14971 for risk management.
• Safety and Performance Test Reports: As per relevant standards like IEC 60601, IEC 61000, and ISO 10993.
• GMP Certification: Provide proof that the manufacturer complies with Good Manufacturing Practices.

3. Responding to BPOM Inquiries

BPOM may request additional documentation or clarification during the evaluation process. You must be prepared to:

• Provide requested information: BPOM may ask for more detailed explanations or supporting data for clinical trials, performance testing, or manufacturing practices.
• Clarify labeling, technical details, or manufacturing processes: If BPOM identifies any discrepancies or unclear information in your application, be prepared to respond promptly and accurately.
• Submit amendments or updates: If there are any updates or changes to the product's safety profile, manufacturing process, or clinical data, you must submit these to BPOM for review.

4. Compliance with Labeling and Packaging Regulations

Once BPOM receives and processes your application, it will review your device labeling and packaging for compliance with Indonesian regulations. You must ensure that your device's labels and packaging meet the following standards:

• Labeling in Bahasa Indonesia: All labels must include essential information in Bahasa Indonesia, such as:

  • Device name
  • Manufacturer's name and address
  • Intended use and indications for use
  • Precautions and warnings
  • Instructions for use (IFU) in Bahasa Indonesia
  • Expiry date (if applicable)
  • Batch or lot number

• Regulatory Information: The registration number issued by BPOM must be included on the label once the device is approved for marketing.

• Compliance with ISO Standards: Ensure that the labels and packaging comply with the ISO 15223-1 (symbols for medical device labels) and ISO 20417 (general requirements for labels and instructions for use).

5. Importation and Distribution Requirements

During the review period, you must ensure compliance with Indonesia’s importation and distribution regulations:

• Import License: The importer must hold a valid import license issued by BPOM. Only licensed importers can legally bring medical devices into Indonesia.

• Distribution License: The distributor responsible for selling the medical device in Indonesia must also hold a distribution license issued by BPOM.

• Authorized Representative: If you are a foreign manufacturer, ensure that your appointed local authorized representative (such as a distributor or importer) remains compliant with Indonesian regulations.

• Post-Market Surveillance Plan: As part of the distribution process, you must maintain a post-market surveillance program to monitor the device's performance in the field. Any issues must be reported to BPOM promptly.

6. Clinical Trial and Post-Market Surveillance

While your application is under review, BPOM may request additional data or updates regarding the device's clinical trials or post-market surveillance. The following points are essential:

• Clinical Trial Registration: If the device requires clinical trials to demonstrate safety and efficacy, ensure that these trials are conducted in compliance with Indonesian Good Clinical Practice (GCP) standards. Provide the relevant documentation to BPOM as needed.

• Adverse Event Reporting: Once the device is marketed, you must have a system in place for reporting adverse events or device malfunctions to BPOM. Reports should be made within 15 days for serious incidents and 30 days for other issues.

• Field Safety Corrective Actions (FSCA): If safety concerns arise after the device is marketed, you must have a process in place for corrective actions, such as recalls or safety warnings.

7. BPOM Inspection

BPOM may conduct an inspection of your manufacturing site (if it’s outside Indonesia) or the local importer/distributor to ensure compliance with GMP and quality standards. Be prepared for:

• Inspection of Manufacturing Facilities: BPOM may inspect the manufacturing facility to verify that GMP is being followed. Ensure that all documentation related to GMP compliance is available for inspection.

• Importation and Distribution Site Inspections: BPOM may inspect the facilities of the authorized representative, importers, and distributors to confirm that all licensing requirements are met and the medical device is handled appropriately.

8. Ongoing Regulatory Compliance and Monitoring

Once your device is registered and approved, compliance is an ongoing responsibility:

• Annual Fees: BPOM may charge annual fees for the maintenance of the device’s registration. Ensure that fees are paid promptly to avoid any disruption in the device’s availability in the market.

• Monitoring of Compliance: Continuously ensure compliance with Indonesian regulations, including any updates to BPOM’s guidelines, standards, or requirements.

• Renewal of Registration: The registration is valid for 5 years, so you must prepare for renewal applications well before the expiry date. This may involve submitting updated clinical data, risk management documentation, and safety reports.

• Changes to Device: If there are any significant changes to the device, such as design modifications or updates to indications, you must submit a supplementary application to BPOM for review and approval.

9. Communication with BPOM

Ensure continuous communication with BPOM during the registration process. Promptly respond to any requests for clarification, additional information, or documentation.

Conclusion

After submitting your application for Class 3 medical device registration with BPOM in Indonesia, ensure ongoing compliance with all relevant regulations. This includes submitting accurate and complete documentation, adhering to labeling and post-market surveillance requirements, and maintaining effective communication with BPOM throughout the review and approval process. Additionally, once the device is marketed, be proactive in handling adverse events, ensuring quality, and staying compliant with Indonesian medical device laws.

If you need further assistance with any of these post-application steps or additional clarifications, feel free to ask!

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