Before applying for Class 3 medical device MOH registration in Indonesia, several critical preparation steps must be completed to ensure the process goes smoothly and meets the regulatory requirements set by the Indonesian Ministry of Health (MOH), specifically Badan Pengawas Obat dan Makanan (BPOM). Here is a breakdown of the key preparation work:

1. Understanding the Regulatory Framework

• Familiarize with BPOM regulations: Thoroughly understand BPOM’s regulations for medical device registration, particularly Regulation No. 27/2017 and Decree No. 72/2016. These outline the specific requirements for Class 3 medical devices, including documentation, safety and performance evidence, and registration procedures.
• Know the classification criteria: Ensure the device qualifies as Class 3, which typically involves high-risk devices requiring extensive safety and clinical data.

2. Appoint a Local Authorized Representative (if applicable)

If the device manufacturer is located outside of Indonesia, appoint an authorized representative in Indonesia. This representative will handle the registration process and manage communication with BPOM.

• The authorized representative must be a legal entity in Indonesia, such as a distributor or importer with the proper licenses.
• This representative will be responsible for submitting the application, providing ongoing regulatory support, and complying with BPOM’s requirements.

3. Gather Required Documentation and Information

The registration process requires submitting comprehensive documentation to prove the safety, efficacy, and quality of the Class 3 medical device. Prepare the following key documents:

a. Basic Documentation

• Device Description: Detailed technical specifications, including the intended use, classification, design, materials, and manufacturing process of the device.
• Manufacturer Information: Information about the manufacturer, including company name, address, and manufacturing license.
• Authorized Representative Agreement: A document confirming the appointment of the local authorized representative, if applicable.

b. Quality Management System (QMS) Documentation

Class 3 devices must comply with ISO 13485 (Quality Management System for Medical Devices). Ensure the following is in place:

• ISO 13485 Certification: Provide a copy of the valid ISO 13485 certification for the manufacturing facility.
• Audit Reports: Include any recent audit reports from regulatory bodies or third-party auditors to demonstrate compliance with quality standards.

c. Risk Management and Clinical Data

• ISO 14971 Risk Management: Document how risk management has been applied throughout the device’s lifecycle. Include risk assessment reports, mitigation strategies, and post-market surveillance plans.
• Clinical Evaluation: For Class 3 devices, clinical trial data or clinical evaluation reports may be required to demonstrate safety and efficacy. Prepare a clinical investigation report or literature-based clinical evidence showing that the device performs as intended without adverse effects.

d. Safety and Performance Testing Reports

• IEC 60601 (Electrical Safety) and IEC 61000 (Electromagnetic Compatibility) certifications, if applicable, for electrical devices.
• ISO 10993 biocompatibility testing results, particularly if the device is in direct contact with the human body (e.g., implants or surgical devices).
• Sterility Testing: If the device is sterile, provide evidence that the sterilization process complies with ISO 20857.
• Performance Testing: Provide any performance test reports that demonstrate the device’s functionality, reliability, and safety under real-world conditions.

e. Labeling and Packaging Information

Ensure that the device labeling and instructions for use (IFU) comply with BPOM’s requirements. This includes:

• Labels in Bahasa Indonesia: All labels and packaging must be in Bahasa Indonesia and include required information such as the device name, manufacturer details, intended use, storage instructions, and warnings.
• IFU in Bahasa Indonesia: Instructions for use must be clear, complete, and in the local language, detailing the device’s application, proper usage, precautions, and contraindications.

f. Post-Market Surveillance Plan

BPOM requires that manufacturers demonstrate a plan for ongoing post-market surveillance and adverse event reporting. Prepare the following:

• Adverse Event Reporting System: A system for reporting any post-market safety issues or product defects.
• Field Safety Corrective Actions (FSCA): A plan to manage potential product recalls or corrective actions in the event of safety concerns.

4. Ensure GMP Compliance

• Good Manufacturing Practice (GMP): Ensure the manufacturing facility complies with GMP standards for medical devices. BPOM may conduct inspections to verify GMP compliance before registration.
• GMP Certification: Obtain a GMP certificate from the relevant authority or provide evidence of GMP compliance through audit reports or third-party inspections.

5. Prepare for BPOM Fees

• BPOM charges various registration and review fees during the application process. Ensure you understand these costs and budget accordingly.

6. Establish an Import and Distribution Plan

For devices that are imported into Indonesia, the importer and distributor must be licensed by BPOM:

• Import License: Ensure the importer holds a valid import license for medical devices issued by BPOM.
• Distribution License: If necessary, the distributor must have a valid medical device distribution license from BPOM.

7. Prepare for a Site Inspection (if applicable)

BPOM may conduct an inspection of the manufacturing facility (especially for high-risk Class 3 devices) to verify compliance with quality standards, including GMP. Ensure that:

• The manufacturing facility is ready for inspection.
• Necessary documents, such as audit reports and certifications, are available for review during the inspection.

8. Confirm Clinical and Safety Data Compliance

Ensure that all clinical and safety data provided is up to date and compliant with BPOM guidelines for Class 3 devices. This includes:

• Clinical Trial Data: If the device has been involved in clinical trials, ensure all relevant clinical data is available, including ethical approvals and results.
• Regulatory Approvals in Other Markets: If the device has already been approved in other regions (e.g., CE mark, FDA, TGA), include this information as part of the submission to demonstrate the device’s global safety and efficacy track record.

9. Understand the Registration Timeline

Familiarize yourself with the estimated processing time for Class 3 medical device registration in Indonesia. The process typically takes several months, depending on the complexity of the device and completeness of the application.

• Plan for Delays: The process might take longer if BPOM requires additional documents or clarification. Ensure you allocate sufficient time for potential delays.

10. Prepare for Regulatory Communication

Prepare for ongoing communication with BPOM throughout the registration process. Be ready to:

• Respond to inquiries or requests for additional information: BPOM may request further details or clarification about your device.
• Follow up on progress: Stay in touch with BPOM to track the status of your application.

Conclusion

Preparing for Class 3 medical device MOH registration in Indonesia requires meticulous planning and thorough documentation. Ensure that all technical, clinical, safety, and regulatory compliance documents are ready, and appoint a local authorized representative if needed. Ensure adherence to ISO 13485 and GMP standards, and be prepared for a site inspection and post-market obligations. Proper preparation can significantly streamline the registration process and help avoid delays.

If you have any specific questions or need assistance with any part of the preparation process, feel free to ask!

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