To apply for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) through Badan Pengawas Obat dan Makanan (BPOM), you need to submit a comprehensive registration dossier. The required documents will depend on the device type and intended use but generally include both technical and regulatory documents, clinical data, and compliance certificates.

Here’s a detailed list of required documents and guidelines for preparing your application for BPOM’s evaluation:

Required Documents for Class 3 Medical Device Registration in Indonesia

1. Registration Application Form

• BPOM Application Form: Complete the official registration application form. This can be done online via the BPOM e-Registry system or on paper, depending on the submission method.

2. Device Description

• Device Information: Provide a detailed description of the medical device, including:
  • Product name and model number.
  • Intended use (e.g., diagnostic, therapeutic).
  • Mechanism of action (how the device works).
  • Specifications: Technical details like dimensions, material composition, and any special features.
  • Classification: Clearly state the classification (Class 3) according to BPOM’s classification guidelines.

3. Manufacturer and Authorized Representative Information

• Manufacturer's details: The name and contact details of the manufacturer.
• Authorized Representative (for foreign manufacturers): Provide the contact details of the authorized representative in Indonesia. The authorized representative will handle the registration process on behalf of the foreign manufacturer.

4. Manufacturing and Quality Control Information

• Manufacturing Process Description: Outline the design and manufacturing process of the device, including:
  • Production methods.
  • Raw materials used.
  • Testing and quality control measures.
• ISO 13485 Certification: A valid ISO 13485 certification, which shows that the manufacturer has implemented a Quality Management System (QMS) that complies with international standards for medical devices.
• Good Manufacturing Practice (GMP): Evidence that the manufacturer complies with GMP regulations. This may be a certification or declaration from the manufacturer.

5. Clinical Data (Essential for Class 3 Devices)

• Clinical Trial Data: Provide results from clinical trials that demonstrate the device's safety and efficacy. This may include:
  • Human clinical trial data (if the device is newly developed or has significant modifications).
  • Post-market surveillance data (for devices already marketed in other countries).
  • Scientific literature supporting the clinical use of the device.
• Risk Management File: A risk analysis document following ISO 14971, which evaluates potential hazards and describes risk mitigation strategies. This file should include:
  • Hazard analysis.
  • Risk assessment (probability and severity).
  • Risk control measures implemented.

6. Certificates and Approvals

• Certificate of Free Sale (CFS): A document issued by the health authority in the country of origin, confirming that the device is legally sold and marketed in that country. This document is especially important for foreign manufacturers.
• Declaration of Conformity (DoC): A statement by the manufacturer declaring that the device complies with relevant standards and regulations. This may include:
  • CE marking (if the device is marketed in the EU).
  • FDA approval (if the device is approved by the U.S. FDA).
• ISO Certificates:
  • ISO 13485 (Quality Management System).
  • ISO 14971 (Risk management for medical devices).
  • Any other relevant ISO certifications based on the device's type.

7. Labeling and Instructions for Use

• Product Labeling: Provide a copy of the product labeling, which must be in Bahasa Indonesia (the official language of Indonesia). The labeling must include:
  • Device name, model, and serial number.
  • Manufacturer details.
  • Intended use, warnings, contraindications, and precautions.
  • Storage conditions, expiration date (if applicable).
  • Country of origin.
• Instructions for Use (IFU): Detailed instructions on how to properly use the device, including:
  • Step-by-step procedures.
  • Safety information.
  • Maintenance and care instructions.
  • Contraindications.
• If the device involves specialized instructions or training, include any necessary guidance.

8. Performance Test Reports

• For devices such as electrical medical devices or implantables, provide test reports that demonstrate compliance with relevant performance standards (e.g., IEC 60601 for electrical safety, ISO 10993 for biocompatibility).
• Include testing results for:
  • Electrical safety (if applicable).
  • Electromagnetic compatibility (EMC).
  • Biocompatibility testing results (if applicable, especially for devices that have direct contact with human tissue).

9. Packaging and Storage Information

• Packaging Details: Describe the device’s packaging, including:
  • Packaging materials and design.
  • Sterilization methods (if applicable).
  • Shelf life information (if applicable).
• Storage Instructions: Guidelines on how to store the device properly (e.g., temperature, humidity).

How to Prepare the Application Documents:

1. Organize and Review All Documents:

   • Start by ensuring all the required documents are accurately prepared and up-to-date. For instance, ensure that clinical trial data is current and valid, and that certifications like ISO 13485 and CFS are valid.
   • Check that all documents are correctly translated into Bahasa Indonesia if necessary (especially labeling and IFU).

2. Use BPOM's e-Registry System:

   • If applying electronically, create an account on BPOM’s e-Registry system. The system allows manufacturers or authorized representatives to submit documents digitally.
   • Upload the complete dossier, ensuring that the files are properly organized and labeled for easy reference.

3. Ensure Completeness and Compliance:

   • Double-check that all required documents are included, especially clinical data, certifications, and testing reports, as these are often the most scrutinized components of the application.
   • Ensure the labeling is compliant with BPOM’s guidelines and that it meets Indonesian requirements.

4. Consult with Local Regulatory Experts:

   • If you’re not familiar with Indonesian regulations or the BPOM submission process, consider working with a local regulatory consultant or authorized representative who is experienced in medical device registration in Indonesia. They can help ensure compliance and streamline the process.

5. Prepare for Additional Requests:

   • BPOM may request additional documentation or clarification during the evaluation process, especially for high-risk devices like Class 3 medical devices. Be prepared to respond promptly.

Important Notes:

• Clinical Data for Class 3 Devices: Class 3 devices are considered high-risk and typically require strong clinical evidence to demonstrate their safety and efficacy. Clinical trial data and post-market data from other countries will be particularly important in this case.

• Risk Management: BPOM places significant importance on risk management for Class 3 devices. Your submission should include comprehensive documentation showing how potential risks are mitigated and managed throughout the product lifecycle.

• Authorized Representative: If you're a foreign manufacturer, ensure that your Indonesian authorized representative is prepared to handle all interactions with BPOM. They should be familiar with the regulatory requirements and the submission process.

• Language Requirement: Ensure that all documentation such as the product labeling and Instructions for Use (IFU) is translated into Bahasa Indonesia. Non-compliant or incorrect translations can delay the registration process.

• Post-Market Surveillance: After registration, you must adhere to post-market surveillance requirements. This includes reporting adverse events, conducting product recalls if necessary, and updating BPOM with any new clinical or safety data.

Conclusion:

To successfully apply for Class 3 medical device registration in Indonesia, you need to prepare a comprehensive registration dossier that includes a range of documents, from technical and clinical data to quality certifications and labeling. By ensuring the accuracy and completeness of your submission, and working with a local authorized representative if needed, you can help ensure a smooth registration process with BPOM.

Let me know if you need help with any specific part of the application!

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