To apply for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) through Badan Pengawas Obat dan Makanan (BPOM), several conditions must be met. These conditions are designed to ensure that the medical device meets safety, performance, and quality standards before it can be marketed in Indonesia. Below is a list of the key conditions that need to be fulfilled:

1. Class 3 Classification Criteria

Class 3 medical devices are high-risk devices that are intended to be used in critical medical applications. They are subject to strict scrutiny due to their potential impact on patient health. The classification is based on:

• Intended Use: The device is intended to support or sustain life, prevent impairment of health, or mitigate potential risk of injury or illness.
• Invasiveness: Class 3 devices typically have a high degree of invasiveness (e.g., implants, long-term surgical devices) or are in contact with vital organs.
• Clinical Data Requirement: Class 3 devices require robust clinical data to demonstrate their safety and efficacy.

If your device falls under Class 3 (as per BPOM’s classification system), you can proceed with the registration process. This includes the need for clinical trial data or extensive post-market data (for devices already marketed elsewhere).

2. Appointment of Authorized Representative (for Foreign Manufacturers)

• Foreign manufacturers must appoint a local authorized representative in Indonesia. This representative will act as the contact point for BPOM and handle the entire registration process.
• Local manufacturers can apply directly without the need for an authorized representative.

3. Compliance with International Standards

• The manufacturing processes and quality management systems of the medical device must comply with international standards:
  • ISO 13485: The device must be manufactured in compliance with the Quality Management System (QMS) for medical devices, such as ISO 13485.
  • Good Manufacturing Practices (GMP): The manufacturing facility must comply with GMP standards, which ensure that the device is produced in a controlled environment to minimize the risk of contamination and defects.

4. Clinical Data and Risk Management

For Class 3 medical devices, clinical data and risk management documentation are mandatory:

• Clinical Trials: You must provide clinical trial data that demonstrates the safety and efficacy of the device. This is especially important for new devices or modifications to existing ones.
  • If the device is already marketed in another country with adequate clinical data, you can submit post-market surveillance data or real-world evidence as a substitute.
  • Clinical trials should be conducted in compliance with Good Clinical Practice (GCP).
• Risk Management Documentation: You must submit a risk analysis in accordance with ISO 14971, identifying potential risks associated with the device and how they are mitigated.
  • This includes conducting biocompatibility testing (if applicable) and ensuring the device does not pose undue risk to patients.

5. Compliance with Regulatory Standards

• Performance Testing: Depending on the type of device, you must provide test reports to demonstrate compliance with relevant performance standards. For example:
  • IEC 60601 for electrical safety (for electrical medical devices).
  • ISO 10993 for biocompatibility testing (if the device has direct contact with the human body).
  • EMC (Electromagnetic Compatibility) testing for devices that use electrical or wireless communication.

6. Labeling and Instructions for Use

• All product labeling and Instructions for Use (IFU) must be in Bahasa Indonesia (the official language of Indonesia). The labeling must include:
  • Device name.
  • Manufacturer details and authorized representative details (if applicable).
  • Indications for use and any contraindications or warnings.
  • Storage conditions and expiration date (if applicable).
  • Device classification.
  • Contact information for customer support or emergencies.
• The IFU must include detailed, step-by-step instructions for using the device safely, as well as troubleshooting or maintenance information if applicable.

7. Certificate of Free Sale (CFS)

• CFS is required for foreign manufacturers, confirming that the device is legally marketed in its home country and complies with local health regulations.
• The CFS must be issued by the health authority of the manufacturer’s home country and should be valid and up-to-date.

8. Valid Documentation of Compliance

• ISO Certification: You will need to provide ISO 13485 certification (for the Quality Management System) and other relevant certificates (e.g., CE mark, FDA approval) depending on where the device is marketed.
• Post-market Surveillance Data: If your device is already marketed in another country, post-market data (e.g., safety reports, adverse event reports) should be submitted to show the device’s performance in real-world settings.

9. Good Manufacturing Practice (GMP) Compliance

• The manufacturing facility must comply with GMP regulations, which ensure that the device is produced in a safe and controlled manner. BPOM may request evidence of GMP compliance, and in some cases, BPOM may conduct an on-site inspection of the manufacturing facility.

10. Environmental and Ethical Compliance

• Environmental Compliance: Some devices, especially those that involve chemical substances or disposal, must meet environmental regulations (e.g., waste disposal, toxicological considerations).
• Ethical Compliance: If the device is subject to clinical trials, you must adhere to ethical standards, including patient consent and ethical trial designs.

11. Financial Responsibility

• You will need to pay applicable registration fees to BPOM. The fees may vary depending on the class and complexity of the device, and they need to be paid at the time of submission.

Conclusion: Conditions for Applying for Class 3 Medical Device Registration in Indonesia

To apply for Class 3 medical device registration in Indonesia, the device must:

1. Be classified as Class 3 based on its risk and intended use.
2. Have an authorized representative in Indonesia (for foreign manufacturers).
3. Comply with international standards such as ISO 13485 and GMP.
4. Provide robust clinical data, including clinical trials or post-market data.
5. Submit a risk management file (compliant with ISO 14971).
6. Include performance test reports (for electrical, biocompatibility, or other relevant tests).
7. Provide labeling and Instructions for Use (IFU) in Bahasa Indonesia.
8. Submit a Certificate of Free Sale (CFS) (for foreign manufacturers).
9. Ensure compliance with GMP at the manufacturing facility.

By ensuring compliance with these conditions, you can submit a complete and robust application for Class 3 medical device registration with BPOM.

Let me know if you need further assistance with any part of the process!

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