Preparations for Class A Medical Device Registration with Indonesia MOH

Before applying for Class A medical device registration with Indonesia’s Ministry of Health (MOH), thorough preparation is necessary to ensure that the registration process is smooth and compliant with all local regulations. Below are the key steps and preparations you should make:

1. Confirm Classification of the Device

• Class A Classification: Verify that your device qualifies as a Class A medical device under Indonesian regulations. Class A devices are low-risk devices, and it’s essential to confirm this classification to ensure you follow the correct regulatory path.
  • The classification is typically determined based on the intended use, duration of contact with the body, and invasiveness of the device.
  • Class A devices generally include non-invasive, low-risk devices like bandages, surgical masks, and simple diagnostic devices.

2. Choose an Authorized Local Representative or Distributor

• Requirement for Foreign Manufacturers: If you are an international manufacturer, you must have a local representative or authorized distributor in Indonesia. This representative will handle the regulatory and compliance processes on your behalf.
  • The representative will assist with submission of documentation, liaison with the Indonesian Ministry of Health (MOH), and post-market surveillance obligations.
  • Action: Identify and establish a partnership with a reliable local distributor or authorized representative that is registered with BPOM (Indonesian Food and Drug Authority) and familiar with local regulations.

3. Prepare the Technical Documentation and Regulatory Compliance Documents

Ensure that you have all the required technical documentation and that it complies with both Indonesian regulations and international standards. Key documents typically include:

• Device Description: A detailed description of the device, including its intended use, design, and materials used.
• Risk Management Documentation: Documentation that follows ISO 14971, including risk analysis and risk control measures.
• Safety and Performance Data: Test reports showing the safety, effectiveness, and quality of the device. This may include:
  • Biocompatibility testing (for devices in contact with the body).
  • Electrical safety reports (for electrical devices).
  • Sterility assurance (if applicable).
  • Other relevant safety tests.
• ISO Certifications: If applicable, ensure you have ISO 13485 certification for quality management systems, as it will be required for registration.
• Clinical Evidence: For some devices, especially those involving new technologies or indications, clinical data may be required.
• Labeling and IFU: Ensure that the labeling and Instructions for Use (IFU) are prepared in Bahasa Indonesia. The labeling must include device name, manufacturer details, storage conditions, expiration date, warnings, and other regulatory information.

4. Review and Align with Indonesian Standards (SNI)

• Compliance with SNI (Standar Nasional Indonesia): Make sure your device complies with any relevant Indonesian National Standards (SNI) that apply to medical devices. These standards can relate to labeling, safety, and testing requirements.
  • For instance, SNI 01-7687-2013 relates to the labeling of medical devices in Indonesia.
  • You may also need to comply with SNI ISO 13485 for quality management systems, which is essential for ensuring ongoing compliance with Indonesian regulations.

5. Organize Your Quality Management System (QMS)

• ISO 13485 Certification: If you don’t already have it, obtaining ISO 13485:2016 certification is highly recommended. This standard sets out the criteria for a quality management system (QMS) specific to the medical device industry.
  • Action: Ensure your QMS meets the required international standards, which is critical for ensuring the safety and quality of your medical device.
  • A valid ISO 13485 certification will support your registration application and demonstrate your commitment to quality and regulatory compliance.

6. Ensure Adequate Risk Management

• ISO 14971: This international standard provides a framework for identifying and managing risks associated with medical devices. For Class A devices, a formal risk analysis is still required to identify potential hazards and take appropriate mitigation measures.
  • Action: Prepare a Risk Management File that includes:
    • Risk analysis.
    • Control measures.
    • Residual risks.

7. Packaging and Labeling Compliance

• Prepare Packaging Designs: Ensure that your product packaging meets the MOH's labeling requirements, which include product name, manufacturer information, batch number, expiration date, and storage conditions.
  • Translation to Bahasa Indonesia: All labels and Instructions for Use (IFU) must be provided in Bahasa Indonesia.
  • Symbols: Use the proper graphical symbols as per ISO 15223-1 for medical device labeling.

8. Develop a Plan for Post-Market Surveillance (PMS)

• Post-Market Obligations: In Indonesia, manufacturers are required to have a post-market surveillance system in place to track the safety and performance of the device after it reaches the market.
  • Action: Develop a post-market surveillance plan and ensure that you are prepared to report any adverse events or incidents related to the device.

9. Understand the Regulatory Fees and Timeline

• Fee Structure: Familiarize yourself with the registration fees and regulatory costs associated with submitting a Class A device registration to the MOH. While Class A devices are low-risk and the registration process is generally simpler, you will still need to budget for application fees, possible local representative costs, and any testing or certification fees.

• Timeline: Be prepared for the registration process to take several months, as the MOH will review your application and documentation. Factor in time for any necessary revisions or additional documentation requests.

10. Prepare for Importation and Distribution

• Importation License: If you are importing the device into Indonesia, you may also need to obtain an importation license from BPOM. This process will require specific documentation, such as proof of registration, customs clearance, and other importation requirements.

• Distribution Plan: Ensure that your local distributor or representative is ready to handle the device's distribution within Indonesia in compliance with local regulations.

Summary of Key Preparations:

1. Confirm the classification of your device as Class A under Indonesian regulations.
2. Identify and appoint a local authorized representative or distributor in Indonesia.
3. Prepare all technical documentation, including safety data, risk management files, and testing reports.
4. Ensure compliance with Indonesian National Standards (SNI).
5. Obtain ISO 13485 certification for your quality management system (QMS).
6. Ensure your labeling and packaging meet Indonesian requirements, with translations into Bahasa Indonesia.
7. Develop a post-market surveillance plan for tracking device performance post-registration.
8. Understand registration fees and timelines.
9. Ensure you are prepared for the importation process if applicable.
10. Plan for distribution through a reliable local distributor in Indonesia.

By ensuring that these steps are properly prepared, you can facilitate a smoother registration process and ensure your device complies with all Indonesian regulatory requirements. Let me know if you need assistance with any of these steps or more details!

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