To apply for Class II medical device registration with the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) in Indonesia, the applicant must meet specific conditions and requirements set forth by BPOM. These conditions ensure that the device complies with safety, efficacy, and quality standards.

Here are the main conditions that must be met:

1. Appointment of a Local Authorized Representative (AR) or Importer

• Foreign Manufacturers: If the medical device is manufactured outside of Indonesia, you must appoint a local authorized representative (AR) or importer. This entity will act as the liaison between BPOM and the manufacturer and will be responsible for submitting the registration application, managing documentation, and handling communication with BPOM.
• Indonesian Manufacturers: Local manufacturers can apply directly but still need to meet all regulatory requirements.

2. Device Classification Confirmation

• The device must be correctly classified as Class II under Indonesian medical device regulations.
• Class II devices are considered to be of moderate risk and typically include diagnostic equipment, surgical tools, patient monitoring devices, and certain in-vitro diagnostic devices.
• Ensure that the classification is accurate, as BPOM may request documentation or a justification for the classification.

3. Compliance with Regulatory Standards

• The medical device must comply with Indonesian medical device regulations and standards, which align with international standards such as:
  • ISO 13485 (Quality Management System for Medical Devices)
  • ISO 14971 (Risk Management for Medical Devices)
• Manufacturing Compliance: The manufacturer must adhere to Good Manufacturing Practices (GMP), and BPOM may request proof of GMP certification.
• Risk Management: The device should meet risk management standards, with appropriate documentation, especially for Class II devices.

4. Device Safety and Efficacy Data

• BPOM requires evidence that the device is safe and effective for its intended use. This includes:
  • Clinical Evaluation Report (CER): This report assesses the clinical data or studies supporting the device’s performance and safety. For Class II devices, BPOM may require clinical data, especially if the device is novel or has limited market history.
  • Risk Management Documentation: A risk management report (per ISO 14971) should be provided, demonstrating that the device has been assessed for risks and mitigated accordingly.

5. Proper Documentation and Certification

• The following documentation is required to be submitted with the registration application:
  1. Certificate of Free Sale (CFS): A certificate from the country of origin confirming that the device is legally sold and approved for use.
  2. ISO 13485 Certification: Proof that the manufacturer complies with the international quality management standard for medical devices.
  3. Good Manufacturing Practices (GMP) Certificate: This is necessary to demonstrate that the manufacturing facility adheres to internationally recognized manufacturing standards.
  4. Clinical Evaluation Report (if applicable).
  5. Product Labeling: Labels and instructions for use (IFU) in Bahasa Indonesia. This is critical to ensure the device’s proper use and understanding by Indonesian users.

6. Compliance with BPOM's Registration Process

• Electronic Registration: The application must be submitted via BPOM's online e-registration system or manually if required. All required documents must be uploaded electronically.
• Registration Fees: The appropriate registration fee must be paid as per BPOM’s guidelines. The fees vary depending on the complexity and risk level of the device.
• Translation of Documents: All documents that are not in Bahasa Indonesia must be translated into the local language. This includes product labels, instructions for use (IFU), and certificates.

7. Post-Market Surveillance Compliance

• After obtaining the registration certificate, the manufacturer and authorized representative must comply with Indonesia’s post-market surveillance requirements, which include:
  • Reporting adverse events: If the device causes harm or has other issues during use, these must be reported to BPOM.
  • Product recall: In case of serious safety concerns, the device may need to be recalled, and this process must be managed according to Indonesian regulations.

8. Health Product Risk Assessment (for Certain Devices)

• Some Class II devices might require a Health Product Risk Assessment. BPOM will assess whether the device presents a low to moderate health risk based on its intended use, design, and exposure. Devices that involve high exposure or invasive procedures may undergo additional scrutiny.

9. Device Testing (If Applicable)

• BPOM may request product testing or laboratory reports (e.g., for electrical safety, biocompatibility, or performance) to ensure that the device meets the required safety and efficacy standards.
• Testing could be requested in cases where the device is newly introduced to the Indonesian market or when clinical data is insufficient.

Summary of Conditions to Apply for Class II Medical Device Registration in Indonesia

1. Appointment of a local authorized representative (AR) for foreign manufacturers or an Indonesian importer.
2. Device classification must be accurate, with proper justification for Class II status.
3. Compliance with international standards like ISO 13485 and ISO 14971, including risk management documentation.
4. Submission of necessary certifications, such as Certificate of Free Sale (CFS), ISO 13485, and Good Manufacturing Practices (GMP).
5. Clinical evidence of safety and efficacy (Clinical Evaluation Report or CER).
6. Product labeling and Instructions for Use (IFU) in Bahasa Indonesia.
7. Registration fees must be paid according to BPOM guidelines.
8. Post-market surveillance and reporting obligations must be followed after registration.
9. Risk assessment and product testing, if applicable.

By meeting these conditions, you can ensure a smooth process for registering your Class II medical device in Indonesia. Would you like more specific information or assistance on any of these requirements?

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