Class C Medical Device Registration in Indonesia (MOH)

In Indonesia, medical devices are classified into four categories (Class A, B, C, D) based on their risk level, with Class C being the high-risk category. Class C devices are those that are considered to have a higher potential risk to patients and users, and therefore, they require more extensive regulatory scrutiny during the approval process.

Class C devices typically include:

• High-risk diagnostic devices, such as imaging equipment.
• Implants and surgical instruments.
• Therapeutic devices, such as certain types of medical pumps, dialysis machines, and infusion devices.
• Devices used in critical care, or that have long-term or life-support functions.

Regulatory Authority

The Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), is responsible for the registration and regulation of medical devices in Indonesia.

Class C Medical Device Registration Process in Indonesia

The registration process for a Class C medical device in Indonesia is detailed and requires the submission of comprehensive documentation to BPOM (also known as Badan Pengawas Obat dan Makanan). Here's a step-by-step guide on how to apply:

1. Classification and Eligibility Check

• Determine Classification: Confirm that your device falls under Class C based on the level of risk. This can be done by consulting BPOM guidelines or a local regulatory expert.
• Risk Assessment: Since Class C devices are high-risk, the manufacturer may need to provide more detailed risk management documents, clinical evaluation data, and possibly undergo additional local testing.

2. Appoint an Authorized Representative (AR)

• If you are an overseas manufacturer, you must appoint a local Authorized Representative (AR) based in Indonesia. This AR will handle the submission process and act as a liaison with BPOM.
• The AR must be familiar with the regulatory requirements and Indonesian medical device laws, and will be responsible for ensuring compliance with all regulations, including post-market surveillance.

3. Prepare Required Documentation

The documentation required for Class C medical device registration typically includes the following:

• Product Technical File: Comprehensive documentation about the device, including:
  • Device description and intended use.
  • Design and manufacturing process.
  • Performance and safety data.
  • Compliance with international standards (e.g., ISO 13485, IEC standards).
• Clinical Evaluation Report: Demonstrating the safety and efficacy of the device, usually through clinical studies or relevant clinical data.
• Risk Management File: Based on ISO 14971 or other internationally recognized standards, this document identifies and assesses potential risks related to the device.
• Manufacturing License and Quality Certifications: The manufacturer should provide evidence of good manufacturing practices (GMP), such as ISO 13485 certification.
• Labeling and Instructions for Use (IFU): All labeling, packaging, and instructions must comply with BPOM’s regulations and be in Bahasa Indonesia.
• Certificate of Free Sale (CFS): A document issued by the country's regulatory authority where the device is already marketed (if applicable).
• Other Supporting Documents: Depending on the device, additional documents such as test reports, user manuals, and technical data may be required.

4. Submit the Application via e-Registration

• Submit the application electronically through the e-Registration System managed by BPOM.
• The application must be submitted in Bahasa Indonesia, and all required documents must be uploaded to the portal.
• Your Authorized Representative will be responsible for navigating the e-Registration system and submitting all necessary information to BPOM.

5. BPOM Review and Evaluation

• Technical Evaluation: BPOM will review the submitted documents, technical data, clinical evaluation, and risk management reports. For high-risk devices (Class C), this evaluation can be more rigorous.
• Possible Requests for Additional Data: BPOM may request further clarification or additional documentation if the submitted information is incomplete or insufficient.
• Testing or Inspections: In some cases, BPOM may require local testing or inspections before approval, or may ask for certification from a recognized international regulatory body.

6. Approval and Issuance of Marketing Authorization

• If the device passes the evaluation process, BPOM will issue the Marketing Authorization or NOM (Nomor Registrasi Obat dan Makanan). This authorization grants permission to market the device in Indonesia.
• The marketing authorization is typically valid for 5 years, after which a renewal application is required.

7. Post-Market Surveillance and Compliance

• After obtaining approval and placing the device on the market, the manufacturer (or the Authorized Representative) must maintain post-market surveillance.
• This includes:
  • Reporting adverse events and recalls.
  • Monitoring the device’s performance.
  • Ensuring compliance with regulatory updates or changes.

Post-market monitoring is crucial, especially for high-risk Class C devices, as the regulatory authorities in Indonesia are strict about safety.

Important Considerations

• Language Requirements: All documents must be in Bahasa Indonesia. Ensure that your translations are accurate and comply with local regulations.
• Local Testing: BPOM may require local testing or additional data from accredited Indonesian laboratories.
• Timeframe: The process may take several months, especially for high-risk devices. Planning ahead is crucial for timely market entry.
• Renewal: Marketing authorization is valid for 5 years, and a renewal process must be initiated before the expiration date.
• Compliance: Be prepared for BPOM inspections and audits, particularly if the device is subject to high regulatory scrutiny.

Summary of Steps to Apply

1. Confirm Device Classification (Class C).
2. Appoint a Local Authorized Representative (AR).
3. Prepare Required Documentation (technical file, clinical data, risk management, etc.).
4. Submit the Application via BPOM’s e-Registration System.
5. BPOM Evaluation and possible testing/inspection.
6. Obtain Marketing Authorization (NOM) if approved.
7. Post-Market Surveillance and regulatory compliance.

If you need help with any specific documentation or the role of the Authorized Representative, feel free to ask!

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