The process for registering a Class C medical device with the Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), involves several detailed steps. Class C medical devices are classified as high-risk devices, meaning they require a thorough evaluation process to ensure their safety, quality, and efficacy.

Here’s an overview of the process and steps for Class C medical device registration in Indonesia:

1. Classify the Device

• Confirm the Classification: Ensure that the device falls under Class C by reviewing its risk profile. Class C devices are high-risk and typically include implants, critical care devices, diagnostic imaging devices, etc.
• Device Risk Assessment: BPOM will assess the device based on its risk level. Devices that are implantable, life-supporting, or critical for health tend to fall under Class C.

2. Appoint an Authorized Representative (AR)

• Foreign Manufacturers: If you are a manufacturer based outside Indonesia, you must appoint a local Authorized Representative (AR) who is based in Indonesia. The AR will handle the submission process and communication with BPOM on behalf of the foreign manufacturer.
• Role of AR: The AR ensures compliance with local regulations, submits registration documents, responds to BPOM inquiries, and manages post-market surveillance.

3. Prepare Required Documentation

Prepare comprehensive documentation that meets BPOM’s requirements for Class C devices. The key documents include:

• Product Technical File: A detailed file that includes:

  • Device description, intended use, and classification.
  • Manufacturing processes and design information.
  • Compliance with international standards (e.g., ISO 13485, IEC standards).
  • Device specifications, safety features, and performance characteristics.

• Clinical Evaluation Report: Documentation showing that the device has been clinically evaluated and is proven to be safe and effective. If required, clinical trials or data from international clinical studies may be needed.

• Risk Management Report: Based on ISO 14971, detailing how the device’s risks are identified, assessed, and mitigated throughout its lifecycle.

• Quality Management System (QMS) Certifications: Evidence of compliance with international QMS standards (e.g., ISO 13485).

• Manufacturing License: Proof that the manufacturer complies with local regulatory requirements for production, including Good Manufacturing Practices (GMP).

• Certificate of Free Sale (CFS): If applicable, the CFS is a document issued by the regulatory authority of the country where the device is marketed, confirming that the device is legally sold in that country.

• Labeling and Instructions for Use (IFU): All product labeling, packaging, and instructions must comply with Indonesian regulations and be provided in Bahasa Indonesia.

• Test Reports and Certifications: Relevant test data and certifications from accredited labs, showing compliance with safety and performance standards.

4. Submit the Registration Application

The registration process is conducted via BPOM's e-Registration System. The Authorized Representative (AR) will submit the registration application electronically, which must include:

• The completed registration form.
• All required documents in Bahasa Indonesia (translated if necessary).
• The registration fee payment, if applicable.

5. BPOM Evaluation and Review

• Document Review: BPOM will assess the submitted technical file, clinical evaluation, risk management, and other required documents. The evaluation focuses on ensuring that the device meets safety, quality, and regulatory standards.

• Further Information Requests: BPOM may request additional information or clarifications during their review. This is common in high-risk Class C device registrations, as more detailed assessments may be required.

• Testing and Inspections: BPOM may require the submission of additional test reports or ask for the device to be tested by accredited laboratories in Indonesia. In some cases, BPOM may conduct on-site inspections of the manufacturing facilities.

6. BPOM Decision and Issuance of Marketing Authorization (NOM)

• If the evaluation is successful and the device meets all regulatory requirements, BPOM will issue a Marketing Authorization (often referred to as NOM - Nomor Registrasi Obat dan Makanan).
• The marketing authorization is generally valid for 5 years. After the 5-year period, a renewal application is required.

7. Post-Market Surveillance

After the device is marketed in Indonesia, the Authorized Representative (AR) must ensure compliance with post-market surveillance requirements, including:

• Adverse Event Reporting: Any adverse events or product failures must be reported to BPOM.
• Recalls and Corrective Actions: If the device is found to be unsafe or defective, the manufacturer and AR are responsible for initiating recalls or corrective actions.
• Ongoing Compliance: Monitoring the device's performance and ensuring compliance with any updated regulatory requirements.

Key Considerations

• Language Requirements: All documents submitted to BPOM must be in Bahasa Indonesia. This includes product labeling, clinical evaluation reports, and user manuals.
• Testing: Class C devices may require local testing in Indonesian accredited laboratories, or testing reports from recognized international standards.
• Timeframe: The registration process for Class C devices can take several months, depending on the complexity of the device and the completeness of the application.
• Regulatory Changes: Stay updated with any changes in regulations, as Indonesian medical device laws may evolve over time.

Summary of Steps for Class C Medical Device Registration in Indonesia

1. Classify the device: Confirm that your device is classified as Class C (high-risk).
2. Appoint an Authorized Representative (AR): Essential for foreign manufacturers.
3. Prepare documentation: Includes product technical files, clinical evaluations, risk management reports, quality certifications, and labeling in Bahasa Indonesia.
4. Submit the application: Via BPOM's e-Registration system by the Authorized Representative.
5. BPOM review: BPOM evaluates the application, may request additional information, and may require testing.
6. Obtain Marketing Authorization (NOM): Upon successful approval, BPOM grants marketing authorization.
7. Post-market surveillance: Ongoing monitoring and reporting of adverse events and device performance.

If you need assistance with any specific step in the process, such as preparing documentation or finding a local Authorized Representative, feel free to ask!

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