To apply for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), certain conditions must be met to ensure the device complies with Indonesia's regulatory requirements. These conditions primarily revolve around safety, efficacy, quality control, and compliance with local regulations.

Here are the key conditions that must be fulfilled to apply for Class C medical device registration in Indonesia:

1. Device Classification

• Correct Classification: The device must be correctly classified as Class C according to the risk-based classification system set by BPOM. Class C devices are considered moderately high-risk devices (e.g., surgical equipment, diagnostic devices, implants).
• Ensure that the device meets the criteria for Class C by evaluating its intended use, contact with the human body, and the risks involved.

2. Manufacturer's Compliance

• Valid Manufacturing License: The manufacturing facility must have a valid Manufacturing License issued by the relevant regulatory authorities in the country where the device is produced.
• GMP Certification: The manufacturing facility must comply with Good Manufacturing Practices (GMP) standards. This is to ensure that the medical device is manufactured under controlled, quality-assured conditions.
• Foreign Manufacturer Requirements: If the device is manufactured outside of Indonesia, a local Authorized Representative (AR) must be appointed to act on behalf of the manufacturer and handle the registration process in Indonesia.

3. Authorized Representative (AR)

• Local AR for Foreign Manufacturers: If the manufacturer is based outside Indonesia, they must appoint a local Authorized Representative (AR) in Indonesia who is a legally registered entity in the country. The AR will be responsible for submitting the registration application and communicating with BPOM.
• The AR must have the capacity to manage regulatory affairs and ensure compliance with Indonesian regulations.

4. Compliance with Indonesian Regulatory Standards

• Conformance to Indonesian Regulations: The device must meet the technical and regulatory standards specified by BPOM and other relevant Indonesian authorities. This includes compliance with Indonesian National Standards (SNI) and international standards that are recognized by BPOM (such as ISO, IEC, etc.).
• Ensure that the device has passed necessary international regulatory standards (e.g., CE Mark, FDA approval) if applicable, as BPOM may require proof of such certifications.

5. Preparation of Documentation

• Product Technical File: A technical file containing all the required information about the device, including:
  • Device description and classification.
  • Intended use and indications.
  • Materials and components.
  • Manufacturing process.
  • Compliance with safety and performance standards.
• Clinical Evaluation Report: A report containing clinical data or evidence of the safety and efficacy of the device. If the device is already marketed in other countries (e.g., Europe, USA), clinical data and performance studies from these regions may be submitted.
• Risk Management File: A risk analysis file demonstrating that potential risks have been identified and mitigated in compliance with ISO 14971.
• Labeling and Instructions for Use (IFU): Labels and usage instructions must be provided in Bahasa Indonesia. The labeling should include all required details such as the device name, manufacturer's details, intended use, warnings, and handling instructions.

6. Certificate of Free Sale (CFS)

• A Certificate of Free Sale (CFS) issued by the regulatory authority of the country where the device is manufactured or already marketed. This document proves that the device is legally sold in other markets and is compliant with the regulatory standards of the originating country.
• The CFS must be up-to-date and issued by a recognized authority (e.g., FDA, EMA, or other major regulatory bodies).

7. Biocompatibility and Performance Testing

• If the device comes into contact with the human body (e.g., implants, medical devices in direct contact with patients), it must undergo biocompatibility testing in accordance with ISO 10993 to ensure that the materials used are safe.
• Performance Testing: BPOM may require performance testing results (especially for electrical medical devices), which must comply with international standards such as IEC 60601 for electrical safety or ISO 13485 for quality management.

8. Post-Market Surveillance and Reporting

• Post-Market Surveillance (PMS): After obtaining the marketing authorization, the manufacturer (or AR) must establish procedures for post-market surveillance, including reporting adverse events or recalls, in compliance with Indonesian regulatory requirements.
• The reporting of adverse events and device issues to BPOM is mandatory, and the manufacturer must act promptly to resolve any safety concerns.

9. Device Packaging and Labeling Requirements

• The device packaging must include clear labeling and information as per BPOM requirements:
  • The device name, model, and serial number (if applicable).
  • Manufacturer or distributor details.
  • Intended use and indications.
  • Warnings, contraindications, and precautions.
• The labeling must be in Bahasa Indonesia and must meet BPOM's specific labeling guidelines for medical devices.

10. Device Performance and Safety

• Safety and Effectiveness: The device must be proven to be safe and effective for its intended use. BPOM evaluates whether the benefits outweigh the risks and whether the device complies with international standards for safety and performance.
• Performance testing may be required to validate the device’s claims.

11. Device Stability and Shelf-Life (if applicable)

• Stability Data: If the device is subject to stability concerns (e.g., for disposable devices, sterile devices), BPOM may request stability data to ensure that the device maintains its intended performance during its shelf-life.

12. Fees for Registration

• Ensure that the registration fee is paid as required by BPOM. The fee is typically based on the device classification, with Class C devices falling into a moderate fee category.

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

1. Correct classification of the device as Class C.
2. The manufacturer must have a valid manufacturing license and GMP certification.
3. Authorized Representative (AR) in Indonesia must be appointed for foreign manufacturers.
4. Compliance with Indonesian regulatory standards, including SNI and international standards.
5. Preparation of a complete application file, including clinical data, risk management, labeling, and instructions for use in Bahasa Indonesia.
6. Certificate of Free Sale (CFS) from the country of origin.
7. Biocompatibility and performance testing (if applicable).
8. Post-market surveillance and adverse event reporting compliance.
9. Device packaging and labeling must meet BPOM’s requirements.
10. Payment of registration fees.

Once these conditions are met, the device can be submitted through the BPOM e-Registration System for evaluation and approval.

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