For D-class medical device registration with the Ministry of Health (MOH) in Indonesia, through the National Agency of Drug and Food Control (BPOM), the technical documentation requirements are generally less stringent compared to higher-risk medical devices. However, you still need to provide comprehensive documentation to demonstrate that the device is safe, effective, and compliant with Indonesian regulations.

Key Technical Document Requirements for D-Class Medical Device Registration:

1. Product Description and Specifications

• Details required:
  • Name of the device: The brand name and model number.
  • Intended use: Clear description of what the device is intended for (e.g., diagnostic tool, therapeutic device, monitoring instrument).
  • Technical specifications: Detailed information on the device's design, materials, components, and intended operating environment (e.g., temperature, humidity).
  • Functionality: How the device operates and its main features.

2. Risk Classification Justification

• Required documentation:
  • Justification of the device's classification as a D-class (low-risk) device. You will need to provide supporting documentation explaining how the device meets the criteria for low-risk classification under Indonesian regulations (which are aligned with international standards such as IMDRF or GHTF).
  • A description of the device’s risk profile, demonstrating that it presents minimal risk to the patient and user, and that it does not require complex risk management processes.

3. Certificate of Free Sale (CFS)

• Required for foreign manufacturers:
  • A Certificate of Free Sale (CFS) issued by the competent regulatory authority in the country of origin (e.g., the FDA in the United States, CE certification in Europe).
  • This document confirms that the device is legally sold and marketed in the country of origin.
  • The CFS should be recent (usually not older than 1 year) and should apply specifically to the product being registered.

4. Quality Management System (QMS) Documentation (if applicable)

• Required for manufacturers that have an established QMS:
  • If the device is manufactured under a recognized Quality Management System (QMS) (e.g., ISO 13485:2016), a copy of the ISO certification or other relevant QMS documentation should be provided.
  • This is generally required for manufacturers who have a formal quality management system in place, but for low-risk (D-class) devices, it may not always be mandatory unless specified by BPOM.

5. Labeling and Instructions for Use (IFU)

• Required documentation:
  • Product labeling: The device's label must include key information such as the product name, manufacturer's details, model number, batch/serial number, expiry date (if applicable), and storage instructions. Labels must be compliant with Indonesian labeling regulations.
  • Instructions for Use (IFU): The IFU must be clear, concise, and in the Indonesian language (or with an official translation into Indonesian). It should include:
    • Device handling and operating instructions
    • Safety warnings and precautions
    • Contraindications (if applicable)
    • Maintenance and storage instructions

6. Product Testing and Performance Data

• Required documentation:
  • Test reports showing that the device meets safety and performance standards. While D-class devices generally do not require clinical trials, BPOM may request performance test data to ensure the device functions as intended.
  • For electrical or mechanical devices, provide reports for electrical safety, biocompatibility, and mechanical performance (if applicable).
  • If the device involves any form of sterilization or reusable components, sterility assurance data may also be required.

7. Manufacturing Information

• Required documentation:
  • A description of the manufacturing process and the facilities where the device is produced. BPOM may request proof that the manufacturing site adheres to international good manufacturing practices (GMP).
  • Manufacturing site license: If applicable, documentation that confirms the facility meets the required Good Manufacturing Practices (GMP).

8. Product Declaration or Conformity Statement (if applicable)

• Required for some devices:
  • A conformity statement or product declaration stating that the device complies with applicable international standards (e.g., ISO 13485, IEC 60601, or ISO 14971).
  • This may include conformity to EU standards (for CE-marked devices) or FDA standards (for devices approved by the U.S. FDA).

9. Local Distributor or Representative Agreement (for foreign manufacturers)

• Required for foreign manufacturers:
  • A signed agreement between the foreign manufacturer and the local distributor or authorized representative in Indonesia. This agreement should clearly outline the responsibilities of both parties, including product registration, marketing, and post-market surveillance.

10. Clinical Evaluation (if applicable)

• Optional for D-class devices: In general, D-class devices do not require clinical evaluation data. However, BPOM may request clinical data if the device’s intended use or risk profile warrants it. If you are submitting data for clinical evaluation, it must be in accordance with Indonesian clinical trial guidelines.

Summary of Key Technical Documents:

1. Product Description and Specifications
2. Risk Classification Justification
3. Certificate of Free Sale (CFS)
4. Quality Management System (QMS) Documentation (if applicable)
5. Labeling and Instructions for Use (IFU)
6. Product Testing and Performance Data
7. Manufacturing Information and Site License
8. Product Declaration or Conformity Statement
9. Local Distributor or Representative Agreement
10. Clinical Evaluation (if applicable)

Preparation Tips:

• Ensure Accuracy and Completeness: Verify that all documents are complete, accurate, and up-to-date. Any missing or inaccurate information can delay the registration process.
• Certified Translations: If your documents are in a foreign language, ensure they are translated into Indonesian by a certified translator.
• Collaborate with Local Representative: Work closely with your local authorized representative or distributor in Indonesia to ensure that all documentation complies with local requirements.

By preparing these key technical documents in advance and ensuring that they meet the necessary regulatory standards, you can help expedite the registration process for your D-class medical device in Indonesia.

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