To apply for D-class medical device registration with the Indonesian Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), certain conditions and criteria must be met to ensure compliance with local regulations. D-class devices are classified as low-risk medical devices, so the regulatory requirements for their registration are generally less stringent compared to higher-risk devices, but they still need to meet specific conditions.

1. Conditions for D-Class Medical Device Registration in Indonesia

A. Classification of the Device

• D-class devices are low-risk medical devices. They typically include non-invasive devices that do not present significant risks to the patient or user. Common examples may include basic diagnostic instruments or non-invasive monitoring devices.
• Condition: The device must meet the D-class (low-risk) classification according to the Indonesian medical device risk classification framework, which is based on international standards (e.g., the GHTF/ IMDRF framework, EU MDR, or FDA classification).
  • The device should have minimal potential for harm under normal use conditions.
  • The device does not require clinical trial data for registration in most cases.
• Action: You must provide evidence or documentation to justify why the device qualifies as a D-class device. This may involve using international risk classification standards.

B. Local Authorized Representative or Distributor

• Condition: If the manufacturer is based outside of Indonesia, a local authorized representative or distributor in Indonesia must be appointed to handle the registration process.
  • The local representative will serve as the point of contact for BPOM and must be registered with BPOM as an authorized entity.
  • The representative is responsible for submitting the registration application, communicating with BPOM, and ensuring the device is compliant with Indonesian laws.
• Action: Establish an agreement with a local distributor or authorized representative who will submit the registration application on your behalf.

C. Compliance with Indonesian Regulatory Requirements

• Condition: The medical device must meet Indonesian regulatory standards for medical devices, including those related to product safety, performance, and quality.
  • The device should adhere to the Indonesian Health Ministry’s regulations on medical device safety and quality.
  • Ensure compliance with relevant Indonesian standards for labeling, packaging, and usage instructions.
• Action: Review BPOM's guidelines on medical device safety standards and ensure your product meets the required safety and labeling criteria.

D. Proper Documentation

• Condition: The device registration application must include all necessary documentation, which may include:
  1. Certificate of Free Sale (CFS) from the country of origin (if applicable), confirming the device is legally marketed and sold in its home country.
  2. Risk classification evidence that supports the classification of the device as D-class.
  3. Product description and specifications, detailing the device's intended use, design, and performance characteristics.
  4. Labeling and instructions for use (IFU) in Indonesian or with a certified translation.
  5. Quality Management System (QMS) documentation, if applicable (e.g., ISO 13485).
  6. Local distributor or representative agreement (for foreign manufacturers).
• Action: Ensure all required documents are prepared, translated into Indonesian, and meet BPOM’s specific document submission guidelines. Missing or incomplete documents will delay the registration process.

E. Compliance with Labeling and Instruction Requirements

• Condition: All medical devices must meet Indonesian labeling requirements. This includes providing clear and accurate labeling in Indonesian, especially for:
  • Product name, model, and manufacturer information
  • Batch/serial number, expiration date (if applicable)
  • Usage instructions (Instructions for Use/IFU)
  • Safety warnings and handling instructions
  • Storage conditions
• Action: Ensure that the labeling is compliant with Indonesian regulations. If the labeling is in a foreign language, it must be accompanied by a certified Indonesian translation.

F. Device Performance and Safety Documentation

• Condition: D-class devices typically do not require clinical trials, but documentation demonstrating that the device meets international safety standards (e.g., ISO 13485, IEC 60601 for electrical safety) may still be needed.
  • For electrical or mechanical devices, safety testing reports may be required (e.g., biocompatibility, electrical safety testing).
• Action: Ensure the device is tested for safety and performance, especially if it is electrical, mechanical, or invasive in any way.

G. Payment of Registration Fees

• Condition: You must pay the required registration fees as determined by BPOM.
  • The registration fee is typically between IDR 5,000,000 to IDR 10,000,000 (approximately USD 300 to USD 650) for D-class devices.
• Action: Prepare for payment of the registration fee after the application is submitted via BPOM's online payment system.

H. Validity of Certificate of Free Sale (CFS)

• Condition: The CFS from the country of origin should be valid and cover the specific medical device being registered. It must confirm that the device is approved for sale in the country of origin.
  • If the CFS is more than a year old, BPOM may ask for a more recent version of the certificate.
• Action: Ensure the CFS is up-to-date and correctly references the device being registered.

I. Device Risk and Classification Justification

• Condition: As a D-class medical device, it must be classified as low-risk based on the device’s intended use, nature, and safety profile.
  • D-class devices generally have minimal risk and do not involve high patient interaction or require extensive clinical trials.
• Action: Provide adequate justification for why the device qualifies as low-risk according to BPOM’s guidelines and international classification systems.

2. Key Steps to Ensure Eligibility for D-Class Registration

1. Appoint a Local Representative/Distributor (if applicable)

   • Foreign manufacturers need a local authorized representative or distributor in Indonesia.

2. Ensure the Device is Classified as D-Class

   • Verify the device meets the definition of a low-risk device (D-class) based on its intended use and the relevant regulatory classification standards.

3. Prepare and Submit the Required Documents

   • Ensure you have all the necessary documents, such as CFS, product description, risk classification evidence, labeling, and quality management documentation.

4. Ensure Compliance with Indonesian Labeling and IFU Requirements

   • Labeling and instructions for use must be in Indonesian or contain certified translations.

5. Pay the Registration Fee

   • Be prepared to pay the registration fee through BPOM's online payment system after submission.

6. Follow Up on Application Status

   • After submission, monitor your application through the BPOM e-Registration portal for any updates or requests for additional information.

Conclusion

To apply for D-class medical device registration in Indonesia, you must ensure your device is classified as low-risk, meet Indonesian regulatory requirements, and provide all necessary documentation via the BPOM e-Registration system. Key conditions include appointing a local authorized representative (if applicable), ensuring compliance with Indonesian labeling and IFU requirements, and paying the necessary registration fees. By following these steps and preparing the required documentation carefully, you can successfully navigate the registration process.

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