For D-class medical device registration in Indonesia with the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), specific materials and documentation are required to ensure compliance with Indonesian regulatory standards. D-class devices are typically low-risk devices, and while the registration process is generally simpler than for higher-risk devices, the submission of correct and complete documents is still essential.

Here’s a list of the materials you will need, and guidance on how to prepare the application documents:

1. Materials Needed for D-Class Medical Device Registration

A. Certificate of Free Sale (CFS)

• What it is: A Certificate of Free Sale (CFS) is issued by the regulatory authority in the device's country of origin (e.g., FDA, CE marking, etc.). The CFS confirms that the device is legally sold in the country of origin and complies with the relevant regulations there.
• Requirements:
  • The CFS must be valid and issued by the regulatory authority.
  • It must be in Indonesian or accompanied by a certified translation into Indonesian.
• Preparation Tips:
  • Ensure the CFS is up-to-date, with the correct product details matching the device you intend to register.

B. Product Description and Specifications

• What it is: Detailed technical information about the device, including its intended use, features, and design.
• Requirements:
  • A clear and concise product description outlining the intended purpose and functionality of the device.
  • Device specifications such as materials, dimensions, operating principle, and any relevant technical details.
• Preparation Tips:
  • Use simple and clear language to describe the device.
  • Highlight key features and safety aspects.
  • Include any necessary diagrams, pictures, or charts that explain the device’s functionality.

C. Risk Classification Evidence

• What it is: Documentation that shows the device is classified as D-class (low-risk) according to the Indonesian regulatory framework.
• Requirements:
  • Provide a risk classification document that justifies why the device falls under D-class.
  • This could be based on international classification systems (e.g., the MDR classification in Europe or the FDA classification in the United States).
• Preparation Tips:
  • Clearly state the classification of the device in the context of Indonesian regulations.
  • If needed, provide expert analysis or justification for classification.

D. Labeling and Instructions for Use (IFU)

• What it is: The labeling includes all the information on the device packaging, and the Instructions for Use (IFU) provide detailed guidance for the safe use of the device.
• Requirements:
  • Device labeling should include:
    • Product name and model
    • Manufacturer and importer details
    • Batch/lot number, expiration date (if applicable)
    • Storage and handling instructions
    • Warnings and precautions
  • Instructions for Use (IFU) must include:
    • Step-by-step usage instructions
    • Safety and cleaning information
    • Contraindications, warnings, and precautions
• Language Requirements:
  • All labeling and IFUs must be in Indonesian or include certified translations.
• Preparation Tips:
  • Ensure that the labeling is clear, concise, and in compliance with Indonesian language requirements.
  • The IFU must be easy to understand, especially for the intended user in Indonesia.

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

• What it is: Evidence that the manufacturer complies with international quality standards, such as ISO 13485 (Quality Management System for medical devices).
• Requirements:
  • If applicable, submit ISO 13485 certification or other quality assurance documents that prove the manufacturer’s adherence to good manufacturing practices (GMP).
• Preparation Tips:
  • Ensure that the QMS documents are up-to-date and relevant to the product being registered.
  • If the device does not require ISO 13485, ensure the other documentation reflects the safety and quality standards of the device.

F. Distributor/Authorized Representative Agreement

• What it is: If the manufacturer is not located in Indonesia, the registration must be done by an authorized representative or distributor in Indonesia.
• Requirements:
  • Submit a signed agreement between the foreign manufacturer and the local distributor or representative. This document should specify the role of the local representative in handling the registration process and product distribution in Indonesia.
• Preparation Tips:
  • Ensure the agreement includes the responsibilities of both parties and is signed by authorized individuals.
  • Include the local distributor's business registration (SIUP) and tax identification number (NPWP) in Indonesia.

G. Other Regulatory Documents (if applicable)

• What it is: Depending on the type of device, additional documents may be required, such as:
  • Clinical data (if applicable for performance claims)
  • Safety testing results (e.g., electrical safety, biocompatibility tests, etc.)
  • Customs documentation for importation (if applicable)

2. How to Prepare the Application Documents

The preparation of the documents for D-class medical device registration is crucial for smooth processing. Follow these steps to ensure everything is ready for submission:

A. Review Indonesian Regulations and Guidelines

• Familiarize yourself with the relevant Indonesian medical device regulations outlined by BPOM, including the requirements for D-class devices.
• Visit BPOM’s official website and read up on the e-Registration system guidelines.

B. Complete the Application Form

• Once you have all the required materials, log into the BPOM e-Registration system to complete the registration form.
• The form will require detailed information about your device, including product description, manufacturer details, risk classification, and more.
• Ensure that all information is accurate and complete before submitting.

C. Translate the Documents into Indonesian

• All documents required for registration (except for the CFS and international certifications) must be in Indonesian or include certified translations.
• Work with a certified translator to ensure the accuracy and professionalism of the translations, especially for technical terms in the Instructions for Use and labeling.

D. Submit the Documents via BPOM e-Registration Portal

• Log into the e-Registration portal and submit the application along with all supporting documents.
• Make sure all files are in the correct format (PDF, JPEG, etc.) and the document sizes meet BPOM’s submission requirements.

E. Pay the Registration Fee

• Once your documents are submitted, you will need to pay the registration fee via BPOM’s online payment system. The fee for D-class devices typically ranges from IDR 5,000,000 to IDR 10,000,000 (approximately USD 300 to USD 650).

F. Monitor Application Status

• After submission, BPOM will review the documents and may request additional information or clarification. Monitor your e-Registration account regularly for updates or requests from BPOM.
• If BPOM needs additional documentation, respond promptly to avoid delays.

3. Key Points to Ensure a Successful Application

• Complete Documentation: Double-check that all required documents are included and complete, especially the Indonesian translations.
• Accurate Product Description: Ensure the product description clearly outlines the intended use and specifications of the device.
• Clear and Compliant Labeling: Ensure all labels and instructions for use are compliant with Indonesian requirements and are translated into Indonesian.
• Local Representation: Ensure that a local distributor or authorized representative is involved in the registration process.

By following these steps and preparing the required materials thoroughly, you can ensure that your D-class medical device registration in Indonesia is completed efficiently and in compliance with local regulations.

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