For Class I medical device registration with the Indonesia Ministry of Health (MOH), there are specific materials and documents that must be prepared and submitted through the e-RD system (electronic Registration system) managed by the Indonesian National Agency of Drug and Food Control (BPOM). Below is a detailed list of the required materials, along with guidance on how to prepare the application documents.

Materials Required for Class I Medical Device Registration

1. Manufacturer Information

• Business License:
  • This document should confirm that the manufacturer is legally authorized to produce medical devices in their home country. A copy of the manufacturer’s business license or company registration certificate should be included.
• Good Manufacturing Practice (GMP) Certificate:
  • The manufacturer must provide a GMP certificate or an equivalent standard, such as ISO 13485 certification. This proves that the manufacturer follows appropriate quality control processes in the production of medical devices.
• Manufacturing Site Information:
  • Provide details of the manufacturing site where the device is produced. If the device is manufactured in multiple locations, documentation should clearly specify the site that will be responsible for the production and quality assurance.

2. Device Information

• Device Description:
  • A detailed description of the medical device, including:
    • The intended use (what the device is used for).
    • Technical specifications, such as design, materials, and dimensions.
    • Functionality and mechanism of action (if applicable).
    • Photographs or diagrams of the device, if necessary.
• Risk Classification:
  • A document or statement from the manufacturer confirming that the device is classified as Class I based on the Indonesian medical device classification system.
• Device Labeling:
  • The product label should include essential details such as the manufacturer’s name and address, intended use, warnings, and instructions for use.
  • The label must be in Bahasa Indonesia to comply with local regulations.
  • The labeling should meet BPOM’s guidelines for medical device packaging and labeling.
• Product Packaging Information:
  • Details of how the device is packaged (e.g., individual packaging, bulk packaging) and the type of material used. Ensure that the packaging complies with Indonesian packaging requirements.

3. Certificate of Free Sale (CFS)

• CFS is a document issued by the regulatory authority in the manufacturer’s country of origin, certifying that the device is legally available for sale in that market.
  • The CFS should include:
    • Device details (e.g., device name, model, description).
    • Confirmation of legal sale in the home country or other countries where the device is marketed.
    • Approval status in the home country.
  • The CFS must be signed and dated by the relevant health authority in the manufacturer’s home country.
• If the device has been sold in other countries, evidence of market approval in those regions (e.g., CE mark, FDA clearance) can also be submitted in addition to the CFS.

4. Safety and Performance Test Reports (if applicable)

• While Class I devices generally require fewer test reports than higher-risk devices, some Class I devices may still need to provide safety and performance data. These tests could include:
  • Electrical safety testing (for electrical devices).
  • Biocompatibility testing (for devices that come into contact with the body).
  • Sterility testing (if applicable).
• These reports must be from accredited laboratories and demonstrate that the device meets relevant safety and performance standards (e.g., IEC, ISO standards).

5. Product Technical Files

• Technical Files or Design Dossier for the device, including:
  • Design and development process: Documentation of the design process, including any risk analysis, and product development steps.
  • Material specifications: If applicable, provide information about the materials used in the device (especially for implants or other body-contacting devices).

6. Importer or Distributor Information (for imported devices)

• If the device is imported into Indonesia, the importer or distributor must provide the following:
  • Importer’s business license and proof of registration with BPOM.
  • Distributor’s details, including contact information.

7. Declaration of Conformity (if applicable)

• If the device is CE-marked or has other international certifications, include a declaration of conformity stating that the device complies with relevant international standards (e.g., ISO 13485, IEC 60601 for electrical devices).

How to Prepare the Application Documents

Step 1: Translate and Format Documents

• Translate documents such as the product label, user manual, and any safety instructions into Bahasa Indonesia. BPOM requires that these documents be in the official language of Indonesia.
• Ensure that all documents are correctly formatted according to BPOM’s guidelines, with clear and legible text and proper document structure.
• For foreign-language documents, attach certified translations to ensure they are accepted by BPOM.

Step 2: Organize Documents for Submission

• Prepare your documents in the order requested by BPOM, ensuring that each section is complete and includes all relevant information. Ensure that:
  • Each document is signed (if required).
  • Photographs or diagrams of the device are clear and well-labeled.
  • The Certificate of Free Sale (CFS) and test reports are up-to-date and signed by the relevant authorities or organizations.

Step 3: Use the e-RD System

• Your local authorized representative (AR) will be responsible for submitting the registration application through the BPOM e-RD portal. They must:
  • Create an account or log into the e-RD system.
  • Complete the application form for the medical device, providing all required device and manufacturer information.
  • Upload the required documents in the specified format (e.g., PDF, JPG).

e-RD Portal: The system can be accessed at the official BPOM website:
BPOM e-RD Portal

Step 4: Review and Submission

• After completing the application and uploading all necessary documents, review everything carefully to ensure all information is correct and complete.
• Once reviewed, the local authorized representative will submit the application through the e-RD system.

Step 5: Monitor the Application Status

• BPOM will conduct a review of the submission and may request additional documents or clarifications if necessary. The local AR should monitor the application status in the e-RD system.
• BPOM may take 2-4 weeks for review, but this timeline can vary based on the complexity of the device and the completeness of the application.

Important Considerations

1. Document Quality:

   • Ensure that all documents are of high quality, legible, and complete. Missing or incomplete documents can lead to delays.

2. Translation Compliance:

   • All relevant documents, including labels, instructions, and user manuals, must be translated into Bahasa Indonesia. Accurate translations are essential to avoid rejection.

3. Authorized Representative:

   • Only an Indonesian authorized representative (AR) can submit the registration through the e-RD system, so ensure you have a reliable AR that is familiar with Indonesian regulations.

4. Regulatory Updates:

   • Keep track of any regulatory updates from BPOM, as medical device regulations in Indonesia may evolve, especially with regard to new documentation or testing requirements.

By carefully preparing the required materials, ensuring compliance with Indonesian regulations, and working with an experienced local authorized representative, you can streamline the registration process and ensure a smooth application for your Class I medical device in Indonesia.

If you have further questions or need assistance with specific parts of the process, feel free to reach out!

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