Materials Required for Class A Medical Device Registration with Indonesia MOH

To register a Class A (low-risk) medical device with the Ministry of Health (MOH) in Indonesia, you must provide comprehensive administrative and technical documentation. Below is a list of required materials and guidance on how to prepare them:

1. Required Materials

Administrative Documents

1. Local Authorized Representative Details:

   • Business license (SIUP) or equivalent document of the local representative.
   • Tax Identification Number (NPWP) of the local representative.
   • Contact information of the representative registered with the MOH.

2. Letter of Authorization/Appointment:

   • A letter from the manufacturer authorizing the local representative to act on their behalf.
   • Must be notarized and legalized if issued outside Indonesia.

3. Certificate of Free Sale (CFS):

   • Issued by the competent authority in the country of origin.
   • Confirms the device is legally marketed in the originating country.

4. ISO 13485 Certificate:

   • Demonstrates the manufacturer’s compliance with international quality management system standards for medical devices.
   • Must be valid and issued by an accredited certification body.

Technical Documents

1. Product Description:

   • Device name, model, and classification (Class A).
   • Intended use and description of the device’s main features.

2. Risk Management Documentation:

   • Risk analysis and risk mitigation details in compliance with ISO 14971 standards.

3. Safety and Performance Data:

   • Reports demonstrating the device meets safety and performance requirements, such as biocompatibility, electrical safety, or sterility (if applicable).

4. Labeling:

   • Product label must include:
     • Device name and model.
     • Manufacturer’s name and address.
     • Local representative’s name and address.
     • Lot or serial number.
     • Instructions, precautions, and warnings.
   • Label text must be translated into Bahasa Indonesia.

5. Instructions for Use (IFU):

   • A detailed guide explaining how to use the device, safety precautions, and any contraindications.
   • Translated into Bahasa Indonesia.

6. Packaging Information:

   • Description or image of the device’s packaging, including primary and secondary packaging.

7. Declaration of Conformity:

   • A declaration from the manufacturer stating the device conforms to applicable standards and regulations.

2. Preparing the Application Documents

Step 1: Gather Original Documents

• Collect the required certificates (e.g., ISO 13485, CFS) from the manufacturer.
• Ensure all documents are valid, up-to-date, and issued by recognized authorities.

Step 2: Translate into Bahasa Indonesia

• All documents, labels, and instructions must be translated into Bahasa Indonesia by a certified translator.

Step 3: Verify Legalization Requirements

• Some documents, such as the Letter of Authorization and CFS, may require notarization or legalization by the Indonesian Embassy in the country of origin.

Step 4: Format Documents According to ASPAK Requirements

• Ensure all files are in the required formats (usually PDF or JPEG for images).
• Label each file clearly, indicating its content (e.g., "ISO 13485 Certificate.pdf").

Step 5: Compile a Complete Dossier

• Combine administrative and technical documents into a well-organized dossier.
• Ensure all required details are included and consistent across all documents.

Step 6: Submit via ASPAK

• Log in to the ASPAK portal and upload the documents to complete the application process.

3. Key Tips for Preparation

• Accuracy: Ensure all information (e.g., names, addresses) matches across all documents.
• Compliance: Verify the device’s classification (Class A) and regulatory compliance.
• Translation Quality: Use certified translators to avoid issues with Bahasa Indonesia translations.
• Representative Selection: Choose an experienced local representative familiar with MOH requirements.

If you would like help drafting or reviewing specific documents, let me know!

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