Before applying for Class II medical device registration with the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) in Indonesia, it's essential to prepare thoroughly to ensure that your application is complete, accurate, and compliant with Indonesian regulations. Proper preparation will help streamline the registration process and reduce the likelihood of delays or rejections. Here’s a step-by-step guide on what needs to be prepared before submitting your application:

1. Understand the Classification and Regulatory Requirements

• Confirm Device Classification:

  • Ensure your device is correctly classified as Class II under Indonesian regulations. Class II devices are generally considered to pose moderate risk to patients or users. If you're unsure about the classification, consult BPOM’s guidelines or seek advice from a regulatory expert.

• Familiarize Yourself with BPOM Guidelines:

  • Review the relevant regulations and guidelines issued by BPOM and the Ministry of Health. Familiarize yourself with the Regulation of the Minister of Health No. 62/2017 and BPOM’s Regulation No. 27/2017 on medical device registration, as well as any specific rules that apply to your device category.

2. Designate an Authorized Representative (AR) in Indonesia (for Foreign Manufacturers)

If you are a foreign manufacturer:

• Appoint an Authorized Representative (AR):
  • You must appoint a local authorized representative in Indonesia to handle the registration process and communication with BPOM. The AR is responsible for submitting documents, receiving notifications from BPOM, and ensuring regulatory compliance.
• Obtain Required Documentation:
  • Ensure the AR has all necessary documents to represent you legally in Indonesia, such as a power of attorney and a letter of authorization.

3. Prepare the Necessary Documentation

Gather all required technical and regulatory documents for submission. These include the following:

Basic Company Documentation

• Business License:
  • Ensure that the manufacturer (or the authorized representative, if applicable) has a valid business license for manufacturing, importing, and distributing medical devices in Indonesia.
• Import License (if applicable):
  • If the device is imported, the importer must have a valid BPOM import license.

Device-Specific Documents

• Certificate of Free Sale (CFS):

  • Provide a Certificate of Free Sale from the country of origin, proving that the device is legally sold in the manufacturer's home country or other countries. This document may need to be legalized by the Indonesian embassy in the country of origin.

• ISO Certifications:

  • ISO 13485 (Quality Management System) and other relevant ISO certifications such as ISO 14971 (Risk Management) or ISO 9001 (General Quality Management) may be required to demonstrate compliance with international quality standards.

• Product Technical Data:

  • Detailed product specifications and technical data sheets describing the device’s features, functionality, and intended use.

• Clinical Evaluation Report (CER):

  • If the device requires clinical data for evaluation (especially for higher-risk devices), prepare a clinical evaluation report demonstrating that the device has been tested for safety and effectiveness in accordance with ISO 14155 or similar standards.

• Risk Management File:

  • A risk management file in accordance with ISO 14971 that includes an evaluation of potential risks associated with the device and the measures taken to mitigate these risks.

• Biocompatibility and Safety Data:

  • For devices that come into direct contact with the human body, provide biocompatibility data (e.g., testing in compliance with ISO 10993) showing that the device is safe for use.

Product Labeling and Instructions for Use (IFU)

• Bahasa Indonesia Labeling:

  • Prepare the labels and Instructions for Use (IFU) in Bahasa Indonesia, ensuring that they meet BPOM’s language and content requirements. Labels should include:
    • Product name
    • Manufacturer’s name and address
    • Device’s intended use
    • Warnings and precautions
    • Expiry date (if applicable)
    • Storage and handling instructions

• Packaging Requirements:

  • Ensure that the device packaging complies with Indonesian packaging standards and includes appropriate symbols in line with ISO 15223-1 for medical device labeling.

GMP (Good Manufacturing Practice) Certificate:

• A valid GMP certificate is required to confirm that the manufacturer operates in accordance with internationally recognized manufacturing practices. This is especially critical for imported devices.

4. Complete and Review the Registration Application Form

• BPOM Registration Form:

  • Download the BPOM registration form from the BPOM website or the BPOM e-registration portal. Complete the form with the correct product details, including the device’s name, classification, intended use, and technical specifications.

• Ensure Accurate and Complete Information:

  • Ensure that all sections of the form are filled out accurately. Any missing or incorrect information could delay the registration process.

5. Establish Local Distribution Channels (If Applicable)

• Identify Local Distributors:
  • If the device is to be distributed in Indonesia, ensure that your local distributor is authorized to distribute medical devices and complies with local regulations.
• Distributor Agreements:
  • Establish distribution agreements with authorized distributors that comply with BPOM’s regulations for medical device distribution.

6. Compliance with BPOM’s Inspection and Audit Requirements

• Prepare for Inspections (if applicable):
  • If BPOM requires an inspection of your manufacturing facility (either domestic or overseas), ensure that your facility complies with Good Manufacturing Practice (GMP) and other regulatory standards. Be ready to provide access for BPOM inspectors, if necessary.
• Prepare Documentation for Inspection:
  • Have documentation available to demonstrate that the device is being manufactured in compliance with regulatory and safety standards.

7. Review the Fees and Payment Process

• Registration Fees:

  • Be aware of the registration fees for Class II medical devices. Fees may vary depending on the type of device and whether it is an imported product. Ensure that payment is made according to BPOM’s procedures, and keep receipts for your records.

• Payment Method:

  • Check BPOM’s official payment methods, as payments may be made via bank transfer, e-payment, or other methods designated by BPOM.

8. Plan for Ongoing Post-Market Surveillance (PMS)

• Establish Post-Market Monitoring Procedures:
  • Prepare to implement post-market surveillance procedures to monitor the performance of the device once it is in the market. This includes tracking any adverse events or product recalls.
• Adverse Event Reporting Mechanism:
  • Set up a system to track adverse events or customer complaints and be prepared to report them to BPOM as required by Indonesian regulations.

9. Prepare for Registration Follow-Up

• Respond to BPOM Requests:

  • BPOM may request additional information or clarification during the registration process. Be ready to respond promptly to any inquiries or requests for more detailed documentation.

• Track Application Status:

  • Regularly check the status of your application through BPOM’s online registration portal to ensure timely approval and address any issues that arise.

Summary of Pre-Registration Preparation Steps

1. Confirm Device Classification: Ensure your device qualifies as Class II under BPOM's regulations.
2. Designate an Authorized Representative in Indonesia (for foreign manufacturers).
3. Prepare the Required Documentation: Include business licenses, certificates (e.g., Free Sale, ISO), clinical data, product specifications, and labeling.
4. Review Product Labeling and IFU: Ensure compliance with Bahasa Indonesia requirements.
5. Obtain GMP Certification (if applicable) to confirm manufacturing compliance.
6. Complete and Review the Application Form: Ensure all fields are correctly filled out and supported with appropriate documents.
7. Establish Local Distribution Channels: Work with authorized distributors if needed.
8. Prepare for Inspections or Audits: Be ready for BPOM inspections if required.
9. Understand the Fees and Payment Process: Make the necessary payments and track receipts.
10. Plan for Post-Market Surveillance: Ensure ongoing monitoring and reporting of adverse events.

By following these preparatory steps, you can increase the likelihood of a smooth and successful Class II medical device registration process in Indonesia. Would you like help with any specific part of this preparation?

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