Before applying for B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM, thorough preparation is required to ensure that all necessary documentation, regulatory requirements, and processes are properly addressed. Here’s a detailed list of the key preparation work to be done:

1. Determine Device Classification

• Confirm Device Classification: Make sure that your device is classified as a B-class medical device. B-class devices are typically classified as moderate-risk devices according to BPOM's classification system. Review the classification rules or consult with a regulatory expert if needed to ensure that the device fits into this category.

2. Appoint an Authorized Representative (For Foreign Manufacturers)

• Local Authorized Representative: If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia who will handle all regulatory affairs on your behalf. This representative must be a legal entity in Indonesia, typically an importer or distributor registered with BPOM.
  • The authorized representative is responsible for submitting the application and ensuring compliance with Indonesian regulations.

3. Gather Required Documentation

Ensure you have the following documents ready before applying:

Manufacturer Documentation

• Manufacturing License: Ensure the manufacturing facility has a valid manufacturing license from the relevant authority in the home country.
• GMP Certification: If the manufacturer is located outside Indonesia, you will need to submit Good Manufacturing Practices (GMP) certification, ideally from an internationally recognized body (e.g., FDA, CE, WHO).
• ISO 13485 Certificate (if applicable): This is required to show that the manufacturer complies with the quality management system standards for medical devices.
• Free Sale Certificate (FSC): This document confirms that the device is legally sold in the country of origin, typically issued by the national regulatory authority.

Device and Technical Documentation

• Device Description and Intended Use: Prepare a detailed description of the device, including its intended use, functional specifications, and operational principles. Ensure that the device’s risk classification (B-class) is clearly explained.
• Clinical Evaluation and Performance Data: If applicable, provide clinical trial data or a clinical evaluation report to support the safety and efficacy of the device. For certain devices, BPOM may require evidence from clinical studies or post-market surveillance.
• Risk Management Report: Prepare a risk management report in compliance with ISO 14971, detailing the device's risk assessment and mitigation measures.
• Device Labeling and Instructions for Use (IFU): Prepare the device’s labels and instructions for use in Bahasa Indonesia. Ensure that the labels and IFU meet BPOM’s requirements, including proper warnings, precautions, and usage instructions.

Testing and Safety Compliance

• Safety and Performance Testing Reports: If applicable, submit reports demonstrating that the device complies with safety standards, such as:
  • Electrical safety (IEC 60601) for electrical medical devices.
  • Biocompatibility testing (ISO 10993) for devices that contact human tissue.
  • Sterility testing (if the device is sterile).
• Environmental Compliance: If applicable, ensure the device complies with relevant environmental regulations (e.g., RoHS, REACH).

Post-Market Surveillance Plan:

• If required, prepare a post-market surveillance plan that outlines how you will monitor the device’s safety and performance once it is on the market in Indonesia.

4. Translate Documents into Bahasa Indonesia

• Translation: BPOM requires that all documents, including instructions for use, labels, and product descriptions, be translated into Bahasa Indonesia. Ensure that these translations are accurate and meet regulatory standards.

5. Verify Device Registration History (if applicable)

• Check Existing Registrations: If the device is already registered or approved in other countries (such as FDA, CE, TGA, etc.), ensure that you have the necessary certificates (e.g., Certificate of Free Sale, CE Certificate) to include with your application.

6. Prepare a Detailed Device History and Technical File

• Technical File: Compile all the technical documentation into a technical file that includes:
  • Device design specifications.
  • Manufacturing processes and quality control procedures.
  • Testing and compliance data (e.g., biocompatibility, sterility, electrical safety).
  • Clinical data (if applicable).
  • Labeling, IFU, and packaging details.

Ensure the technical file is complete and easily accessible for BPOM’s review.

7. Prepare the Application Form and Registration Fee

• Complete the Application Form: Access BPOM’s e-Registration portal to fill out the required forms for medical device registration. The forms typically require detailed information about the device, manufacturer, intended use, and classification.
• Registration Fees: Be prepared to pay the registration fee. The fee can vary depending on the device type and complexity. BPOM provides a fee structure for medical device registration on their portal.

8. Develop a Post-Market Surveillance and Vigilance Plan

• Surveillance and Reporting Plan: BPOM requires that manufacturers monitor the device’s performance once it’s on the market. Prepare a post-market surveillance plan that outlines:
  • How adverse events will be monitored and reported.
  • Procedures for product recalls or corrections if necessary.
  • Collection and analysis of user feedback and complaints.

9. Establish Compliance with Indonesian Import and Distribution Requirements

• If the device is to be imported:
  • Importers must be registered with BPOM and meet regulatory requirements for medical device importation, including customs compliance.
  • Ensure that devices are handled and stored according to BPOM regulations and guidelines.

10. Prepare for Potential BPOM Inspections

• Facility Inspection: If BPOM requests an inspection of the manufacturing facility (especially if the manufacturer is located outside of Indonesia), be prepared for a thorough audit of the manufacturing process, quality control systems, and overall compliance with GMP.

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