To apply for B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM (Badan Pengawas Obat dan Makanan), you need to meet certain requirements and submit specific documentation as part of the application process. B-class devices are considered to have moderate risk and require a detailed review to ensure compliance with safety and performance standards.

Requirements for Applying for B-Class Medical Device Registration in Indonesia:

1. Classification of the Device

• Device Classification: Ensure that your device qualifies as a B-class medical device under Indonesian regulatory guidelines. B-class devices are typically moderate risk devices, meaning they have a potential for moderate impact on patient safety or health.
• Risk-based Classification: BPOM uses a classification system based on the risk the device poses to patients, such as the intended use, duration of contact with the body, and degree of invasiveness.

2. Authorized Representative (for Foreign Manufacturers)

• Local Representation: If you are a foreign manufacturer, you must appoint an authorized local representative in Indonesia to handle the registration process.
  • The local representative must be registered with BPOM and authorized to act on your behalf.
  • They will be responsible for ensuring compliance with BPOM regulations, submitting the application, and liaising with BPOM during the review process.

3. Product Documentation

You must prepare and submit the following key documentation for the B-class medical device registration:

a. Product Information

• Description of the Device: A detailed description of the device, including its name, model, intended use, and how it functions.
• Indications for Use: Clearly state what the device is intended to treat, diagnose, or assist with.
• Device Classification Justification: A document that justifies the B-class classification, which will explain the risk level of the device based on its intended use.

b. Manufacturing License

• Provide a manufacturing license or certificate showing that the device is made in a licensed manufacturing facility. This can be from the domestic or foreign regulatory authority where the device is manufactured.

c. Free Sale Certificate

• Submit a Free Sale Certificate (FSC) from the regulatory authority of the country of origin, confirming that the device is legally marketed and freely sold in that market.

d. Clinical Evaluation and Performance Data

• Clinical Data: For certain B-class devices, BPOM may require clinical evaluation or performance testing data to demonstrate safety and efficacy. This is typically needed for devices that are invasive or used for critical medical purposes.
• Risk Assessment: Include a risk analysis or risk management document to show that the device meets international safety and performance standards (e.g., ISO 14971).

e. Product Labeling and Instructions for Use

• Labeling: The device label must include all necessary information, including the device name, manufacturer's information, and safety precautions. Labels must be in Indonesian (Bahasa Indonesia).
• Instructions for Use (IFU): These must be clear and detailed, including usage instructions, safety guidelines, contraindications, and maintenance procedures.

f. Quality System Documentation

• Proof that the manufacturer adheres to an internationally recognized quality management system, such as ISO 13485 (for medical devices). This ensures that the manufacturing process meets high standards of safety and quality.

g. Certificates of Conformity (if applicable)

• If applicable, provide a Certificate of Conformity (CoC) or other documents that verify compliance with international standards like CE marking (for European markets) or FDA approval (for the US market).

4. Application Form

• Complete the registration application form provided by BPOM’s online e-Registration system.
• Ensure that all required information is filled out correctly, including device details, manufacturer information, and the local authorized representative’s contact details.

5. Local Testing or Inspection (If Required)

• Depending on the nature of the device, BPOM may request local performance testing or inspection.
  • Clinical or Laboratory Testing: Some B-class devices might require clinical trials or laboratory testing in Indonesia or by accredited international testing bodies.
  • Manufacturing Facility Inspection: In some cases, BPOM may conduct inspections of the manufacturing facility to verify that it meets regulatory standards.

6. Fees for Registration

• BPOM charges a registration fee for medical devices, which varies depending on the type and complexity of the device.
• Be prepared to pay the appropriate fees when submitting the registration application.

7. Documentation Verification and Translation

• All documents must be in English (or the original language of the country of origin) with certified translations into Indonesian.
• BPOM requires that the instructions for use and labeling be in Indonesian (Bahasa Indonesia).
• Ensure that all documents submitted are accurate, complete, and comply with BPOM's format and content requirements.

8. Post-Market Surveillance and Compliance

• After receiving registration approval, you are responsible for complying with post-market surveillance (PMS) requirements set by BPOM.
  • Report any adverse events related to the device.
  • Maintain records for inspection and provide periodic updates on device performance and safety.

Key Considerations for B-Class Medical Device Registration in Indonesia:

• Language Requirements: All documentation, including product labels, user manuals, and instructions for use, must be provided in Bahasa Indonesia.
• Local Representation: For foreign manufacturers, appointing a local representative is highly recommended to navigate the registration process smoothly.
• Risk Management: You must demonstrate that the device complies with safety and risk management standards to ensure patient safety.
• Regulatory Updates: Stay updated on regulatory changes in Indonesia, as BPOM periodically revises its medical device regulations.

By fulfilling these requirements, you can successfully submit your B-class medical device for registration with BPOM and ensure compliance with Indonesian regulatory standards for marketing and distribution.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn