For Class I medical device registration with the Indonesia Ministry of Health (MOH), through the BPOM (National Agency of Drug and Food Control), the device must meet a variety of regulatory standards to ensure that it is safe, effective, and compliant with Indonesian health and safety requirements. These standards are in line with both national regulations and international standards, providing a framework for the safety and performance of medical devices in Indonesia.

Key Standards for Class I Medical Device Registration with Indonesia MOH

1. Indonesian Medical Device Regulatory Framework (BPOM)

• The BPOM governs the registration, import, sale, and distribution of medical devices in Indonesia, ensuring they meet the country's standards.
• The registration process for Class I devices must comply with the Indonesia Health Ministry Regulation No. 62/2017 on Medical Devices and Household Health Products, which outlines the overall framework for medical device registration, quality control, and market surveillance.
• BPOM follows the Indonesian National Standard (SNI) and international standards to ensure the safety, performance, and quality of medical devices.

2. International Standards (ISO and IEC Standards)

For Class I devices, the manufacturer must ensure that the product complies with international safety and quality standards. Common standards include:

• ISO 13485:2016 (Quality Management Systems): This is the most widely recognized quality management standard for medical device manufacturing. Manufacturers should demonstrate compliance with ISO 13485, which outlines the requirements for a quality management system that ensures medical devices meet regulatory requirements and quality standards.

• ISO 10993 (Biological Evaluation of Medical Devices): If the device has direct or indirect contact with the body (e.g., skin, mucous membranes), it must meet ISO 10993 standards for biocompatibility testing. For Class I devices, this is generally limited to materials like gloves, bandages, or simple non-invasive tools.

• IEC 60601-1 (Medical Electrical Equipment – General Requirements for Safety): If the device includes electrical components (e.g., electrical thermometers, diagnostic equipment), it must meet the IEC 60601-1 standard for electrical safety and performance.

  • IEC 60601-1-2: If applicable, this standard focuses on electromagnetic compatibility (EMC) for medical electrical equipment, ensuring that devices do not interfere with other electronic devices.

• ISO 14971 (Risk Management for Medical Devices): This standard outlines the process for identifying, assessing, and controlling risks associated with the use of medical devices. Though more relevant for higher-risk classes, Class I manufacturers may need to provide basic risk assessments, especially if the device presents any potential risk to the user.

3. Indonesian National Standards (SNI)

• SNI (Standar Nasional Indonesia): The Indonesian government has adopted several SNI standards for medical devices, particularly for devices that are commonly used in the healthcare system. Some Class I devices, especially those that are invasive or used in direct contact with patients, may need to meet specific SNI standards in addition to international guidelines.
• BPOM will check if the product complies with the relevant SNI standards when processing the registration. For non-invasive devices, the regulatory requirements may be less strict, but the device should still conform to relevant SNI standards for safety and quality.

For example:

• SNI 01-3746-2002 for medical gloves.
• SNI 01-3471-1998 for bandages.

These standards ensure that the devices are tested for basic safety aspects, such as durability, biocompatibility, and cleanliness.

4. Labeling and Packaging Standards

• Labeling in Bahasa Indonesia: All medical devices sold in Indonesia must have labels and instructions for use in Bahasa Indonesia (the national language). BPOM requires that the labeling includes:

  • Product name and description.
  • Intended use.
  • Manufacturer's name, contact details, and country of origin.
  • Warnings and precautions.
  • Instructions for use, if applicable.
  • Expiry date (if applicable) and storage conditions.

• Packaging Standards: Devices must be packaged in a manner that ensures safety, particularly for sterile devices. BPOM requires that the packaging is tamper-evident and protects the device during shipping and storage. For sterile devices, packaging should ensure sterility until the point of use.

SNI also provides guidelines for the packaging and labeling of medical devices sold in Indonesia, ensuring that the device can be easily identified and safely handled.

5. Risk Classification Standards

• BPOM follows a risk-based classification system for medical devices, which is based on international guidelines such as the Global Harmonization Task Force (GHTF) and IMDRF (International Medical Device Regulators Forum) classification systems.
• Class I devices are categorized as low-risk devices that have a minimal potential risk to patients. They typically include non-invasive products like medical gloves, bandages, thermometers, and some simple diagnostic devices.

The regulatory framework for Class I devices in Indonesia requires manufacturers to provide basic safety documentation, such as risk assessments (where necessary) and product testing, to demonstrate that the device is safe for its intended use.

6. Post-Market Surveillance Standards

• BPOM requires manufacturers, through their local authorized representative (AR), to comply with post-market surveillance requirements to ensure the ongoing safety and effectiveness of medical devices after they have been sold in the market.
• Post-market monitoring includes:
  • Reporting any adverse events related to the device.
  • Conducting corrective actions if the device does not meet safety standards.
  • Participating in recall procedures if necessary.

Manufacturers must keep track of post-market performance, including any safety issues, and report them to BPOM as part of the pharmacovigilance activities.

Summary of Standards for Class I Medical Device Registration with BPOM:

1. Indonesian Regulations:

   • Follow Indonesia Health Ministry Regulation No. 62/2017 for medical device registration.
   • Compliance with BPOM's guidelines on safety, performance, and registration processes.

2. International Standards:

   • ISO 13485 for quality management systems.
   • ISO 10993 for biocompatibility (if applicable).
   • IEC 60601-1 for electrical safety (if applicable).
   • ISO 14971 for risk management (basic risk assessment may be required).

3. SNI (Indonesian National Standards):

   • Compliance with SNI standards for specific medical devices (e.g., gloves, bandages).

4. Labeling and Packaging:

   • Labeling in Bahasa Indonesia with required information.
   • Compliance with SNI packaging standards for tamper-evident, safe packaging.

5. Post-Market Surveillance:

   • Adherence to post-market surveillance requirements, including adverse event reporting and corrective actions.

Conclusion:

Class I medical devices must meet a combination of national and international standards to ensure their safety, performance, and quality. BPOM will evaluate the device's compliance with these standards during the registration process. Ensuring that the device meets the necessary regulatory, safety, and performance standards is essential to gaining approval for sale in Indonesia.

Contact Us：

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