In Indonesia, the classification of medical devices follows a risk-based categorization system defined by the Ministry of Health (MOH) and managed by the National Agency of Drug and Food Control (BPOM). These categories are used to determine the regulatory requirements and the level of scrutiny a medical device will undergo during the registration process. Class C refers to moderate-risk medical devices in this classification system.

Meaning of Class C Medical Device Registration in Indonesia:

Class C medical devices are considered moderate-risk products, meaning they have a higher potential to cause harm to users compared to Class A (low-risk) or Class B (low-to-moderate risk) devices, but not as high as Class D (high-risk) devices. These devices typically require more comprehensive documentation and regulatory review than lower-risk devices.

Key Characteristics of Class C Medical Devices:

• Risk Level: Class C devices are moderate-risk, meaning they are usually used for more critical functions than Class A or B devices, but their potential risk to patients or users is lower than that of Class D devices.
• Examples of Class C Devices: This category often includes diagnostic equipment, therapeutic devices, surgical instruments, monitoring equipment, and other medical tools that require substantial regulation to ensure safety and effectiveness. For instance:
  • Diagnostic imaging equipment (e.g., X-rays, CT scans).
  • Therapeutic devices (e.g., infusion pumps, dialysis machines).
  • Surgical instruments (e.g., scalpels, electrosurgical units).

Regulatory Requirements for Class C Devices in Indonesia:

• Documentation: Class C devices must submit a comprehensive set of documentation for registration, including but not limited to:

  • Device description: Detailed technical specifications, intended use, and operational information.
  • Clinical Data: Depending on the nature of the device, clinical data may be required to demonstrate the device's safety and effectiveness.
  • Risk Management: Documentation must comply with international risk management standards (e.g., ISO 14971).
  • Quality Management System (QMS): Proof of compliance with ISO 13485, demonstrating that the manufacturer follows robust quality management practices during production.
  • Good Manufacturing Practice (GMP): Evidence that the manufacturer complies with GMP, which can be certified by recognized authorities like FDA (USA), EMA (Europe), or other regulatory bodies.

• Regulatory Review Process: The application for Class C devices goes through a detailed regulatory review process conducted by BPOM, which evaluates the safety, performance, and manufacturing processes of the device. The review may also involve an inspection of the manufacturing facility (if outside Indonesia).

• Approval and Certification: If BPOM is satisfied with the provided documentation and evaluation, they will issue a Marketing Authorization (NOM) and a Registration Certificate for the device, which allows the device to be legally sold and distributed in Indonesia.

Importance of Class C Registration:

• Patient Safety: Since Class C devices are moderate-risk, their registration ensures that the products meet the required standards of safety and performance before being allowed into the Indonesian market.
• Market Access: Registration provides access to the Indonesian market, which is one of the largest in Southeast Asia, allowing companies to legally sell and distribute their medical devices in the country.
• Regulatory Compliance: Successfully registering a Class C medical device ensures compliance with Indonesian medical device regulations and international standards, reducing legal risks and ensuring product quality.

In summary, Class C medical device registration in Indonesia means that the device is considered to carry a moderate risk to health or safety, and as such, it must undergo a regulatory review process that includes a thorough evaluation of the device’s technical, clinical, and quality assurance documentation. This ensures that the device meets the required standards of safety and effectiveness before it can be marketed in Indonesia.