What standards apply for Class C medical device registration in Indonesia MOH?

When applying for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), the device must comply with a set of standards and regulations to ensure safety, performance, and quality. These standards primarily include international standards recognized by BPOM, Indonesian National Standards (SNI), and specific BPOM guidelines.

Here are the key standards that apply to the registration of Class C medical devices in Indonesia:

1. Indonesian National Standards (SNI)

The Indonesian National Standards (SNI) are the official technical regulations for products marketed in Indonesia, including medical devices. BPOM requires that certain medical devices comply with SNI standards to ensure safety and performance.
Some devices may need to meet specific SNI standards for their category (e.g., SNI for sterile medical devices, SNI for surgical instruments, SNI for in-vitro diagnostic devices). The relevant SNI standards will depend on the type and intended use of the device.
SNI Compliance is essential for meeting BPOM's regulatory requirements.

2. ISO Standards

BPOM follows several international standards, especially ISO standards, to ensure the quality, safety, and efficacy of medical devices. These include:

ISO 13485:2016 (Quality Management System for Medical Devices): This standard specifies the requirements for a quality management system (QMS) where an organization must demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements.
ISO 14971:2019 (Risk Management for Medical Devices): This standard provides the requirements for the risk management process throughout the lifecycle of the medical device. It is critical for evaluating and mitigating risks associated with the device’s design, manufacturing, and use.
ISO 10993 (Biocompatibility): This is a series of standards that focus on evaluating the biocompatibility of medical devices and their materials to ensure they are safe for use with human patients. These tests are critical for devices that come into contact with the human body (e.g., implants, catheters, etc.).
ISO 15197:2013 (In-vitro Diagnostic Devices - Blood Glucose Test Systems): For in-vitro diagnostic devices like glucose meters, BPOM will look for compliance with ISO standards related to accuracy and reliability of the diagnostic devices.
IEC 60601 (Medical Electrical Equipment): This series of standards is relevant for electrical and electronic medical devices. It covers safety and performance requirements, such as electrical safety, electromagnetic compatibility (EMC), and performance in clinical settings.
ISO 14155 (Clinical Investigation of Medical Devices): This standard is applicable if clinical trials are needed to support the safety and efficacy claims of the device. It outlines the requirements for clinical investigations and clinical trials of medical devices.

3. Good Manufacturing Practices (GMP)

GMP for Medical Devices: BPOM requires manufacturers to follow Good Manufacturing Practices (GMP) when producing medical devices. GMP ensures that medical devices are consistently produced and controlled according to quality standards.
Manufacturers must provide GMP certification as part of the registration process. The certification should be issued by the regulatory authority of the country where the device is manufactured (e.g., FDA, EMA, or other relevant bodies). The GMP certification is often a prerequisite for obtaining marketing authorization in Indonesia.

4. ISO 9001 (Quality Management Systems - General)

While ISO 9001 is not specifically targeted at medical devices, many medical device manufacturers follow this general quality management system standard to demonstrate their capability in ensuring product quality and customer satisfaction. Some Class C devices may be required to demonstrate compliance with ISO 9001 as part of the regulatory review.

5. BPOM Guidelines and Regulations

In addition to international standards, BPOM’s specific guidelines and regulatory requirements must be followed. These include:

BPOM Regulation No. 27 of 2017: This regulation provides the framework for the registration of medical devices and household health products in Indonesia. It defines the classifications of medical devices, including Class C, and outlines the registration procedures.
BPOM Circular Letters: BPOM regularly issues circular letters that provide updates or clarifications on regulatory requirements. These letters may address specific issues regarding testing, safety, or other regulatory matters.
Local SNI Standards: BPOM may require compliance with specific Indonesian National Standards (SNI) for particular types of medical devices. These can be checked on the official BSN (Indonesian National Standardization Agency) website.

6. Electromagnetic Compatibility (EMC)

IEC 60601-1-2 (EMC Requirements for Medical Devices): For medical electrical equipment, compliance with IEC 60601-1-2 ensures that the device does not interfere with other electronic devices and that it is resistant to electromagnetic interference.
Devices that use electrical components (e.g., diagnostic machines, surgical tools) must pass EMC testing to prove that they do not generate harmful interference or malfunction when exposed to electromagnetic fields.

7. Sterilization Standards (if applicable)

For sterile medical devices, standards related to sterilization must be met, including compliance with ISO 11135 (for ethylene oxide sterilization) and ISO 17665 (for steam sterilization). These standards outline the requirements for ensuring the sterility of medical devices, particularly for devices that are intended for single-use or invasive procedures.

Summary of Key Standards for Class C Medical Device Registration in Indonesia:

Indonesian National Standards (SNI) – applicable depending on the type of device.
ISO 13485 – Quality management systems for medical devices.
ISO 14971 – Risk management for medical devices.
ISO 10993 – Biocompatibility testing for devices in contact with the human body.
IEC 60601 – Electrical safety and performance for medical devices.
ISO 15197 – In-vitro diagnostic devices (if applicable).
ISO 14155 – Clinical trials and investigations for medical devices (if applicable).
Good Manufacturing Practices (GMP) – Ensures high-quality production.
ISO 9001 – General quality management system for medical device manufacturers.
EMC (IEC 60601-1-2) – Ensures electromagnetic compatibility for electrical medical devices.
Sterilization Standards – For sterile medical devices (if applicable).

Conclusion:

To successfully register a Class C medical device in Indonesia, manufacturers must ensure that their devices comply with local and international standards related to quality, safety, performance, and risk management. Meeting the relevant ISO standards, complying with SNI, and demonstrating adherence to GMP are key requirements for a smooth registration process with BPOM. The standards mentioned above will help ensure the device is safe for use and meets all regulatory expectations in Indonesia.

Let me know if you need any additional details or assistance with specific standards!