For the registration of D-class medical devices with the Ministry of Health (MOH) in Indonesia, through the National Agency of Drug and Food Control (BPOM), the regulatory standards are aligned with international norms while also taking into account the specific requirements of the Indonesian regulatory framework.

D-class devices are categorized as low-risk medical devices, which generally have fewer regulatory requirements compared to higher-risk classes (Class II and Class III). However, they must still meet key safety, quality, and performance standards to ensure their effectiveness and safety for public use.

Here are the standards and regulatory requirements for registering D-class medical devices in Indonesia:

1. Indonesian Medical Device Regulations

• Regulatory Authority: The Indonesian Ministry of Health (MOH) and BPOM are responsible for overseeing the regulatory framework for medical devices in Indonesia.
• Relevant Regulations:
  • Regulation No. 62/2017 on Medical Device and Household Health Supplies: This regulation sets out the requirements for medical device registration, including classification, safety, performance standards, and labeling.
  • BPOM Regulation No. 26/2018 on Medical Device Registration: This regulation outlines the specific procedures for registering medical devices in Indonesia, including the classification of medical devices and the required documentation for registration.
  • BPOM Regulation No. 28/2021: This regulation specifically covers low-risk devices (including D-class devices), clarifying which devices are eligible for simplified registration procedures.

2. International Standards for Medical Devices

Indonesia’s medical device regulations are heavily influenced by international standards. Although D-class devices are considered low-risk, they still need to meet the following key international standards:

• ISO 13485:2016: Quality Management Systems for Medical Devices. While not always mandatory for low-risk devices, demonstrating compliance with ISO 13485 shows that the manufacturer follows internationally recognized best practices for device design, manufacturing, and post-market surveillance.

• ISO 14971: Risk Management for Medical Devices. D-class devices must have documented evidence of risk management, though they are considered low-risk. Manufacturers must assess potential hazards and ensure that risks are minimized.

• IEC 60601 series: Medical Electrical Equipment standards (if applicable). If the D-class device involves electrical components, it must comply with IEC 60601 for safety and essential performance. For instance, IEC 60601-1 deals with general safety requirements for medical electrical equipment, and IEC 60601-1-2 addresses electromagnetic compatibility (EMC).

• ISO 10993: Biocompatibility testing. For devices that come into contact with the body (such as medical devices used in diagnostics), ISO 10993 provides guidelines on biocompatibility testing to ensure that the materials used are safe for patient contact.

• ISO 15223-1: Symbols to be used with medical device labels. This standard is relevant for device labeling and ensures that symbols used on the product’s packaging and instructions are consistent with international norms.

3. Indonesian-Specific Requirements

While Indonesia follows many international standards, there are specific local requirements that need to be adhered to for medical device registration in the country:

• Indonesian Language Requirements: All medical device labeling and Instructions for Use (IFU) must be in Indonesian or accompanied by a certified translation. This is to ensure that Indonesian users (including healthcare professionals and patients) can properly understand and use the device.

• Local Authorized Representative: Foreign manufacturers must appoint a local authorized representative or distributor in Indonesia to manage the registration process. This representative must be registered with BPOM.

• Medical Device Registration Code: BPOM assigns a registration code to approved medical devices, which must be included in marketing and promotional materials in Indonesia. This code confirms that the device has been legally registered and approved for sale.

4. Standards for Risk Classification

Indonesia classifies medical devices into four classes based on the degree of risk:

• Class A (low risk): Non-invasive devices with minimal risk (e.g., bandages, thermometers).
• Class B (low to moderate risk): Devices that may have moderate risk, such as diagnostic equipment.
• Class C (moderate to high risk): Devices that have a higher risk, such as certain surgical instruments.
• Class D (high risk): High-risk devices that can pose significant harm to patients if not properly regulated (e.g., pacemakers, implantable devices).

D-class devices, being low-risk devices, typically require minimal clinical data to support their safety and effectiveness. They must be proven to:

• Meet international safety and performance standards, such as ISO 13485 and IEC 60601 (if applicable).
• Have minimal potential to cause harm to the patient or user under normal conditions of use.
• Comply with the Indonesian labeling and packaging regulations.

5. Simplified Registration Process

D-class medical devices, being low-risk, benefit from a simplified registration process under BPOM’s regulations. This process generally involves the submission of basic technical documentation (e.g., product description, Certificate of Free Sale (CFS), labeling) without the need for clinical trials or extensive safety testing.

6. Post-Market Surveillance and Vigilance

After the device is registered, manufacturers are required to comply with post-market surveillance (PMS) obligations, including:

• Reporting adverse events or device failures to BPOM.
• Ensuring that the device continues to meet safety and quality standards throughout its lifecycle.
• Engaging in corrective actions (e.g., recalls, repairs) if safety issues are identified post-market.

Summary of Key Standards for D-Class Device Registration:

1. Compliance with Indonesian Regulations:

   • BPOM regulations on medical device registration (Regulation No. 62/2017 and BPOM Regulation No. 26/2018).
   • Indonesian language requirements for labeling and instructions for use.

2. International Standards:

   • ISO 13485: Quality management systems for medical devices.
   • ISO 14971: Risk management for medical devices.
   • IEC 60601: Electrical safety standards (if applicable).
   • ISO 10993: Biocompatibility standards (if applicable).
   • ISO 15223-1: Symbols for medical device labels.

3. Local Requirements:

   • Local authorized representative/distributor (for foreign manufacturers).
   • Compliance with Indonesian labeling standards.

4. Post-Market Obligations:

   • Post-market surveillance and reporting of adverse events.

By ensuring compliance with these Indonesian regulations and international standards, you can facilitate the registration process for your D-class medical device in Indonesia.

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