In Indonesia, the D-class medical device registration refers to the process through which low-risk medical devices are formally approved for sale and use in the Indonesian market by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). Medical devices in Indonesia are regulated based on their risk classification, which determines the level of regulatory scrutiny required.

D-Class Medical Device Registration:

D-class refers to low-risk medical devices that do not pose significant risks to the user. These devices typically have simple designs and low potential for harm. They require the least stringent level of regulatory oversight compared to higher-risk categories (such as Class C or Class B devices).

Key Characteristics of D-Class Medical Devices:

• Low-risk: Devices that are not invasive, do not come into contact with the human body in a way that could cause harm, or pose minimal risks.
• Simple design: The devices are generally straightforward, and their functionality or risk profile does not require extensive clinical testing or complex safety assessments.
• Examples: Non-sterile bandages, simple diagnostic tools, patient monitoring devices (e.g., thermometers, blood pressure cuffs), and basic medical instruments.

Why Register D-Class Medical Devices?

Medical devices, regardless of their risk classification, must be registered with BPOM before they can be marketed and sold in Indonesia. This ensures that:

1. Product safety: The device is safe for use by consumers and healthcare providers.
2. Regulatory compliance: The device meets local regulatory standards for manufacturing, quality, labeling, and documentation.
3. Market access: Approval from BPOM is a legal requirement for any device to be imported or sold in Indonesia.

Process Overview for D-Class Medical Device Registration:

For D-class medical devices, the registration process is typically less complicated than for higher-risk devices, but still involves several steps:

1. Verification of Device Classification: Ensure that the device qualifies as D-class by meeting the criteria for low-risk devices in Indonesia.
2. Prepare Required Documents: Submit essential documentation, including product information, manufacturer details, performance test reports, quality management certifications (like ISO 13485), labeling in the Indonesian language, and Certificate of Free Sale (CFS).
3. Submit Application via BPOM's e-Registration Portal: The device registration must be done online through BPOM's e-Registration system.
4. BPOM Review: BPOM will review the submitted documents, assess compliance with regulatory standards, and issue a registration certificate if the device is approved.
5. Post-market Surveillance: After registration, the device must comply with post-market surveillance requirements to monitor its safety and effectiveness in the market.

Key Considerations for D-Class Medical Device Registration:

• Low-risk nature: D-class devices are considered less complex and less dangerous, so the review process may be quicker compared to higher-class devices.
• Documents required: While less extensive than higher-risk categories, the application still requires technical documentation, performance data, and other regulatory certifications.
• Local Representation: Foreign manufacturers must appoint a local distributor or authorized representative in Indonesia to handle the registration and importation process.
• Regulatory Fees: BPOM charges registration fees, which vary depending on the device's classification and other factors.

Summary:

D-class medical device registration in Indonesia is the process of obtaining official approval from BPOM for low-risk medical devices to be sold and used in Indonesia. It involves submitting documentation to demonstrate the device's safety, effectiveness, and compliance with local regulations. The registration process is simpler and faster compared to higher-risk devices but still ensures that the device meets Indonesian regulatory standards before being marketed in the country.

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