How are devices classified?
Indonesia's medical device and IVD classification scheme is largely informed by the Global Harmonization Task Force (GHTF) and Association of Southeast Asian Nations (ASEAN) frameworks. The scheme combines concepts from both frameworks to classify devices and IVDs according to their risk level from low to high: Class A, Class B, Class C & Class D.
If your device is higher risk and more complex, you can expect more documentation requirements to support the clinical data, testing, and validation requirements necessary to demonstrate your device’s safety and effectiveness. Labeling and IFU requirements also expand for higher risk devices.
Indonesia medical device classification tiers
Medical devices and IVDs are classified into four tiers:
- Class A, low risk level to user, patient, or public (e.g., band-aids and examination gloves).
- Class B, moderate risk level to user, patient, or public (e.g., blood pressure monitors and thermometers).
- Class C, moderate-high risk level user, patient, or public (e.g., electrosurgical instruments and catheters); and
- Class D, high risk level to user, patient, or public (e.g., pacemakers and joint replacements).
Medical device grouping in Indonesia
Medical devices can be grouped in one application for registration. In general, grouping principles include:
- Same intended use;
- Used in combination to achieve intended use; or
- Similarity in products to simplify distribution permits.
There are several different grouping categories with specific grouping requirements. For instance, grouping requirements for a family of devices that are similar in their intended use are different than for a system of devices, which are intended to be used together. It’s important to consider different labeling and IFU requirements that apply to different grouping categories.
