Risk Classification of Medical Devices

Medical devices have risks ranging from low risk to high risk that can potentially cause serious injury, to permanent disability and even death. Therefore, medical devices used in health services must be ensured to be safe, quality, and beneficial. To ensure safety, quality, and benefits, each medical device must first go through a pre-market evaluation process. In accordance with the provisions of the Asean Medical Device Directive (AMDD), medical devices are classified based on the risks posed during the use of the medical device. Based on these risks, medical devices are divided into four classes as follows:

1. Class A poses low risk, for example Film viewer, surgical gloves, oxygen mask.
2. Class B poses low to moderate risk, for example blood pressure cuff, steam sterilizer.
3. Class C poses moderate to high risk, for example patient monitor, x-ray machine
4. Class D poses high risk, for example heart stent, pacemaker.

There are factors that influence the classification of medical devices. The classification of medical devices is influenced by the following factors:

• Length of contact time of the device with the body – Degree and place of entry into the body – Combination of medical devices
• Intended use as a diagnostic tool or for maintenance – Local effects on the systemic
• Mechanism of action in the body
• Biological effects on the body (if appropriate)
• Contact with injured skin (if appropriate)
• Ability of the device to be reused or not

The applicant for the distribution license must independently determine the risk class according to the type of product to be insured. If a medical device is designed to be used in combination with other medical devices, each of those devices must be classified separately. The Ministry of Health has developed a new feature called SIKLARA (https://siklara.kemkes.go.id/), which functions to independently identify the risks of medical devices according to the risk classification stipulated in AMDD. Currently, SIKLARA is still under development and primarily functions as a supplementary tool for classification.

Reference:

Permenkes No. 62 Tahun 2017

SIKLARA Guidebook