Class C medical devices are considered medium to high-risk devices that may have significant impact on the health and safety of patients. These devices generally support or sustain human life, and any malfunction or incorrect use could pose a higher level of risk compared to Class A or B devices. Examples of Class C devices include dialysis machines, diagnostic imaging equipment, and certain surgical instruments.

Class C medical devices in Malaysia are considered medium to high-risk. It's important to ensure that your product falls within this category according to the Medical Device Regulations 2012.

Quality Management System (QMS): Establishing and maintaining an ISO 13485-compliant QMS.

Continuous Monitoring: Manufacturers are required to implement a Post-Market Surveillance plan to monitor the performance of their devices once they are on the market.

High-Risk Devices: D-class medical devices are categorized as high-risk due to their potential impact on patient health. Registration ensures that these devices meet stringent safety and efficacy standards to protect patients from potential harm.

Quality Management System (QMS): Establishing and maintaining an ISO 13485-compliant QMS.

High Risk: These devices are considered to present the highest risk to patients and users due to their intended use, potential risks, or the complexity of their operation. They often include life-supporting or life-sustaining devices, high-risk implantable devices, or devices that are critical to maintaining patient health.

Device Classification: Verify that your device qualifies as a D-class medical device, which is a high-risk category as defined by the Medical Device Authority (MDA) of Malaysia.