Legal Authorization: Registration allows manufacturers to legally market and sell their Class C medical devices in Malaysia, ensuring compliance with local regulations.

The duration of the Class C medical device registration process with the Malaysian Medical Device Authority (MDA) can vary based on several factors, including the complexity of the device, the completeness of the application, and the current workload of the MDA.

Class C medical device registration with the Malaysian Medical Device Authority (MDA) pertains to the regulatory framework governing the approval and registration of medical devices categorized as medium to high-risk. Understanding this classification is essential for manufacturers and stakeholders involved in the medical device industry in Malaysia.

Confirm Classification: Verify that your device falls under Class C, which generally includes medium to high-risk devices. This classification is based on the intended use and the level of risk associated with the device.

Device Classification: Confirm that your device is classified as Class C based on its intended use and risk profile.

Familiarize with the Legal Framework: Study the Medical Device Act 737 and the Medical Device Regulations (MDR) 2012 to understand the classification, registration, and compliance requirements for Class C devices.

The time it takes to apply for Class C medical device registration with the Malaysian Medical Device Authority (MDA) can vary based on several factors, including the complexity of the device, the completeness of the application, and the current workload of the MDA.

Understand Classification: Confirm that your device is correctly classified as Class C according to MDA's classification criteria based on the level of risk associated with its use.