Confirm Classification: Ensure that the device is correctly classified as Class C according to the Medical Device Regulations 2012. Class C devices are considered medium to high risk, which dictates the level of scrutiny and requirements for registration.

For Non-Malaysian Manufacturers: Appoint a local Authorized Representative (AR) who is registered with the Medical Device Authority (MDA) in Malaysia. The AR will handle the registration process and act as the point of contact with the MDA.

Device Description: Provide detailed information about the device, including its design, intended use, functionality, and technical specifications.

Verify that your device falls under Class C according to the Medical Device Regulations 2012. Class C devices are considered medium to high risk and require a detailed review.

Website: Go to the MeDC@St system through the MDA’s online portal.

Registration Fees: The fees for registering a Class C medical device are generally higher than for lower-risk classes. As of the latest information, the registration fee for Class C devices can range from MYR 2,000 to MYR 6,000. This fee is subject to change, so it's best to check the latest fee structure on the MDA website.

Verify Classification: Ensure that your device is accurately classified as Class C based on its intended use and associated risks. This classification determines the regulatory requirements.

Determine the Device Class: Verify that your device is classified as Class C, which indicates a medium to high risk. This classification affects the registration process and requirements.