Familiarize yourself with the Medical Device Act 2012 and related regulations, including the Medical Device Regulations 2012, to understand the legal requirements for registration.

Continue to comply with all applicable regulations and standards, including ISO 13485 and other relevant guidelines.

Quality Management Systems: This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

A comprehensive description of the device, including its intended use, indications, and any relevant specifications or standards.

Duration: Varies based on the complexity of the device and the completeness of the documentation.

Confirm that your device is classified as Class D, which is reserved for high-risk medical devices.

Ensure that your device is correctly classified as Class D based on MDA classification criteria.

Complete the online application form available on the MDA's e-Register platform.