Renewal Frequency: Medical device registrations in Malaysia typically need to be renewed every five years. It is crucial to initiate the renewal process well before the expiration date to avoid any lapses in registration.

After applying for Class C medical device registration with the Malaysian Medical Device Authority (MDA), manufacturers must adhere to several regulations and requirements to ensure compliance throughout the registration process and post-registration.

Familiarize with MDA Guidelines: Review the latest MDA guidelines, regulations, and standards for medical devices to understand the requirements specific to Class C registration.

Monitoring and Reporting: Implement a post-market surveillance system to monitor the device's performance and safety in the market. This includes tracking adverse events, user feedback, and any product complaints.

This international standard specifies requirements for a quality management system (QMS) that demonstrates consistent design, development, production, and post-market processes for medical devices.

Device Overview: Provide a complete description of the device, including the device name, model, and intended use.

Completeness and Quality of Application: Incomplete or poorly organized applications can delay processing, as MDA may require additional documentation or clarification.

Confirm Device Classification: Verify that the device falls under Class C, which typically includes moderate- to high-risk devices such as surgical instruments, diagnostic imaging equipment, and some implantable devices. Use the MDA classification guidelines if needed to confirm.