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.

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.