The processing time for Class A medical device registration with the Medical Device Authority (MDA) in Malaysia is generally shorter compared to higher-risk classes, due to the lower complexity and risks associated with these devices.

To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, certain conditions must be met to ensure compliance with the Medical Device Act 2012 and Medical Device Regulations 2012. These conditions are designed to guarantee the safety, quality, and performance of medical devices marketed in Malaysia.

To apply for Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, you must follow a structured process through the MeDC@St portal.

For Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, certain documentation is required to ensure compliance with Malaysia's Medical Device Act 2012 and Medical Device Regulations 2012. Below is a comprehensive list of the required documents and guidance on how to prepare them.

Confirm that the device is classified as Class A under the Malaysian Medical Device Regulations. Class A devices are typically low-risk products like non-invasive devices (e.g., bandages, stethoscopes, thermometers).

To apply for Class A medical device registration in Malaysia, you need to submit your application through the Medical Device Authority (MDA), specifically using the Medical Device Centralized Online Application System (MeDC@St). This is Malaysia's official online portal for medical device registration.

Application Fee: The MDA charges a registration fee, which varies depending on the device type and the applicant’s location (local vs. foreign). Generally, the fees for Class A devices are lower than those for higher-risk categories.

The manufacturer must have a valid ISO 13485 certification, which demonstrates compliance with quality management standards specific to medical devices.