Confirm that your device is classified as Class C. This classification typically includes devices that present moderate to high risks, such as surgical instruments, diagnostic imaging equipment, and implantable devices.

Class C medical devices in Malaysia are categorized as those that pose a moderate to high risk to patients and users. This classification typically includes devices such as surgical instruments, diagnostic imaging devices, and certain implantable devices. Registration of Class C medical devices with the Malaysian Medical Device Authority (MDA) ensures that they meet safety, effectiveness, and quality standards before being marketed in Malaysia.

Class C medical devices in Malaysia are categorized as those that pose a moderate to high risk to patients and users. This classification typically includes devices such as surgical instruments, diagnostic imaging devices, and certain implantable devices. Registration of Class C medical devices with the Malaysian Medical Device Authority (MDA) ensures that they meet safety, effectiveness, and quality standards before being marketed in Malaysia.

Confirm that your device falls under Class C by referring to the MDA classification guidelines.

MDA reviews the application for completeness to ensure all required documents are included. Incomplete applications may lead to delays if MDA requests additional documents or clarifications.

Manufacturers must have a post-market surveillance system to monitor the safety and performance of the device after it enters the market. This includes tracking adverse events, complaints, and any field safety corrective actions (FSCAs) that may be necessary.

The purpose of processing B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) is to ensure that the device meets the country’s regulatory standards for safety, quality, and performance before it can be legally marketed and used within Malaysia. This regulatory process is essential for safeguarding public health and maintaining high standards in the medical device industry.

Completeness of Application: If all required documentation is submitted accurately, the review may proceed faster. Missing or incomplete documents can lead to delays.