While there is no formal annual review process, manufacturers are required to implement a post-market surveillance system to monitor the safety and performance of their devices once they are on the market. This involves collecting and analyzing data on adverse events, complaints, and user feedback.

Legal Compliance: Registration allows manufacturers to legally market their Class B medical devices in Malaysia, ensuring compliance with local regulations and laws.

Timeframe: This phase, where you gather and prepare all necessary documentation (technical file, risk management plans, quality management system documents, etc.), can take from a few weeks to several months. The time required depends on the complexity of the device and the completeness of the existing documentation.

Class B devices are considered to pose a moderate risk compared to Class A (low risk) devices and Class C and D (higher risk) devices. This classification is based on factors such as the device's intended use, the nature of the device, and the potential risks associated with its use.

Device Classification: Verify that your device is classified as Class B according to the Medical Device Authority (MDA) guidelines.

Familiarize yourself with the Medical Device Act 737 (2012) and the Medical Device Regulations 2012 to understand the legal framework and specific requirements for Class B devices.

Timeframe: This phase can take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of the documentation. It involves gathering all necessary technical documents, risk management plans, quality management system records, and clinical evaluation data.

Verify Classification: Ensure your device is correctly classified as Class B according to the MDA classification guidelines.