Ensure ongoing compliance with the Medical Device Act 737 (2012) and Medical Device Regulations 2012. This includes adherence to quality management systems, safety standards, and labeling requirements.

Adhere to the Medical Device Act 737 (2012) and the Medical Device Regulations 2012, which govern the registration and oversight of medical devices in Malaysia.

Confirm that your device is correctly classified as Class B according to the MDA’s classification rules. Understanding the criteria for device classification is crucial.

Monitoring Device Performance: Implement a plan for ongoing monitoring of the device’s performance in the market. This includes collecting and analyzing data on adverse events, complaints, and user feedback.

Device Description: A comprehensive description of the device, including its intended use, indications, and any contraindications.

Timeframe: This can take anywhere from a few weeks to several months, depending on the availability of data and the thoroughness of documentation. This includes gathering the technical file, quality management system documentation, risk management reports, and clinical evaluation data.

Confirm that the device is accurately classified as Class B according to MDA guidelines. Class B devices are considered moderate-risk.

Ensure your device is classified as Class B according to the Medical Device Authority (MDA) guidelines.