Understand Regulations: Familiarize yourself with the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. Review relevant standards such as ISO 13485 and ISO 14971.

Regulatory Compliance: Ensure ongoing compliance with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. Familiarize yourself with any updates or changes to these regulations that may impact your device.

Monitoring: Implement a system for post-market surveillance to monitor the performance and safety of the device once it is on the market. This includes collecting and analyzing data on device performance and user feedback.

Review Guidelines: Familiarize yourself with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. Understand the specific requirements for Class C medical devices.

Certificate: Upon approval, you will receive a registration certificate from the MDA. Ensure you keep this certificate accessible and display it as required, particularly if you are operating in Malaysia.

This is the principal legislation governing medical devices in Malaysia. It establishes the framework for regulating medical devices and includes provisions for device registration, compliance, and enforcement.

Device Description: Provide a detailed description of the device, including its intended use, design, components, and how it works. Include technical specifications, performance characteristics, and a clear depiction of the device’s purpose and functionality.

Document Preparation: Gathering and preparing all required documents, such as the Common Submission Dossier Template (CSDT), conformity assessment reports, and quality management system certifications, can take several weeks to months depending on the complexity of the device and the readiness of the documentation.