Familiarize Yourself with Relevant Regulations: Review the Medical Device Act 2012 and its associated regulations to understand the legal requirements for device registration in Malaysia.

After obtaining approval for a B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), manufacturers should be aware of several important post-registration responsibilities and considerations to ensure continued compliance and successful market operation.

Quality Management Systems: This international standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Compliance with ISO 13485 is mandatory for manufacturers of medical devices in Malaysia.

General Description: Provide an overview of the device, including its name, model, intended use, target population, and operating principles.

The processing time for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) can vary based on several factors, including the completeness of the application, the complexity of the device, and MDA's current workload.

Classification Confirmation: Ensure that the device is classified as Class B according to MDA's classification guidelines. Class B IVDs are generally considered low to moderate risk devices. The classification is based on factors such as intended use, risk level, and how the device interacts with the body.

To apply for a B-class in vitro diagnostic (IVD) medical device registration with Malaysia’s Medical Device Authority (MDA), follow these steps. The application is processed entirely through MDA’s online platform, known as the Medical Device Information and Safety System (MeDISS).

For B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), specific materials and documentation are required to demonstrate compliance, safety, and performance of the device. Here’s a detailed list of required materials and a guide to preparing the application documents.