The registration of Class B medical devices in Malaysia refers to the formal process of obtaining regulatory approval from the Medical Device Authority (MDA) to legally market and distribute a medical device classified as Class B within Malaysia.

Confirm that your device is classified as Class B (low-to-moderate risk) according to the Medical Device Authority (MDA) classification criteria.

The process for applying for the registration of Class B medical devices in Malaysia is regulated by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). The registration must be done through the MeDC@St (Medical Device Centralized Online System) portal.

Handling the registration of Class B medical devices in Malaysia involves a structured process governed by the Medical Device Authority (MDA), and it must be done through the MeDC@St system.

The time it takes to register a Class B medical device in Malaysia typically ranges from 3 to 6 months, depending on the completeness of the submitted documents and the complexity of the review process. The timeline can be extended if additional information or clarifications are required by the Medical Device Authority (MDA).

Registering Class B medical devices in Malaysia involves a structured process overseen by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). The process includes preparing necessary documents, complying with standards, and using the MeDC@St online system to submit your application. Here are the steps for registering a Class B medical device in Malaysia:

Periodic updates on standards and processes for Class B medical devices registration in Malaysia are typically issued by the Medical Device Authority (MDA), the governing body responsible for regulating medical devices in Malaysia. These updates can involve changes in regulatory requirements, international standards, post-market surveillance, and the use of technology platforms for application submission and tracking.

After applying for the registration of Class B medical devices in Malaysia, there are several regulations and requirements you must adhere to while waiting for approval, as well as once your device is registered. These obligations are designed to ensure ongoing compliance with the Medical Device Authority (MDA) and the safety of medical devices marketed in Malaysia.