
MDA Guidance on Medical Device Grouping: Specific Aspects
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
The article provides a general overview of grouping requirements applicable in Malaysia.
The article provides a general overview of grouping requirements applicable in Malaysia.
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
The article provides an overview of the regulatory framework for sample collection.