MDA Draft Guidance on Change Notification: Overview
The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use in Malaysia.
The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use 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 provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to be taken into consideration in this respect.
The article highlights the aspects related to the information to be included in the application an interested party should submit.