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.
RegDesk Regulatory Roundup
The article highlights the aspects related to the information to be included in the application an interested party should submit.
The new article describes in detail the approach to be applied with respect to applications for advertisement approval to be submitted by interested parties.
The article provides a brief overview of the Malaysian legal framework for advertising healthcare products.
MDA Guidance on Classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices: Overview
The document outlines the key points related to the applicable classification requirements for specific types of medical devices. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a...
The new article addresses the aspects related to reporting incidents associated with combination products allowed for marketing and use in Malaysia. Table Of Contents Incident Reporting: Key Points The document further highlights the key points associated with...