Asia
The article covers the general points related to the regulatory requirements for combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for...
Malaysia
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
Malaysia
The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare...
Malaysia
The new article describes in detail the aspects related to the roles and responsibilities of the entities engaged in operations with medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices,...
Malaysia
The new article highlights the aspects related to different changes to establishment license including, inter alia, changing or adding type of a license, making changes to the name of the entity or the address where the premises are located. The Medical Devices...
Malaysia
The new article describes in detail the aspects related to establishment licenses, as well as the requirements related to the licenses for retailers and tendering agents. The Malaysian Medical Devices Authority (MDA), a country’s regulatory agency in the sphere of...
