HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
Asia
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...
Asia
The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the...
Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
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