The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
The document highlights the key points related to the current classification rules for different types of medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a...
The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
The article highlights the aspects related to the regulatory status of the changes related to medical devices allowed for marketing and use in the country. Table of Contents The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of...
The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare...