Apr 13, 2023
Africa
The new article addresses the aspects related to specific rules for medical devices with a measuring function or the ones intended to be sterile. The document also describes the general approach to be followed when applying classification rules. Table of Contents The...
Read More
Apr 6, 2023
Africa
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...
Read More
Mar 30, 2023
Asia
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...
Read More
Mar 14, 2023
Asia
The article provides an overview of the regulatory requirements related to the content of special communications to be issued by medical device manufacturers in order to inform about the issues associated with the products they are responsible for. Table of Contents...
Read More
Mar 2, 2023
Asia
The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices allowed for marketing and use in Singapore. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in...
Read More