Asia
The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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...
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...
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...
