Asia
The new article highlights the aspects related to the application of the reliance approach in the context of marketing authorization for medical devices. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of...
Asia
The new article highlights the aspects related to the commencement of corrective actions and the appropriate notification requirements. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
Asia
The new article describes in detail the process of applying for importation approval for a medical device. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance...
Asia
The new article highlights the aspects related to approvals for clinical trials, as well as pharmacovigilance practices. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has...
Asia
The article describes the approach to be applied with respect to corrective actions to be taken in response to non-compliances identified. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
Asia
The new article highlights the aspects related to the conditions to be fulfilled for a reliance mechanism to be applied and also describes its key components. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the...
