HSA
The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
Asia
This article highlights key steps and considerations for medical device companies to establish effective design controls. Table of Contents Design controls are a crucial aspect of the medical device development process.They ensure that medical devices are safe,...
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
HSA
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...
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...
