Asia
The new article addresses specific aspects regarding the Essential Principles medical devices should comply with to be allowed for marketing and use in Singapore. In particular, the article describes in detail the general requirements to be followed, and also the...
FDA
The article provides a brief overview of the applicable regulatory requirements for orthopedic fracture fixation plates. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
FDA
The new article provides the details regarding certain specific aspects associated with the quality system information to be provided by the medical device manufacturer applying for marketing approval. Table of Contents The Food and...
Asia
The new article describes in detail the Essential Principles to be taken into consideration concerning medical devices intended to be marketed and used in Singapore. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
FDA
The article provides a brief overview of the most important matters related to electronic medical device reporting. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
