Mar 22, 2023
Thailand
The new article highlights the aspects related to management review, as well as the requirements for personnel, premises, and cleanliness as set forth by the draft regulation on criteria and good methods for distributing medical devices. Table of Contents The Thai...
Read More
Mar 6, 2023
Thailand
The article provides an overview of the draft law dedicated to the quality system for medical devices intended to be marketed and used in Thailand. Table of Contents Thailand’s regulatory authority in the sphere of healthcare products has published a document...
Read More
Jun 1, 2022
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...
Read More
Apr 28, 2022
FDA
The new article addresses the aspects related to the manufacturing information the authority expects to be included in the submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Read More
Apr 22, 2022
FDA
The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. Table of Contents The Food and Drug Administration...
Read More