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...
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Mar 22, 2023
Saudi Arabia
The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...
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Mar 14, 2023
FDA
The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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Mar 6, 2023
FDA
The new article addresses the aspects related to enforcement actions the authority may take, and also describes the various types of standards. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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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...
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