SFDA Guidance on In-House IVDs: Intended Use and Risks
RegDesk | Medical Device and Pharma Regulations Blog
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6d ago
The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices ..read more
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SFDA Guidance on In-House IVDs: Overview
RegDesk | Medical Device and Pharma Regulations Blog
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6d ago
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs ..read more
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SFDA Guidance on Surgical Sutures: Overview
RegDesk | Medical Device and Pharma Regulations Blog
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6d ago
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia ..read more
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HSA Guidance on Medical Device Product Registration: Specific Aspects
RegDesk | Medical Device and Pharma Regulations Blog
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6d ago
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework ..read more
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MDCG Guidance on Qualification and Classification of Annex XVI Products: Overview and Qualification
RegDesk | Medical Device and Pharma Regulations Blog
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6d ago
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification ..read more
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MDCG Guidance on Content of Clinical Investigation Plan: Specific Aspects
RegDesk | Medical Device and Pharma Regulations Blog
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2w ago
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study ..read more
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Health Canada Guidance on Management of Medical Device Applications: Overview
RegDesk | Medical Device and Pharma Regulations Blog
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2w ago
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market ..read more
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DRAP Guidelines on Recalls of Defective Products: Overview
RegDesk | Medical Device and Pharma Regulations Blog
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3w ago
The article provides a general overview of the regulatory requirements for recall procedures for healthcare products intended to be marketed and used in Pakistan ..read more
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Health Canada Guidance on Medical Device Recalls: Reporting and Terminology
RegDesk | Medical Device and Pharma Regulations Blog
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3w ago
The new article clarifies the reporting requirements associated with medical device recalls and explains the key terms and concepts used in this respect ..read more
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Health Canada Guidance on Medical Device Recalls: Process Explained
RegDesk | Medical Device and Pharma Regulations Blog
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3w ago
The new article describes in detail the recall process, highlighting the most important aspects associated with it ..read more
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