![MHRA Guidance on Stand-Alone Software: General and Design-Specific Essential Requirements](https://www.regdesk.co/wp-content/uploads/2023/05/1-MHRA-Guidance-on-Stand-Alone-Software-General-and-Design-Specific-Essential-Requirements.png)
Jun 12, 2023
Europe
The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom. Table of Contents The...
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![MHRA Guidance on Stand-alone Software: Overview](https://www.regdesk.co/wp-content/uploads/2023/05/1-MHRA-Guidance-on-Stand-alone-Software-Overview.png)
Jun 12, 2023
Europe
The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices. Table of Contents The Medicines & Healthcare Products Regulatory Agency (MHRA),...
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![FDA Guidance on Soft Daily Wear Contact Lenses: Regulatory Approach in Detail](https://www.regdesk.co/wp-content/uploads/2023/05/1-FDA-Guidance-on-Daily-Wear-Contact-Lenses-Overview.png)
Jun 12, 2023
FDA
The article describes in detail the regulatory approach to be applied with respect to contact lenses allowed for marketing and use in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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![FDA Guidance on Daily Wear Contact Lenses: Overview](https://www.regdesk.co/wp-content/uploads/2023/05/1-FDA-Guidance-on-Soft-Daily-Wear-Contact-Lenses-Regulatory-Approach-in-Detail.png)
Jun 12, 2023
FDA
The new article highlights the aspects related to specific tests to be conducted by medical device manufacturers in order to demonstrate compliance with the applicable regulatory requirements. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
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![SFDA Guidance on Changes to MDMA: Materials](https://www.regdesk.co/wp-content/uploads/2023/05/1-SFDA-Guidance-on-Changes-to-MDMA-Materials.png)
Jun 12, 2023
Saudi Arabia
The new article highlights the key points related to the regulatory requirements associated with changes to the materials used in medical devices. Also, it outlines the scope of information to be included in the medical device change form to be submitted by the...
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