![FDA Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions](https://www.regdesk.co/wp-content/uploads/2021/10/Draft-Guidance-on-Electronic-Submission-Template-for-Medical-Device-510k-Submissions-1-1080x675.png)
Oct 7, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions. The document is...
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![HSA Guidance on Medical Device Registration: Basics](https://www.regdesk.co/wp-content/uploads/2021/09/singapore.jpg)
Sep 9, 2021
Africa
The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a detailed guidance document describing the most important aspects associated with the registration of medical devices in order for them to be...
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![Health Canada on Significant Changes: Guidance for Implementation](https://www.regdesk.co/wp-content/uploads/2021/08/canadian-parliament.jpeg)
Aug 4, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
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