RegDesk Regulatory Roundup

HSA on product registration submissions Asia

HSA on product registration submissions

The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...

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FDA on MDDT (special considerations) FDA

FDA on MDDT (special considerations)

The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

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