Jul 19, 2021
FDA
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...
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Jun 9, 2021
Saudi Arabia
The Saudi Food and Drug Administration (SFDA), the country’s regulating authority in the sphere of healthcare products, has published updated guidance on approval requirements for medical device advertising. The document is intended to provide additional...
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Apr 28, 2021
Uncategorized
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published guidance dedicated to the labeling requirements medical devices should comply with in order to be allowed for marketing and use. Regulatory...
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Feb 13, 2021
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s agency responsible for the assessment of quality and safety of medical devices, has published an official notice describing the updated rules on a temporary suspension of...
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Feb 13, 2021
Australia and Oceania
The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made...
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