Feb 9, 2023
Asia
The new article addresses the aspects related to reporting incidents associated with combination products allowed for marketing and use in Malaysia. Table Of Contents Incident Reporting: Key Points The document further highlights the key points associated with...
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Feb 7, 2023
Asia
The new article addresses the matters related to the applicable review timelines, fees payable, and changes to registered combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has...
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Feb 7, 2023
Asia
The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the...
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Feb 7, 2023
Asia
The article covers the general points related to the regulatory requirements for combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for...
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Dec 15, 2020
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to requesting FDA feedback on combination products. The document is intended to improve the clarity and transparency of the existing regulatory framework for combination products. Due to its legal...
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