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China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to… Read More
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, and stages of product development. Read More
The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China. Read More
The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More
India’s regulation of marketing practices for devices currently falls under the broader Uniform Code for Pharma Marketing Practices, which was introduced in 2011. Read More
The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More
The lawmakers pointed to recent cyber attacks that highlighted the vulnerabilities and unpreparedness of the healthcare sector to “increasingly sophisticated and rapidly evolving cyber threats.” Read More