The US Food and Drug Administration (FDA) has proposed revisions to the de novo pathway in order to make medical device classification more efficient and transparent. The De Novo pathway is used to review new, low-to-moderate risk devices and determine predicates that assure certain safety and effectiveness measures.The regulatory agency has published the new de […]
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As members of Congress work to pass the last five appropriation bills before a December 7 deadline, they must not miss the opportunity to repeal a misguided, job-killing medical device tax that threatens growth and innovation in America’s health care industry. This tax was implemented in 2010 as part of the Affordable Care Act to
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Usability Testing : Usability testing is a process that involves testing how simple and safe a is. It is a requirement to test usability on medical devices to ensure that the device itself meets government standards.Factors that affect the usability of a product includes the following: time, resources, and efficiency. If an incident occurs during
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Food and Drug Administration’s modernization plan for its 510(k) Program may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner Scott Gottlieb and Jeffrey Shuren, director of the Center for Devices and Radiological Health, said that the agency is considering placing a 10-year limit on older predicates. In other
FDA Is Modernizing Its 510(k) Program, On How Old A Predicate Device Read More »
FDA 21 CFR Part 820 and ISO 13485: Over the course of more than 20 years in regulatory affairs and quality consistency, we’ve discovered how difficult it can be to implement a quality management framework that successfully enables effective product development while adhering to both domestic and international quality framework requirements. However, it is critical
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This is the most comprehensive guide for every manufacturer who wants to the medical device registration in different countries all around the globe.Let’s check QMS certification for different countries all over the globe which helps you to market your product globally.
Guide for Medical Device Regulations by Countries Read More »
If India’s drug regulatory authority’s plan bears fruition, users will soon be able to report injuries and other problems caused by medical devices through a mobile app. The app will also list safety information and notify users if a particular product has been recalled. The move comes in the backdrop of investigations by an 11-member
CDSCO plans app for complaint redressal : Medical Devices Read More »
Medical Device Registration in Thailand An Overview: Navigating the regulatory approval process for medical devices and in vitro diagnostics (IVDs) in Thailand is essential for successful market entry. This guide outlines the key steps, classifications, and requirements set by the Thai Food and Drug Administration (FDA) to help you understand and comply with local regulations.
Introduction to Medical Device Registration in Ireland: Ireland is an island in the North Atlantic. It is the island separated from Great Britain to its east by the North Channel, the Irish Sea, and St George’s Channel. Ireland is the third-largest island in Europe. Although Ireland’s economy is strong compared to its European neighbors, the
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Export of Medical Devices to India: An Overview Exporting medical devices to India has become increasingly lucrative in recent years due to the country’s reputation for producing high-quality healthcare products at competitive prices. The Indian medical device industry offers an extensive array of products, encompassing diagnostic equipment, surgical instruments, implants, hospital furniture, and more. Navigating
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