Medical Device US FDA user fees were first settled in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were restored in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the FDA Safety and […]
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Overview of Disposable Syringe Manufacturing in India Disposable syringes are among the most widely used medical devices, ensuring safe and sterile administration of drugs and vaccines. With increasing healthcare awareness, rising immunization drives, and strict government regulations on safe injection practices, the syringe manufacturing industry in India is witnessing rapid growth. To manufacture syringes legally,
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FDA Drug Master File (DMF) Type III A Drug Master File (DMF) is a confidential submission to the U.S. Food and Drug Administration (FDA) that contains detailed information about the facilities, processes, and components used in the manufacturing, processing, packaging, and storage of human drugs. Although not mandatory under FDA regulations, submitting a DMF is
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There are thousands of Medical Devices being promoted and advertised out there. The U.S FDA Food And Drugs Administration has the legal power to regulate the advertising and promotion of limited medical devices that are not recognized by the FDA for the sale and distribution for their willful use. A limited Restricted device is a
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Medical Device Regulatory Consultation: In the healthcare community the medical device plays a crucial role by contributing new solutions that help in strengthening the patient condition. Every firm is on the edge of inventing something whether by repeated updates to already present technology or just by improving new devices that can indulge an effective treatment
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Introduction to Medical Device Contract Manufacturing Medical Device Contract Manufacturing is a type of subcontracting in which a company produces a entire product, a single part, or a larger product. This is well found in the medical device industry. Over the past 10 years the industry and the contract manufacturing sector have met a lot
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Medical device packaging is a critical aspect of getting the item to market safely and securely, while keeping the sterile barrier intact. Poor packaging can compromise the safety of both the medical devices and its users. If a box contains a sterile medical device, it must arrive at hospitals and clinics with no holes or
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Germany’s Medical Device Industry Germany’s medical device sector is the largest in Europe and the third largest in the world, taking up 10.2% of global medical tech production after the US (39.6%) and China (11.1%). In 2015 it reached €27.6bn in sales, €17.6bn of which was in exports. Germany has a robust regulatory framework for
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A validation master plan (VMP) diagrams the standards associated with the capability of an office, characterizing the areas and systems to be approved, and gives a composed program for achieving and keeping up a certified facility.
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Health Canada posted a new draft guidance document on Friday to aid medical device manufacturers in complying with premarket devices cybersecurity requirements. The move comes as more regulators seek to expand on considerations for the cybersecurity of medical devices as the health care sector became a prime target for cyberattacks amid an increasingly connected ecosystem.
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