IV Cannula Manufacturing: An Overview IV cannulas are essential medical devices used to deliver medications, fluids, or nutrients directly into the bloodstream. They consist of a small plastic tube (cannula) inserted into a vein, with one end having a valve for administering substances. The manufacturing process involves various steps, including insertion, sterilization, and quality control […]
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Overview of Disposable Syringe Manufacturing and Regulatory Requirements The manufacturing of disposable syringes is one of the most promising segments in India’s growing medical device industry. With the rising demand for safe, sterile, and single-use medical products, manufacturers are increasingly investing in advanced production technologies and compliant facilities. To legally manufacture disposable syringes in India,
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In recent years, India’s medical device regulations have become more complex. Previously, many devices didn’t require approval, but today, approximately 30 device “families” specify which devices must be registered. India’s medical device market offers opportunities for global manufacturers, as most devices are imported. Growth in this industry is driven by low per capita spending on
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India Approval Process for Medical Devices has been a very eye catching topic. The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline
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US FDA publishes FAQs and has announced the availability of temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections during COVID-19 Public Health Emergency Questions and Answers. It is recognized that the COVID-19 public health emergency is not only impacting public health, but also drug development programs, ongoing manufacturing operations
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The CDSCO responds to COVID-19(CDSCO) has granted approval for the emergency use of ‘remdesivir’ to treat novel Coronavirus disease (COVID-19) patients. However, the Union Ministry of Health and Family Welfare (MoHFW), in a conference on June 2, 2020, could not share details of the evidence on the basis of which this authorization was granted. The CDSCO responds
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Overview Of EU MDR checklist – Effects On Medical Devices EU MDR checklist The European Medical Device Regulation establishes minimum safety and quality requirements for medical devices made or imported into Europe. It underwent significant changes in 2017 to promote transparency through standard data, technological advancements, and the establishment of an EU (EUDAMED) database. While
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Personal Protective Equipment EUAs alludes to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment intended to protect the wearer from injury or the spread of contamination or ailment. To help address worries about accessibility during the COVID-19 pandemic, the FDA has given EUAs for certain PPE products including face shields, different obstructions,
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Key Aspects of Clinical Evaluation Reports (CERS) in Devices: A Clinical examination Report (CER) documents the findings from a clinical examination of your medical product. A CER is made up of evaluated clinical data acquired either from a clinical investigation of your product or the results of multiple investigations on significantly similar devices. The CER
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If you are looking for FDA medical device approval process for your medical device then you are at the right place. Medical devices, from ideation to post-launch assessment, are directed in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 an ensuing revision to the
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