The Central Drugs Standard Control Organization (CDSCO) oversees the registration of IVD in India. The number of IVD devices requiring complete technical documentation supporting their registration applications was significantly expanded by the new Medical Device Rules, 2017. Formerly, only the critical IVD devices needed registration,
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To know how to Apply for InVitro Diagnostic Import License, you can read this blog, which contains all the required information about IVD Import License. Let’s start with these two regulatory provisions: the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rule
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In India, Medical Devices are regulated by the Central Drugs Standard Control Organization (CDSCO). Only the Notified Medical Devices have been regulated until now (there are 37 in this list), mainly concentrated on implantable devices. The CDSCO published the Medical Device Rules, 2020, on February
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Those dealing with medical devices must understand the importance of medical device compliance in India. This will ensure the medical device’s safety and effectiveness for its intended deregulatory standards compliance, which is important regardless of the device’s complexity. All medical device manufacturers need to meet
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CDSCO has issued essential guidance on retention of import license in India. This process is coming into effect under the new rules, as the first round of import licenses issued will start to expire this year (after the 5-year validity period). The update includes essential
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Eager to know about the process of Extended Responsibility then here is your answer. EPR Annual Compliance is the set of legal responsibilities that producers, importers, and brand owners should complete to fulfill the end-of-life of their products, mainly concerning plastic waste. This guarantees that
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The Quality System Regulation, in short, QSR, is a set of standards and rules introduced by the authorities to ensure that medical device manufacturers are making safe and effective items that cannot harm humans. All companies are required to obtain Quality System Regulation Licenses to
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The Procedure to apply for InVitro Diagnostic import license is followed. Initially, evaluation of the product is to be done to ascertain whether it meets the basic norms needed to file an application for an import license as per the Medical Rule of 2017. The
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If you are willing to apply for an MD License in India then you must understand first which license you require. After understanding this you must collect all the documents required for medical device registration In India. For any registration of a medical device, you
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If you are dealing with a Class A medical device, then you must apply for Class A Medical Device Registration in India. Without this license, you are not allowed to sell in the Indian market. Class A indicates the low-risk devices. So, if you are
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