Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices
Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
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Regulatory Update
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When anyone decides to get manufacturing/import license for new medical devices in India, the predicate device is first to check. If there is a predicate device, it works on substantial equivalence; if...
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As per the rules put down by the Drugs and Cosmetics Rules, a wholesaler who wishes to sell, exhibit, store, or distribute drugs in India must have a wholesale drug license. The...
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What are Class A-B Medical Devices? A medical device is a product that can be used alone or in combination with another products to diagnose, relieve, treat, or prevent diseases in humans...
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IPDMS 2.0 And Pharma SahiDaam 2.0 Application Launch NPPA just launched IPDMS 2.0 portal and as well as the Pharma Sahidaam 2.0 Application for the price regulation of drugs and medical devices...
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CDSCO Announces Non-Sterile Medical Device Classification Non-sterile and invasive medical tools commonly used for dissecting, cutting, sawing, drilling, grasping, clamping, clipping, retracting and similar procedures that require no electrical connection to activate...
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Test License for Medical Devices to Import An importer or manufacturer who wishes to import Class A, Class B, Class C, or Class D medical devices to India can apply for a...