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complete procedure to meet

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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Timely Annual Report to be Submitted by PIBOs-2

Introduction On 20th November 2023, the Central Pollution Control Board issued a directive alert extending the deadline for filing the Annual Report for FY 2022-23 on the Centralised Extended Producers Responsibility Portal...

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LEGAL IMPLICATIONS OF THE CDSCO LICENSE UPDATE FOR CLASS C AND CLASS D MEDICAL DEVICES

In a recent notice by the CDSCO, new licensing requirements have been introduced for Class C and Class D medical devices for all importers/manufacturers across India effective from the 1st of October...

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Manufacturing/import license for new Medical Devices

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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Wholesale Drug License

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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Manufacturing Class A-B Medical Devices: Who can apply, Forms, Fee, Validity, Timeline

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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Integrated Pharmaceutical Database Management System 2.0

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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Non-Sterile Medical Device Classification

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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Checklist and necessary documents to get Test License for Medical Devices to Import

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...

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