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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The new draft bill consists of a few new definitions such as clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability, investigational new drugs, imported spurious drugs, predicate devices and...
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Class B Medical Devices / In-Vitro Diagnostic Kits Class B medical devices have low to moderate risk to the patients and public health risks. Class B medical devices’ permissions or approvals are...
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Manufacturing And Product Development Support for Medical Devices / In-Vitro Diagnostic Kit The medical device industry of India is a crucial and integral part of the Indian healthcare industry. It provides preventative,...
Regulatory Update
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The Ministry of Health and Family Welfare (Department of Health and Family Welfare) under the Government of India, on 18th January 2022, G.S.R.78 (E) released an official gazette with a few new...
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Class A Medical Devices / IVDs – Class A medical devices / IVDs are medical equipment that has low risk to the patients and public health risks. Class A medical devices /...
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In the year 2017, the government of India announced that all the medical devices in India would be regulated as per Medical Device Rules-2017 (MDR-17), which gives a clear idea about the...
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What Is A Medical Device Authorized Agent / Representative? To register/sell a medical device in India, a Foreign Manufacturer must grant a Power of Attorney to a person/company in India who is...