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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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Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical fieldson 23 July 2021.

Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical...

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Drug Controller General of India (DCGI) classifies 55 medical devices pertaining to Dermatology and Plastic Surgery

The Central Drugs Standards Control Organization (CDSCO) has recently released a notification on 26th July 2021 for the classification of medical devices used in the Dermatological and Plastic Surgery under the provisions...

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DCGI enlists new regulation for the classification of Medical Devices pertaining to Anaesthesiology

The Drugs and Cosmetics Act, 1940, and Rules regulate the safety, quality, and performance of all medical devices. The Central Government has notified Medical Devices Rules, 2017 vide G.S.R. 78E dated January...

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Regulatory Updates on Disinfectants

Sanitizers can be of different variants, primarily based on active ingredients, such as soap containing natural fats, detergents, or alcohol-based (Table 1). The Centers for Disease Control and Prevention (CDC) recommends the...

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COVID-19 Home Testing using Rapid Antigen Tests (RATs)

Rapid Antigen tests (RATs) are commonly used to diagnose respiratory pathogens, including influenza virus and SARS-CoV-2 virus. These tests have come to practical use in the diagnosis of the infection in the...

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CDSCO provides guidelines for approval of COVID-19 Vaccines for restricted use in an emergency situation in India and for the import of vaccine by the private sector

Approval of COVID-19 vaccines for restricted use in India On the 15 th April, 2021, the National Expert Group on Vaccine Administration for the COVID-19 recommended the authorization for the emergency use...

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Extended timelines for submission of notarized/ apostilled documents for import and Registration of cosmetics

As the situation arising out of the Covid-19 pandemic is worsening further in the country, the Drugs Controller General of India (DCGI) has further extended deadline by four months to submit notarized...

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CDSCO Orders Regulation of CT Scan Equipment, All Implantable Devices, Medical Equipment As Drugs

Regulations for the import or manufacture of medical devices The Ministry of Health & Family Welfare, Government of India, has notified the list of equipment or devices which will be regulated as...

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