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Regulation/Guidelines

DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining Of Physical Support

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to Physical Support based on the device’s intended use and risk and other parameters.

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Regulation/Guidelines

Regulatory Updates on Disinfectants

Alcohol-based hand sanitizers (gel) and hand rubs (liquid) together referred to as “ABHR’s”are simple formulations used to disinfect mainly the hands and get rid of bacteria, viruses, fungi etc. to prevent further transmission.A good sanitizer should destroy 99.99% microbes in ~20-30 seconds4,5 should be safe on skin over long-term use and optionally have a light non-overpowering fragrance.

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Regulation/Guidelines

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

Rapid Antigen tests aim to confirm positive test results of covid-19 infection in people possessing potential symptoms related to the disease. The rapid antigen home tests are accessible as they can be used wherever the patient is and can provide the test results quickly.

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Regulation/Guidelines

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

The Government of India has laid out guidelines for the Restricted use of vaccines in Emergency situations. The guidelines also allow the ready-to-use vaccine to be fully utilized from 1st May.

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Regulation/Guidelines

Extended Timelines For Submission Of Notarized/ Apostilled Documents For Import And Registration Of Cosmetics

Drugs Controller General of India (DCGI) has further extended the deadline by four months to submit notarized or apostilled regulatory documents for import and registration of cosmetics such as Authorisation from Manufacturer, free sale certificate (FSC) with legal signatures. This is in continuation to the notices given on April 20, 2020, August 19, 2020, and December 18, 2020.

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Regulation/Guidelines

CDSCO Recently Classified 80 In-Vitro Diagnostic Medical Devices For Regulation And Patient Safety

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.

Regulation/Guidelines

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 of Medical Device Rules (MDR) 2017.

Regulation/Guidelines

DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining To Anesthesiology

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to anaesthesiology based on the device’s intended use and risk and other parameters.

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