CDSCO

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The Knowledge Corner
Drugs License
Shivam Narwal
| Updated: Mar 17, 2023 | Category: CDSCO

CDSCO Drugs License Eligibility and Requirements

The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for approving drugs for human and veterinary use. The CDSCO issues licenses to pharmaceutical companies, drug...

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Clinical Investigation
Shivam Narwal
| Updated: Mar 15, 2023 | Category: CDSCO

Step-by-Step Guide to Clinical Investigation under MDR, 2017

Medical devices are an essential part of the healthcare industry, and they play a critical role in the diagnosis, treatment, and prevention of various diseases and conditions. In India, the...

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Medical Devices
Shivam Narwal
| Updated: Mar 14, 2023 | Category: CDSCO

Application Procedure for Class C and D Medical Devices

Medical devices are an essential part of the healthcare industry, as they help in diagnosis, treatment, and monitoring of various medical conditions. In India, the Central Drugs Standard Control Organization...

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MEDICAL DEVICE RULES 2017
Shivam Narwal
| Updated: Mar 09, 2023 | Category: CDSCO

Medical Device Rules 2017- A Comprehensive Study

Medical devices play a crucial role in modern healthcare. They help diagnose, treat, and monitor diseases and medical conditions. Medical device regulations ensure that all medical devices are safe and...

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Form MD-4 and Form MD-6
Sherin Jose
| Updated: Dec 01, 2022 | Category: CDSCO

What is Form MD-4 and Form MD-6?

The Medical Devices Rules, 2017 were notified by the Ministry of Health and Welfare to put in place certain standards to regulate the use of medical devices and to ensure...

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Form MD-7 and Form MD-9
Karan Singh
| Updated: Nov 02, 2022 | Category: CDSCO

What is the Meaning of FORM MD-7 and FORM MD-9?

A person or a company involved in the manufacturing of Medical Devices in India can distribute/communicate the products by applying through the concerned Authority. The application process includes applying for...

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Exemptions of Cosmetics
Karan Singh
| Updated: Oct 29, 2022 | Category: CDSCO

What are the Exemptions of Cosmetics under Cosmetics Rules, 2020?

As per the Drugs & Cosmetics Act, 1940 and Cosmetics Rules, 2020, enacted thereunder, the State Drug Control Department inspects & grants Cosmetic License approval for manufacturers & importers in...

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Test License for Import
Karan Singh
| Updated: Oct 28, 2022 | Category: CDSCO

An Overview of Grant of Test License for Import under MDR, 2017

As per Section 40 of the MDR, 2017, any type of medical device or in-vitro diagnostic medical device may be imported to run any type of training testing, clinical investigation,...

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Form MD-3 and Form MD-5
Karan Singh
| Updated: Oct 20, 2022 | Category: CDSCO

What is the Purpose of Form MD-3 and Form MD-5?

In India, the manufacturing of medical devices requires strict processes to be completed under the Rules & Regulations of CDSCO (Central Drug Standard Control Organisation). Moreover, the applicant or manufacturers...

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CDSCO Registration for MRI Scan Machine
Karan Singh
| Updated: Oct 15, 2022 | Category: CDSCO

CDSCO Registration for MRI Scan Machine – An Overview

MRI or Magnetic Resonance Imaging; it's a type of scan that uses strong magnetic fields & radio waves to produce detailed images of the body inside the machine. It is...

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