Updated on July 06, 2024 06:14:01 PM
CDSCO refers to the Central Drugs Standard Control Organisation being India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
The Indian Government has announced its plan to bring all Medical Devices including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.
A Glucometer can also be referred to as a Glucose meter. It is a medical device that is used to check blood glucose at home in a convenient way. This device is designed and programmed to test blood sugar level with a single drop of blood. A Glucometer is also referred to as Self-monitoring of blood glucose.
CDSCO Medical Device Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
The selection of applications varies according to the device type, applicant characteristics, operations and home country approval. The CDSCO grants license for device testing, import or manufacturing after carefully evaluating each application.
Following steps should be considered for CDSCO Medical Device registration for Glucometer;
You need to visit the ‘SUGAM’ registration portal on the official website of CDSCO. Click on the ‘sign up here’ option to start the registration process.
Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary details.
Complete the application process by submitting the required documents for the verification process which is done by the officials of CDSCO.
A confirmation link will be sent to the registered email Id to verify the registration. Click on the link to activate the account on CDSCO-portal.
Once the confirmation link is clicked, the application for registration will be sent to the concerned authority for an approval after the verification of the formal documents.
The Importance of CDSCO Medical Device registration for Glucometer for can be seen as follows:
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
Under the Drugs and Cosmetics Act and Rules, 1940 and 1945, CDSCO being the National Regulatory Body of India is the concerned authority for approving the license for Drugs, Cosmetics and Medical Devices.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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As the Indian Government has announced its plan to bring medical devices including implants and Contraceptives under a review of CDSCO.
The Drugs and Cosmetics Rules,1945,classify drugs under given schedules and present guidelines for the storage,sale,display and prescription of each schedule.
CDSCO, Central Drug Standard Control Organisation is India’s National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals and Medical Devices.
There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.
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