Updated on July 06, 2024 06:14:00 PM
CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning with the Ministry of Health and Family Welfare.
Dermatology and Plastic Surgery, these are two medical specialties that deals with body and skin appearance. Cautery, Diathermy, Dermatoscope etc are some of the Medical Devices needed.
CDSCO Registration is required for these Medical Devices in order to follow all the norms released by the government regarding Drugs, Cosmetics and Medical Devices under the Drugs and Cosmetics Act 1940.
CDSCO registration is a process of acquiring approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Cosmetics and Medical Devices.
The Registration for Dermatology and Plastic Surgery under CDSCO is an important step to be done to avoid any hindrances related to the activities involved in the domain. As in India, Import, Manufacturing, Sale and Distribution of Drugs, Cosmetics and Pharmaceuticals is regulated under Drugs and Cosmetics Act 1940.
Following steps should be considered for CDSCO registration for Cardiovascular Medical Devices;
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 personal and organizational details.
Complete the application process by submitting the required documents for the verification process which is done by CDSCO officials.
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.
Importance of CDSCO Registration can be seen as below;
The Professional Fee For CDSCO import Certificate for Cosmetic products 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. The process for the CDSCO Registration is quite lengthy and complex but you can rely on Professional Utilities at the amount of ₹99,999/- as a professional fee for complete procedure and guidance.
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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