Updated on July 05, 2025 05:12:13 PM
CDSCO stands for The Central Drugs Standard and Control Organisation. It is India's National Regulatory Authority (NRA) for Cosmetics,Pharmaceuticals and Medical Devices, being a highly powerful organization of India.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceuticals & Medical Devices and its positioning with the Ministry of Health and Family Welfare.Under Drugs and Cosmetics Act 1940 and Rules 1945, Import,manufacturing,sale and distribution of drugs is regulated in India.
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CDSCO Registration for Oncology Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals,Medical Devices and Cosmetics.
CDSCO is constantly bringing out the transparency,accountability and uniformity in its service in order to ensure safety,efficacy and quality of Medical Devices manufactured,imported and distributed in the country.
The Procedure to acquire CDSCO Registration can be understood by following steps:
You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.
By clicking on the ‘Sign Up here’ option, the Registration purpose page will open. Select the ‘Registration Purpose page’ from the drop down box and click on ‘Submit’.
You need to fill-in all the necessary details on the ‘Applicant Register’ page, by providing personal and organizational details. Complete the procedure by submitting it.
Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.
To verify the registration, a confirmation link will be sent to your registered email Id. Click on the link to activate your account on the CDSCO SUGAM portal.
After clicking on the confirmation link, the registration application will be sent to the concerned authority ‘officials of CDSCO’ for approvalIf the application got approved by the officials, an email of approval will be sent to your registered email Id and vice versa for the case of rejection.
Importance of Ophthalmic Medical Device CDSCO Registration can be studied as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Documents required in the process are as follows
CDSCO for Oncology Medical Devices is a Mandatory step to be done as it qualifies the quality and efficiency of the medical devices. The application for Registration Certificate and Import License can be made to the Licensing Authority Under the act (to the Drugs Controller General) at CDSCO. As the Indian government announced its plan to bring all Medical Devices under a review of CDSCO, it is important to do CDSCO registration for Oncology 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.
Frequently Asked Questions
CDSCO stands for Central Drugs Standard Control Organisation; it is the governing authority which is responsible for granting the CDSCO license along with the state regulators.
The registration application is applied on the ‘SUGAM’ portal on the official website of CDSCO.
Covering letter,application form,quality certificate,instructions to use etc.
DCGI, Drug Controller General of India regulates Pharmaceuticals and Medical Devices and its positioning with the Ministry of Health and Family Welfare within CDSCO.
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