Updated on July 06, 2024 06:14:04 PM
CDSCO is a highly powerful Organisation in India referring to the Central Drugs Standard Control Organisation. It is the 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 CDSCO, thus it is mandatory to register under CDSCO for Oncology Medical Devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical & Medical Devices and its positioning with the Ministry of Health and Family Welfare.
Oncology Medical devices are used in diagnosing, treating and mapping the severity of cancer and tumors such as MRI’s, Pet Scans, Ultrasound etc.
There are various types of Oncology Medical devices that needs to be registered with CDSCO in order to comply with the latest Medical Devices Rules in India, these are the legal framework for regulating the import, manufacture, distribution and sale of the medical devices, drugs and cosmetics in India under the Drugs and Cosmetics Act 1940 and Rules 1945.
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
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 Oncology Medical Device CDSCO Registration can be studied as follows:
The Professional Fee For CDSCO import Certficate 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.
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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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