Updated on July 06, 2024 06:14:05 PM
Central Drugs Standard Control Organisation is the National Regulatory Authority of India. It comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Government of India.
CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its service in order to ensure safety, efficacy and quality of Medical Devices and Products manufactured, imported and distributed in the country.
Radiotherapy uses radiation aimed at a specific area of the body to kill cancer cells. Radiotherapy can be given from a source outside the body (externally) or through a sealed device inserted inside the body (internally).
The Central Drug Standard Control Organisation made it mandatory for all Medical Devices to be regulated before they are sold or marketed in India as the Indian government has announced its plan to bring all the medical devices including implants and contraceptives under a review of CDSCO.
CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Government of India. Under the Drugs and Cosmetics Act, CDSCO is responsible for various activities of drugs, medical devices and cosmetics.
CDSCO registration for Radiotherapy Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.
Following steps should be considered for CDSCO registration for Radiotherapy Medical Devices;
You need to visit ‘SUGAM’, the 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 confirmation link to activate the account on CDSCO registration 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 registration for Radiotherapy Medical Devices is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
CDSCO stands for Central Drugs Standard Control Organisation which is responsible for the granting of licenses for Radiotherapy Medical Devices to check the quality and efficacy of the medical device. The application for registration certificate and import license is made to the licensing authority which is SLA for class A and B and CLA for class C and D.
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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The registration application for Radiotherapy Medical devices can be applied on the SUGAM portal on the official website of CDSCO.
It is an Online Portal Introduced by CDSCO. It offers various services including online submission,reviews and grant of NOC/Permission.
Notified and Non-Notified devices are the two types of Medical Devices with 4 classes involved in it A-B-C-D based on its risk level.
The main aim and objective of CDSCO is to safeguard public health by ensuring the safety,efficacy and quality of medical devices.
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