Updated on July 06, 2024 06:14:04 PM
CDSCO is the Central Drugs Standard Control Organisation, It is the National Regulatory Authority of India. CDSCO along with state regulators is responsible for granting the license of Medical Devices.
CDSCO comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India. The Indian government has announced its plans to bring all medical devices,including implants and contraceptives under a review of CDSCO.
Paediatrics is a speciality of medicine that is concerned with the health and medical treatment of babies, children, and adolescents from their birth until they reach the age of eighteen years.
Neonatology is a specialization of paediatrics that focuses on the medical treatment of newborn babies, particularly sick or born prematurely. It is primarily a hospital-based specialty most often seen in neonatal intensive care units (NICUs).
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 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.
We can consider following steps of CDSCO Medical Device registration for Paediatrics and Neonatology;
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 CDSCO Medical Device Registration for Paediatrics and Neonatology can be studied as follows:
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
Documents required in CDSCO Registration are as follows:
CDSCO Medical Device registration for Paediatrics and Neonatology is a mandatory step to be done as the Indian government has announced its plan to bring all medical devices including implants and contraceptives under a review of CDSCO. The application for registration certificate or import license can be made to the Licensing authority at CDSCO.
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 refers to the Central Drugs Standard Control Organisation.
It 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.
You can start the application process by signing up on the ‘SUGAM’ portal on the official website of CDSCO.
Details and address proof of the applicant,description of the medical device,legal form,PMS report,plant master file,device master file,other regulatory certificates.
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