Updated on September 04, 2024 01:20:57 PM
The Central Drugs Standard Control Organisation is one of the powerful organizations in India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health and Family Welfare.
A defibrillator is a Medical Device that sends an electric shock to the heart for restoring or correcting a normal heartbeat. It is used to treat life threatening conditions that affects the heart rhythm,such as ventricular fibrillation and ventricular tachycardia.
There are various kinds of Defibrillators as Automated external defibrillators (AEDs),Implanted cardioverter defibrillators (ICDs),Wearable cardioverter defibrillators (WCDs) which requires CDSCO registration.
CDSCO Medical Device registration for Defibrillators is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals,Medical Devices and Cosmetics.
CDSCO registration process is required to ensure the quality of the Medical Device as the main job and objective of CDSCO is to safeguard Public’s Health.
Following steps should be considered for CDSCO Medical Device registration for Defibrillators;
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 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 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.
If 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 Certificate is INR 99,999/- only with Professional Utilities.
Documents required in the process are listed below;
CDSCO registration is required for all kinds of Medical Devices as they contains a risk level.There has definitely been significant market growth in the medical device industry because of various factors, which is a necessary and profitable domain for the country. As the Indian government has announced its plan to bring all Medical Devices under a review of CDSCO thus it is important to complete the registration process on the official website of 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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Yes, CDSCO registration is required for any kind of Medical Device.
CDSCO stands for Central Drugs Standard Control Organisation.
The timeline for CDSCO Medical Device Registration for Defibrillators is 6-9 months after the application process is completed.
Registration on SUGAM portal, Filling up the Form,Documentation, Confirmation of registration, Approval from the officials.
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