Updated on December 07, 2024 03:38:48 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.
A Nebulizer is a piece of Medical equipment, used by a person with asthma or another respiratory condition which is used to start medication directly and quickly.
It is a medical device also known as atomizers that converts liquid medicine into mist or aerosol, which has to be inhaled directly to the lungs. A nebulizer is used to treat respiratory conditions.
CDSCO Registration is the process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
Importers and Manufacturers of Nebulizers need to take an Import and Manufacturing license from the concerned authority in order to perform several activities with no hindrances.
Following steps should be considered for CDSCO Medical Device Registration for Nebulizer;
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.
The benefits acquired after CDSCO registration for Nebulizer can be seen as follows:
The Professional Fee For CDSCO Medical Device Registration for Nebulizer is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
CDSCO Medical Device Registration for Nebulizer is a mandatory step to be done under Medical Device Rules,2017. The selection of applications varies according to the device type, applicant characteristics, and home country approval. The CDSCO grants licenses for device testing, Import or Manufacturing after carefully evaluating each application.
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 Organisations.
Central Drugs Standard Control Organisation is India’s national regulatory body for Cosmetics,Pharmaceuticals and Medical Devices.
Under the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices & its positioning with the Ministry of Health and Family Welfare.
The registration form should be completed by the Authorized Signatory/Responsible Person of the organization.
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