Updated on December 10, 2024 04:17:57 PM
CDSCO is the Central Drugs Standard Control Organisation, which is the Indian National Regulatory Body for Cosmetics,Pharmaceuticals and Medical Devices.It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.
In India, import,manufacturing,sale and distribution of drug and medical devices and cosmetics are regulated under Drugs and Cosmetics Act 1940 and rules 1945. CDSCO with state regulators are responsible for granting the license of specialized medical devices.
General Hospital Devices and Supplies are those medical devices that health professionals use to support patients or for their own health and safety that are covered in the same category.
There are more than 50 General Hospital Medical Devices, some of them are; Hydraulic Adjustable Hospital Bed, Therapeutic Medical Blinder, Neonatal Eye Pad, Jet lavage etc.
CDSCO registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of cardiovascular medical devices.
The selection of applications varies according to the device type,applicant characteristics,operations and home country approval. The CDSCO grants license for device testing,import or manufacturing after carefully evaluating each application.
Following steps should be considered for CDSCO registration for General Hospital Medical Devices;
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 General Hospital Medical Devices can be seen as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
Central Drugs Standard Control Organisation which is the National Regulatory Authority of India (NRA) issues licenses for specialized medical devices after checking the quality and efficiency of the device or product. Holding a CDSCO license enhances brand reputation and brings several benefits to the holder.
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.
CDSCO Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
SUGAM is the registration Portal of CDSCO
You can contact Professional Utilities for the complete procedure with documentation.
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