Updated on July 06, 2024 06:14:00 PM
CDSCO refers to the Central Drugs Standard Control Organisation being India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
The Indian Government has announced its plan to bring all Medical Devices including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.
The Dialysis Machine mixes and monitors the Dialysate. Dialysate refers to the fluid which helps to remove unwanted products from the blood. It also helps electrolytes and minerals to reach their proper levels in the body.
A Dialysis Machine is a Medical Device that filters out extra waste and fluid from the body. It also regulates the blood pressure and the blood flow in the body.
CDSCO Medical Device Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
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 Medical Device registration for Dialysis Machine;
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.
Importance of CDSCO Medical Device Registration for Dialysis Machine can be studied as follows:
The Professional Fee For CDSCO Medical Device Registration for Dialysis Machine is INR 99,999/- only with Professional Utilities.
Note: The aforementioned Fees is exclusive of GST.
Following are the important documents required in the CDSCO Medical Device Registration;
CDSCO Registration for Dialysis Machine as a Medical Device 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 stands for Central Drugs Standard Control Organisations.
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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