Updated on December 09, 2024 04:26:45 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 Blood Pressure monitor is a digital medical device that is used to check the blood pressure of human beings and to track their readings. It is also known as Digital BP Monitor, It is a diagnostic tool to check the blood pressure levels 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 BP Monitor;
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.
The Benefits of CDSCO Medical Device registration for BP Monitor for can be seen as follows:
The Professional Fee For CDSCO Medical Device Registration for BP Monitor is INR 99,999/- only with Professional Utilities.
Note: The aforementioned Fees is exclusive of GST.
Important documents required in the process are as follows:
Under the Drugs and Cosmetics Act and Rules, 1940 and 1945, CDSCO being the National Regulatory Body of India is the concerned authority for approving the license for Drugs, Cosmetics and Medical Devices. The process for the CDSCO Medical Device Registration for BP Monitor is quite lengthy and complex but you can rely on Professional Utilities for complete procedure and guidance.
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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As the Indian Government has announced its plan to bring medical devices including implants and Contraceptives under a review of CDSCO.
The Drugs and Cosmetics Rules, 1945, classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule.
The fee for doing CDSCO Registration for BP Monitor is ₹99,999 + additional fee of the medical device at Professional Utilities.
There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.
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