Updated on July 06, 2024 06:14:05 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,
An X-ray machine is any machine that involves X-rays. It may consist of an X-ray generator and an X-ray detector, a form of electromagnetic radiation to create images of the inside of an object. It diagnoses, monitors and treats many medical conditions painlessly, it visualizes internal structures of the body, it also supports medical and surgical treatment planning.
CDSCO Medical Device Registration for X-Ray Machine 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 can be followed for doing CDSCO Medical Device for X-Ray Machine:
To apply for CDSCO Registration you need to visit the official website of CDSCO. Open the ‘SUGAM CDSCO Portal’ then Click on the ‘SIGN UP HERE’ option.
The Registration form is divided into two parts, ‘Applicant Details’- the applicant needs to submit his/her personal details, ‘Registered Indian Address'- the applicant needs to submit his/her organization's details.
Complete the application process by submitting the required documents for the verification process.
To verify the registration, a confirmation link will be sent to the registered email Id. By clicking on the link, it will activate your account on the SUGAM portal.
After Clicking on the confirmation, the registration application will be sent to the concerned authority for approval. If the application got approved by the CDSCO Officials,an email of approval will be sent to the registered email Id, vice versa in the case of rejection.
The benefits acquired after CDSCO registration for X-Ray Machine can be seen as follows:
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
Following are the documents required in the CDSCO Registration for X-Ray Machine:
The intended use of the X-ray machine is to diagnose, monitor and treat any disability or Injury of the patient by capturing images of the internal body structure. As the main aim and objective of CDSCO is to safeguard public health. Therefore, CDSCO Medical Device Registration for X-Ray Machine is mandatory as per Medical Device Rules, 2017.
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; it is the governing authority which is responsible for granting the CDSCO license along with the state regulators.
The registration application is applied on the ‘SUGAM’ portal on the official website of CDSCO.
Covering letter,application form,quality certificate,instructions to use etc.
DCGI, Drug Controller General of India regulates Pharmaceuticals and Medical Devices and its positioning with the Ministry of Health and Family Welfare within CDSCO.
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