CDSCO (INDIA)
CDSCO Medical Device Registration for X-Ray Machine - Procedure, Documents, Benefits
Updated on December 07, 2024 03:25:52 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.
- What is an X-Ray Machine as a Medical Device?
- What is CDSCO Medical Device Registration for X-Ray Machine?
- Procedure for CDSCO Medical Device Registration for X-Ray Machine
- Benefits acquired after CDSCO Registration for X-Ray Machine
- CDSCO Fee for Product
- Documents required in CDSCO Registration for X-Ray Machine
- Conclusion
- Frequently Asked Questions
What is an X-Ray Machine as a Medical Device?
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.
What is CDSCO Medical Device Registration for X-Ray Machine?
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.
Procedure For CDSCO Medical Device Registration for X-Ray Machine.
Following steps can be followed for doing CDSCO Medical Device for X-Ray Machine :
Online Registration
Filling up the details
Document Submission
Verification of the Registration
Approval from AuthorityStep 1 : Online Registration
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.
Step 2 : Filling up the details
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.
Step 3 : Document Submission
Complete the application process by submitting the required documents for the verification process.
Step 4 : Verification of the Registration
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.
Step 5 : Approval from Authority
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.
Benefits required after CDSCO Registration for X-Ray Machine
The benefits acquired after CDSCO registration for X-Ray Machine can be seen as follows :
- Indian Market Access: India has the largest Pharmaceuticals and medical device market in the world. CDSCO registration allows the manufacturers and importers to sell their products to the consumers in the Indian Market with no hindrances.
- Ensuring Safety: The main aim of the Central Drugs Standard Control Organisation is to safeguard public health. The quality and efficiency of the device or product goes under a verification process done by the CDSCO officials. The safety and health issues of certain types of equipment are not a concern with registered Medical Devices as a finished product.
- Brand Recognition: CDSCO registration enhances the manufacturer's brand recognition and credibility, as it demonstrates that the products have met rigorous safety, efficacy, and quality standards.
CDSCO Fee for Product
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Cokion.
Documents For CDSCO Registration for X-Ray Machine
Following are the documents required in the CDSCO Registration for X-Ray Machine :
- Application Form (Form 40)
- ISO 13485 Certificate
- TR6 Challan
- Undertaking that only authentic details are provided
- Power of Attorney
- Full quality assurance certificate
- CE Design certificate
- Declaration of conformity
- Device master file
- FSC (Free Sale Certificate)
- Plant master report
Conclusion
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.
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Frequently Asked Questions
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.