CDSCO Registration for Oncology Medical Devices - Process, Documents

Updated on January 03, 2024 04:25:43 PM

CDSCO is a highly powerful Organisation in India referring to the Central Drugs Standard Control Organisation. It is the 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 CDSCO, thus it is mandatory to register under CDSCO for Oncology Medical Devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical & Medical Devices and its positioning with the Ministry of Health and Family Welfare.

Registration for Oncology Medical Devices

What are Oncology Medical Devices?

Oncology Medical devices are used in diagnosing, treating and mapping the severity of cancer and tumors such as MRI’s, Pet Scans, Ultrasound etc.

There are various types of Oncology Medical devices that needs to be registered with CDSCO in order to comply with the latest Medical Devices Rules in India, these are the legal framework for regulating the import, manufacture, distribution and sale of the medical devices, drugs and cosmetics in India under the Drugs and Cosmetics Act 1940 and Rules 1945.

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What is CDSCO Registration for Oncology Medical Devices?

CDSCO Registration for Oncology Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.

CDSCO is constantly bringing out the transparency, accountability and uniformity in its service in order to ensure safety, efficacy and quality of Medical Devices manufactured, imported and distributed in the country.

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Procedure for CDSCO Registration for Oncology Medical Device.

The Procedure to acquire CDSCO Registration can be understood by following steps:

Step 1:Signing Up

You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.

Step 2:Registration Page

By clicking on the ‘Sign Up here’ option, the Registration purpose page will open. Select the ‘Registration Purpose page’ from the drop down box and click on ‘Submit’.

Step 3:Filling the details

You need to fill-in all the necessary details on the page, by providing personal and organizational details. Complete the procedure by submitting it.

Step 4:Documentation

Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.

Step 5:Verification Process

To verify the registration, a confirmation link will be sent to your registered email Id. Click on the link to activate your account on the CDSCO SUGAM portal.

Step 6:Approval from the authority

After clicking on the confirmation link, the registration application will be sent to the concerned authority ‘officials of CDSCO’ for approvalIf 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.

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Importance of CDSCO Registration for Oncology Medical Device

Importance of Oncology Medical Device CDSCO Registration can be studied as follows:

  • Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
  • Regulatory Compliance: CDSCO Registration provides Regulatory Compliance referring to a procedure of following relevant laws and regulations, CDSCO ensures that the Medical Products that are used by the public shouldn't be hazardous to them.
  • Improving a Company's Reputation: Holding a CDSCO license serves as a proof of completing the government policy and working under all the terms and conditions, which improves the reputation of the Company in the domain.
Benefits for Oncology Medical Device
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CDSCO Fee for Product

The Professional Fee For CDSCO import Certficate for Cosmetic products is INR 99,999/- only with Professional Utilities.

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Documents required in the CDSCO for Oncology Medical Device process.

Documents for Oncology Medical Device

Documents required in the process are as follows

  • Form MD 40
  • Covering Letter
  • Details of the Medical Device
  • Copy of Authorization Letter issued by Director/Company Secretary
  • Quality Assurance Certificates
  • Instructions for Use
  • Undertaking from Testing Laboratory
  • Identity and Address Proof of the Applicant
  • ISO Certificate-13485
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Conclusion

CDSCO for Oncology Medical Devices is a Mandatory step to be done as it qualifies the quality and efficiency of the medical devices. The application for Registration Certificate and Import License can be made to the Licensing Authority Under the act (to the Drugs Controller General) at CDSCO. As the Indian government announced its plan to bring all Medical Devices under a review of CDSCO, it is important to do CDSCO registration for Oncology Medical Devices.

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Frequently Asked Questions

What is CDSCO and why is it Important?

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.

Where to apply for CDSCO registration for Oncology Medical Devices?

The registration application is applied on the ‘SUGAM’ portal on the official website of CDSCO.

What documents are required for CDSCO registration for Oncology Medical Devices?

Covering letter,application form,quality certificate,instructions to use etc.

Who regulates Pharmaceuticals and Medical Devices within CDSCO?

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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