CDSCO Registration for Radiotherapy Medical Devices| Procedure, Documents

Updated on November 24, 2023 11:43:47 AM

Central Drugs Standard Control Organisation is the National Regulatory Authority of India. It comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Government of India.

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

Registration for Radiotherapy Medical Devices

What are Radiotherapy Medical Devices?

Radiotherapy uses radiation aimed at a specific area of the body to kill cancer cells. Radiotherapy can be given from a source outside the body (externally) or through a sealed device inserted inside the body (internally).

The Central Drug Standard Control Organisation made it mandatory for all Medical Devices to be regulated before they are sold or marketed in India as the Indian government has announced its plan to bring all the medical devices including implants and contraceptives under a review of CDSCO.

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What is CDSCO registration for Radiotherapy Medical Devices?

CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Government of India. Under the Drugs and Cosmetics Act, CDSCO is responsible for various activities of drugs, medical devices and cosmetics.

CDSCO registration for Radiotherapy Medical Devices 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.

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Procedure For CDSCO registration for Radiotherapy Medical Devices.

Following steps should be considered for CDSCO registration for Radiotherapy Medical Devices;

Step 1:SUGAM Portal

You need to visit ‘SUGAM’, the registration portal on the official website of CDSCO. Click on the ‘sign up here’ option to start the registration process.

Step 2:Filling up the Form

Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary details.

Step 3:Documentation

Complete the application process by submitting the required documents for the verification process which is done by the officials of CDSCO.

Step 4:Confirmation of registration

A confirmation link will be sent to the registered email Id to verify the registration. Click on the confirmation link to activate the account on CDSCO registration portal.

Step 5:Approval from the officials

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.

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Importance of Radiotherapy Medical Device CDSCO registration

Importance of CDSCO Registration can be seen as below;

  • Regulatory Compliance: CDSCO Registration provides Regulatory Compliance referring to a procedure of following relevant laws and regulations. CDSCO ensures that the Medical Devices that are used by the public are meeting the safety and quality standards set by CDSCO.
  • Safety & Quality of Products: CDSCO registration ensures that cosmetic products don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses under government regulations.
  • Unlock Market Access: CDSCO Registration is required before dealing with Drugs and Cosmetic Products. It makes sure that they are free of heavy metals and other toxins, ensuring they are safe to be consumed by the masses. It provides new opportunities in the Market.
Benefits for Radiotherapy Medical Devices
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CDSCO Fee for Product

The Professional Fee For CDSCO registration for Radiotherapy Medical Devices is INR 99,999/- only with Professional Utilities.

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Documents For CDSCO registration for Radiotherapy Medical Devices.

Documents for Radiotherapy Medical Devices

Important documents required in the process are as follows:

  • Form MD 40
  • Description of Medical Device
  • TR6 Challan
  • Power of Attorney
  • FSC (Free Sale Certificate)
  • Device Master File
  • Plant Master File
  • Full Quality Assurance Certificate
  • ISO Certificate-13485
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Conclusion

CDSCO stands for Central Drugs Standard Control Organisation which is responsible for the granting of licenses for Radiotherapy Medical Devices to check the quality and efficacy of the medical device. The application for registration certificate and import license is made to the licensing authority which is SLA for class A and B and CLA for class C and D.

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Frequently Asked Questions

How to register for CDSCO for Radiotherapy Medical Devices?

The registration application for Radiotherapy Medical devices can be applied on the SUGAM portal on the official website of CDSCO.

What is ‘SUGAM’ Portal?

It is an Online Portal Introduced by CDSCO. It offers various services including online submission,reviews and grant of NOC/Permission.

What are the categories of Medical Devices?

Notified and Non-Notified devices are the two types of Medical Devices with 4 classes involved in it A-B-C-D based on its risk level.

Why is CDSCO mandatory for Medical Devices?

The main aim and objective of CDSCO is to safeguard public health by ensuring the safety,efficacy and quality of medical devices.

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