CDSCO Medical Device Registration for Organ Preservation Solution - Process, Importance, Documents required

Updated on January 30, 2024 04:06:16 PM

CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning with the Ministry of Health and Family Welfare.

Registration for Organ Preservation Solution

What is an Organ Preservation Solution?

Organ Preservation is a process of keeping organs viable for transplantation after they are removed from the donor body to transplant them into the receiver's body.

The main methods of Organ Preservation are Static Cold Storage and Machine Perfusion. The process includes removing, storing and transporting. The goal of Organ Preservation Solution is to maintain the organ’s function and viability, allowing for successful transplantation.

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What is CDSCO Registration for Organ Preservation Solution?

CDSCO registration is a process of acquiring approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Cosmetics and Medical Devices.

The Registration for Organ Prevention Solution under CDSCO is an important step to be done to avoid any hindrances related to the activities involved in the domain. As in India, Import, Manufacturing, Sale and Distribution of Drugs, Cosmetics and Pharmaceuticals is regulated under Drugs and Cosmetics Act 1940.

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Process to do CDSCO Registration for Organ Preservation Solution.

Following steps should be considered for CDSCO registration for Organ Prevention Solution;

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:Inspection Process

For the devices that falls under class B, the notified body will inspect them within three months of submitting the application form. If the device is under classes C & D, an inspection will be conducted by authorized officials.

Step 6: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 CDSCO Registration

Importance of CDSCO registration for Organ Prevention Solution can be seen as follows:

  • Brand Recognition: CDSCO registration enhances the manufacturer’s brand recognition and credibility, as it demonstrates that the Organs have met rigorous safety, efficacy, and quality standards.
  • Safeguard the public health: The vision and mission of Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance the public health by assuring the safety, efficacy, and quality of Medical Devices to be consumed by the masses.
  • 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.
Benefits for Organ Prevention Solution
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CDSCO Fee for Product

The Professional Fee For CDSCO Registration for Organ Preservation Solution is INR 99,999/- only with Professional Utilities.

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Documents required in the CDSCO Registration for Organ Preservation Solution

Documents for Organ Preservation Solution

Important documents required in the process are as follows:

  • Form under the Drugs and Cosmetic Rules
  • ISO 13485 Certificate
  • Details of the Manufacturer
  • Full Quality Assurance Certificate
  • Nature of activity (import/export)
  • Undertaking that all the information provided is authentic
  • Brand Name (if registered under the Trade Marks Act, 1999)
  • FSC / Certificate by the Foreign Government
  • Device Master File
  • Plant Master File
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Conclusion

Organ Preservation is a process of keeping organs viable for transplantation after they are removed from the donor body to transplant them into the receiver's body. CDSCO is constantly thriving upon to bring out transparency,accountability and uniformity in its service in order to ensure safety, efficacy and quality of products in the country.

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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 Organ Prevention Solution?

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

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.

How many types of classes are present for Medical Devices?

There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.

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