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

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.

                  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.

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.

                     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.

                         CDSCO Fee for Product

The Professional Fee For CDSCO Medical Device Registration for BP Monitor is INR 99,999/- only with Monitrix.

Documents required in the CDSCO Registration 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

                                        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.

                         Why Monitrix

At Monitrix, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.