CDSCO (INDIA)
CDSCO Medical Device Registration for Organ Preservation Solution - Process, Importance, Documents required
Updated on February 13, 2025 03:11:32 PM
Organ preservation solutions are instrumental for the maintenance of the viability of organs from the time of retrieval until they can be implanted into another person. In India, organ preservation solutions are governed by the Medical Device Rules 2017 instituted by the Central Drugs Standard Control Organization (CDSCO). Organ preservation solutions have been categorized under the Class C category of medical devices and, since February 2020, CDSCO registration is strictly required for their sales and distribution in the country.
The registration process demands from the manufacturers and importers details about the composition, manufacturing process, and whether they are meeting the safety and quality standards. Proper registration is not only about legal compliance but also about ensuring that the products are credible and acceptable in the healthcare sector.
Professional Utilities has the expertise in guiding the client through the process of CDSCO certification. This includes documentation support, regulatory compliance, and the timely approval. Securing CDSCO certification will ensure the continued quality and safety of organ preservation solutions in India. Consulting regulatory experts may reduce the time taken to get the approval and ultimately ensure that all legal requirements are met.
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.
Process to do CDSCO Registration for Organ Preservation Solution.
Following steps should be considered for CDSCO registration for Organ Prevention Solution :
SUGAM Portal
Filling up the Form
Documentation
Confirmation of registration
Approval from the officialsStep 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.
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.
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 Registration for Organ Preservation Solution is INR 99,999/- only with Cokion.
Documents required in the CDSCO Registration for Organ Preservation Solution
When registering an Organ Preservation Solution with the Central Drugs Standard Control Organization (CDSCO), the following essential documents must be submitted:
- Form under Drugs and Cosmetics Rules: A completed form in accordance with the regulations.
- ISO 13485 Certificate: Certification confirming compliance with quality management systems for medical devices.
- Manufacturer Details: Information about the manufacturer, including registration and facility details.
- Full Quality Assurance Certificate: Proof of comprehensive quality assurance measures.
- Nature of Activity: Information about whether the product is for import or export.
- Undertaking of Authenticity: A statement confirming the accuracy of all submitted information.
- Brand Name: If applicable, the brand name registered under the Trade Marks Act, 1999.
- FSC / Foreign Government Certificate: A certificate from the foreign government, if applicable.
- Device Master File: Detailed documentation on the design and manufacturing of the product.
- Plant Master File: Information about the manufacturing facility, including its operations and compliance with standards.
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
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.
DCGI, Drug Controller General of India regulates Pharmaceuticals and Medical Devices and its positioning with the Ministry of Health and Family Welfare within CDSCO.
There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.