CDSCO registration is needed to prevent spurious inferior quality medical devices from entering the Indian health care market. In this blog, we will focus on organ preservation solution that has been designated as a medical device by the CDSCO. We will delve into the process and requirements for the CDSCO registration for organ preservation solution.

CDSCO registration for organ preservation solution in India

Given the impact and demand for organ preservation solution in Indian market, regulatory guidelines are needed to ensure patient safety. Moreover, inferior quality products can have negative consequences. CDSCO registration for organ preservation solution ensures substandard and inferior quality products do not reach the Indian healthcare system. Thus, organ preservation solutions are stringently regulated by CDSCO guidelines. CDSCO regulations for organ preservation solutions monitor and control their safety, quality, and efficacy. This in turn ensures that the quality and standard of the Indian medical device and healthcare sectors are maintained. Therefore, as per CDSCO guidelines, organ preservation solution marketed in India needs to be mandatorily registered with the CDSCO.

CDSCO class for organ preservation solutions

For the ease of CDSCO registration, the regulatory body has categorised medical devices into four classes. In the ascending order of risk level, Class A, B, C, and D are the four CDSCO classes. The CDSCO license application process and form required will depend on the CDSCO class to which the medical device belongs to. The CDSCO has provided a definition for organ preservation solution and designated it to a particular class. This will help with the CDSCO registration for organ preservation solution.

As defined by CDSCO, the organ preservation solution is a solution used for hypothermic flushing, storage, and transport of organs. It is used to maintain the organ vitality during transplant into human recipients. Depending on the risk level and intended use, CDSCO has classified the organ preservation solution as Class C.

CDSCO registration for organ preservation solution: Application form and license

Specific application form is required and license is issued for organ preservation solutions. We have summarized it for you.

• Manufacturing license: Entities seeking to obtain a license for manufacturing organ preservation solutions in India need to apply using the Form MD-7. The company has to apply online and pay the necessary processing fee. Next, medical device regulatory officers will inspect the production facility within 60 days from the date of application. Then, the regulatory body will relay the approval via Form MD-9. This will permit the manufacturing company to manufacture, sell, and distribute organ preservation solutions in India.
• Import license: The application for securing the CDSCO license to import organ preservation solutions is filed under MD 14. Then, the regulatory officials will review the application and verify the documents. After which, they will issue the license to import the solutions under MD 15.
• Loan license: A loan license can be used to manufacture medical devices when the manufacturer does not own a manufacturing facility. Manufacturers seeking to obtain a loan license for manufacturing organ preservation solutions in India need to apply using Form MD-8.  The medical device manufacturer has to apply online and pay the necessary processing fee. Next, the medical device regulatory officers will inspect the production facility within 60 days from the date of application. Then, the regulatory body will relay the approval via Form MD-10. This will permit the manufacturer to manufacture, sell, and distribute organ preservation solutions in India with a loan license.

Importance of CDSCO registration for organ preservation solution

CDSCO regulates and controls medical devices marketed in India. A CDSCO license is required to market and distribute medical devices in India. Compliance with several regulations associated with device classification, quality, and patient safety standards is required to obtain the license. We have highlighted the importance of CDSCO registration for organ preservation solution.

• CDSCO registration demonstrates the compliance of the manufacturer with Indian regulatory requirements, including Good Manufacturing Practice and Medical Devices Rules.
• A CDSCO registration indicates the organ preservation solution has met rigorous safety, efficacy, and quality standards laid down by the regulatory body. Additionally, this increases the manufacturer’s brand recognition and credibility.
• A mandatory CDSCO registration for organ preservation solution will safeguard public health. It ensures medical devices only of certain quality and standard reach the Indian public.
• There is increased customer trust in products with valid CDSCO manufacturing license.
• For manufacturing or importing organ preservation solution for sale in India, securing a CDSCO license is mandatory. Thus, CDSCO registration provides access to one of the largest medical device markets in the world. India is a potential hub for medical devices. Thus, entering the Indian medical device market is a lucrative option for many medical device companies.

Documents required for CDSCO registration

CDSCO regulations for organ preservation solutions have specified the required documents for the application process. Separate sets of supporting documents are required depending on the application form. CDSCO has provided a detailed checklist of documents that should accompany each application form. The checklist can be found here. We have provided an overview of the documents required.

• Cover letter
• Details and address proof of the applicant
• Power of attorney
• TR6 challan
• Quality assurance certificate
• ISO 13485 certificate
• CE design certificate
• Free sale certificate
• Plant master file
• Device master file

The above list provides a basic outline of the documents required. We are ready to help you with a detailed list of documents required. Our team will also assist you in crafting these documents and help you with all your documentation needs. Additionally, we will compile the documents, as per regulatory guidelines. Feel free to contact us, for all your documentation needs.

CDSCO organ preservation solution registration process

The first step is usually to check whether CDSCO registration for medical devices is required for your product. Per CDSCO guidelines, organ preservation solution is considered notified devices and need to be registered. The registration process will be per the guidelines for Class C medical devices. In case of a foreign medical device manufacturing company, an Indian authorized agent will be required. This agent will act on behalf of the foreign company.

An overview of the registration process:

1. Login/Signup: SUGAM is the official CDSCO online registration portal. You need to login/signup on the official portal.
2. Form filling: The applicable form needs to be filled in correctly, per the guidelines for Class C medical devices.
3. Documentation: The required supporting documents need to be collated. Additionally, the documents need to be arranged per CDSCO guidelines.
4. Application: The application has to be sent online via the CDSCO online registration portal.
5. Approval: The regulatory body officials will review the application and verify the documents submitted. After which, if the necessary criteria are fulfilled, then the regulatory body will grant the license.

Licensing authority for CDSCO registration for organ preservation solution

Manufacturers seeking to obtain a CDSCO license for organ preservation solution need to apply to the Central Licensing Authority (CLA). The CLA grants licenses for all Class C and D medical devices manufactured, distributed, and sold in India.

Time required to obtain the CDSCO registration for organ preservation solution

The approximate time required for obtaining the CDSCO registration for organ preservation solution is 6 to 9 months. However, the time required may vary.

Pharmadocx Consultants can make organ preservation solution registration in India hassle-free

CDSCO registration for organ preservation solution can be tricky from choosing the correct form, filling the form correctly to preparing the necessary documents. Furthermore, understanding the CDSCO regulations for organ preservation solution is difficult. Pharmadocx Consultants can make the CDSCO registration process a breeze so that you can focus on establishing your business. Additionally, as authorized agents we can help foreign companies register their medical device business in India. Drop an email at [email protected] or call/Whatsapp on 9996859227 to get support from our team of industry experts.