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CDSCO Manufacturing License for Kidney donor-organ preservation/transport system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) serves as the apex body for regulation and supervision of standards related to pharmaceuticals and medical devices in India. Its functions are much more than simply drafting and enforcing laws and regulations. Key functions of the CDSCO also include the approval of new drugs and medical devices, enforcing quality control, and ensuring safety and efficacy of healthcare products. The role of CDSCO in India’s healthcare industry is vital because this organization ensures that medical products are up to the required quality standards, safe, and effective.

In the medical device industry, manufacturing licenses play a vital role since they act as an assurance of the quality and safety of the devices. It not only certifies that the device has been manufactured following the regulations but also boosts the consumer's trust in the product. Our focus in this blog is the 'Kidney donor-organ preservation/transport system'. This device plays a crucial role in nephrology and renal care and its manufacturing process follows stringent regulations for ensuring its safety and efficacy.

Visit here to reach the CDSCO's portal.

What is a Kidney donor-organ preservation/transport system?

A kidney donor-organ preservation/transport system is a specialized device that supports and maintains a donated kidney organ during its transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. They are designed to maintain the organ's viability during transport by providing suitable temperature conditions and circulation of preservation solutions.

Common uses of this device include kidney transplantation procedures. The device plays an essential role in effective organ transplantation by ensuring the donated kidney remains viable for surgery.

The Role of CDSCO in Medical Device Regulation

Established with a vision to ensure the availability of safe, effective, and quality medical devices for the citizens, CDSCO has always striven to uphold its mission. The regulatory framework from CDSCO for medical devices ensures the implementation of the stringent quality of manufacturing processes.

How to manufacture a Kidney donor-organ preservation/transport system

Manufacturing a kidney donor-organ preservation/transport system requires expert knowledge and a complete understanding of the device's mechanism. It is crucial to comply with the quality standards and safety protocols prescribed by regulatory bodies like CDSCO.

Fees for manufacturing license for a Kidney donor-organ preservation/transport system

The Kidney donor-organ preservation/transport system falls under class C risk class and thus requires an MD9 license for manufacturing. The fees for license MD9 is Rs. 50,000 and the additional fee per product is Rs. 1,000.

Why is a Manufacturing License Necessary for a Kidney donor-organ preservation/transport system?

Acquiring a manufacturing license is mandatory and for good reason. This license serves as proof that the manufacturing processes follow the standards set by regulatory bodies, ensuring the production of quality and safe medical devices. It holds great importance in the healthcare sector, where products directly impact human health. Moreover, it protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Kidney donor-organ preservation/transport system

  1. Collating the required documents, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submitting the application for the license
  3. Waiting for the application review and dialogue with the regulatory officials
  4. Working on the feedback and finally obtaining the approval

The process might look straightforward, but it involves overcoming several challenges that require expert consultation.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of a Kidney donor-organ preservation/transport system as per Medical Device Rules, 2017?

As per the Medical Device Rules, 2017, a Kidney donor-organ preservation/transport system falls under class C.

Q2: What license is needed to manufacture a Kidney donor-organ preservation/transport system?

For manufacturing a Kidney donor-organ preservation/transport system, an MD9 license is required.

Q3: What is the fees for an MD9 license for a Kidney donor-organ preservation/transport system?

The fees for an MD9 license is Rs. 50,000 plus Rs. 1,000 per product.

Q4: Who will issue a manufacturing license for a Kidney donor-organ preservation/transport system?

For class C devices, the CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of a Kidney donor-organ preservation/transport system considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of a Kidney donor-organ preservation/transport system is also considered manufacturing, requiring an MD9 license.

Conclusion

Navigating through the process of obtaining a CDSCO manufacturing license might seem daunting. However, with the right guidance and consultation, the process can be simplified. Pharmadocx Consultants provide expert assistance for obtaining the CDSCO manufacturing license.

Do not hesitate to reach out to them via their website at https://www.pharmadocx.com, call at "+91-7404557227" or send an email to "[email protected]".

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