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CDSCO Manufacturing License for Kidney stone filter

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's central regulatory body for pharmaceuticals and medical devices. Governed by the Ministry of Health & Family Welfare, CDSCO is responsible for approval of licenses for certain categories of drugs, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations and giving expert advice to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. This article will focus on the Kidney stone filter, a medical device used in Nephrology and Renal Care.

Manufacturing licenses play an important role in the medical device industry. They serve as an assurance that the manufacturing process follows recommended standards and norms, thus ensuring the safety and well-being of the patients using the devices. For the Kidney stone filter, a Class C device under the CDSCO risk classification, a specific license is required to ensure its standard of quality during the manufacturing process.

More information can be sought about licensing, regulations and applications for medical devices through the CDSCO's portal.

What is Kidney Stone Filter?

A Kidney stone filter is a medical device designed to be placed in the urinary duct. Its main function is to prevent a renal stone from moving from the kidney into the bladder. Its purpose is to provide relief to the patient by blocking the stone's path and preventing further complications.

The common use of a Kidney stone filter is during kidney stone surgeries or procedures involving the treatment of kidney stones, where it acts as a preventative measure against migrating stones that could create complications.

The Role of CDSCO in Medical Device Regulation

CDSCO plays an essential role in the regulation of medical devices in India. It defines the standards of quality that manufacturers need to adhere to during the production process, ensures patient safety and advocates for the uniform enforcement of the Drugs and Cosmetics Act.

One of the key responsibilities of CDSCO in medical device regulation is the classification of medical devices into risk classes - A, B, C & D. The classification carries a significant impact on the kind of manufacturing license required for the device. For example, a Kidney stone filter, considered a Class C device, would require an MD9 License.

How to manufacture Kidney Stone Filter

The manufacturing process of the Kidney stone filter consists of several stages, starting from designing and prototyping, to production, testing, and packaging. Each stage needs to adhere to the guidelines and standards laid by the CDSCO. However, the core prerequisite of this manufacturing process is the acquisition of the appropriate manufacturing license - MD9 in this case.

Fees for Manufacturing license for Kidney Stone Filter

For the Kidney Stone Filter - a Class C medical device, a MD9 license is required. The Fees for an MD9 license is Rs. 50,000 for the license, and Rs. 1,000 per product variant.

Why is a Manufacturing License Necessary for Kidney Stone Filter?

A manufacturing license for the Kidney Stone Filter is indispensable for a number of reasons:

  1. It is mandatory under the Drugs and Cosmetics Act to acquire the appropriate license for manufacturing medical devices.
  2. The license ensures that the manufacturing processes are adhering to the recommended safety standards and norms.
  3. Regulatory compliance plays a vital role in the healthcare sector, and a manufacturing license signifies the manufacturer's commitment to this compliance.
  4. A manufacturing license protects consumers and patients from substandard or faulty products, enhancing the trust in the medical device industry.

Steps to Obtain a CDSCO Manufacturing License for Kidney Stone Filter

  1. Collection and preparation of documents. Some of the documents needed include Device Master File, Quality Management Certificate, and details of the device and site.
  2. Submitting the application for the license.
  3. Comply with any recommendations or instructions provided during the approval process.
  4. Successfully receiving the license upon meeting all the requirements and passing the inspection.

More detailed guide on the process can be found right here.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Kidney Stone Filter as per Medical Device Rules, 2017?

Ans: The Kidney Stone Filter falls in Class C as per Medical Device Rules, 2017.

Q2: What license is needed to manufacture Kidney Stone Filter?

Ans: An MD9 license is required to manufacture Kidney Stone Filter.

Q3: What is the fees for the MD9 license for Kidney Stone Filter?

Ans: The fee for the MD9 license is Rs. 50,000, with an additional fee of Rs. 1,000 per product variant for the Kidney Stone Filter.

Q4: Who will issue the manufacturing license for Kidney Stone Filter?

Ans: For Class C medical devices such as the Kidney Stone Filter, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q5: Is repackaging of Kidney Stone Filter considered manufacturing?

Ans: Yes, as per the definitions under the provisions of the Drug Act, repackaging of Kidney Stone Filter is considered manufacturing and requires an MD9 license.

Conclusion

The process of obtaining a manufacturing license for a medical device such as the Kidney Stone Filter can be complex. It requires thorough understanding and adherence to regulatory frameworks and guidelines. If you need assistance or have further questions regarding these licenses, do not hesitate to reach out to Pharmadocx Consultants. You can reach us through a call on "+91-7404557227" or drop an email to "[email protected]". Our team of experienced consultants are here to guide you through the process and ensure you meet your compliance requirements.

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