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CDSCO Manufacturing License for Intramedullary Locking Nail Instrument Sets

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for drugs and medical devices. It plays a crucial role in maintaining the quality, safety, and effectiveness of healthcare products in the country. Functioning under the ambit of Ministry of Health & Family Welfare, CDSCO is responsible for the development and implementation of quality standards, regulations, and control strategies for drugs and medical devices, thereby ensuring the highest level of care and health protection for the Indian population.

In the medical device industry, obtaining a manufacturing license is critical. It not only ensures regulatory compliance but also guarantees the safety and efficacy of the products. One such vital device is the Intramedullary Locking Nail Instrument Sets, a valuable tool extensively used in orthopaedic surgeries. In this blogpost, we will explore all aspects of this instrument set, including its uses, manufacturing, license procedure, and much more. For more details related to CDSCO and medical device licenses, visit CDSCO's portal.

What is Intramedullary Locking Nail Instrument Set?

The Intramedullary Locking Nail Instrument Set is a collection of tools devised for orthopaedic procedures. It consists of instruments such as an Awl, Tissue Protector, Nut for coupling bolt, Proximal Jig, Distal Jig, Knob, Proximal Arm for Jig, Coupling bolt, Measuring device, T-handle, Universal Spanner, Tommy Bar, Ram, Ram Rod, Jig cover, Detachable Slide Hammer, F-Tool, Spanner Wrench, Standard Tamp, Screw Tightener, and Medullary tube Polyamide.

These instruments are used for 'Intramedullary nailing,' a common surgical procedure employed to treat fractures of long bones in the body. It involves inserting a metal rod into the medullary cavity of the bone, providing stability and aiding in faster recovery.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been committed to ensuring the availability of safe, effective, and high-quality medical devices to the Indian population. As the primary regulatory authority, it devises and implements regulatory frameworks, aiming at the standardization of medical devices produced and marketed within the country.

For medical devices, CDSCO has categorized them into four risk classes - Class A, B, C, and D, with Class A being the lowest risk, and Class D being the highest risk. The Intramedullary Locking Nail Instrument Set falls under Class B.

How to manufacture Intramedullary Locking Nail Instrument Sets

The manufacturing of Intramedullary Locking Nail Instrument Sets involves precise mechanical processes, high-quality material selection, rigorous quality checks, and adherence to CDSCO's rules and regulations.

Fees for manufacturing license for Intramedullary Locking Nail Instrument Sets

For manufacturing a Class B medical device like Intramedullary Locking Nail Instrument Sets, an MD5 license is required. The license fee is Rs. 5,000, and there's an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Intramedullary Locking Nail Instrument Sets?

Obtaining a manufacturing license is mandatory to manufacture any medical device in India. It ensures the production of high-quality products adhering to safety norms, thereby guaranteeing patient safety. Additionally, it signposts regulatory compliance, making it indispensable for manufacturers. A manufacturing license ultimately protects patients and consumers from possibly harmful sub-standard products.

Steps to Obtain a CDSCO Manufacturing License for Intramedullary Locking Nail Instrument Sets

  1. Ascertain the necessary pre-requisites and documentation required, which include Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application with all the required documents on CDSCO's portal.
  3. The application will undergo evaluation, followed by inspection of the manufacturing facility.
  4. On fulfillment of all regulatory norms, a license will be issued.

Obtaining a license can be challenging, knowing the process and having professional assistance can help smoothen the process. For more details on acquiring MD5 license, visit this link.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Intramedullary Locking Nail Instrument Sets as per Medical Device Rules, 2017?

  • The Intramedullary Locking Nail Instrument Sets fall under the Class B category.

Q2. What license is needed to manufacture Intramedullary Locking Nail Instrument Sets?

  • An MD5 license is required to manufacture Intramedullary Locking Nail Instrument Sets.

Q3. What is the fee for MD5 license for Intramedullary Locking Nail Instrument Sets?

  • The fee for the MD5 license is Rs. 5,000, and an additional Rs. 500 is charged per product.

Q4. Who will issue the manufacturing license for Intramedullary Locking Nail Instrument Sets?

  • For Class B devices like Intramedullary Locking Nail Instrument Sets, the state FDA will issue the license.

Q5. Is repackaging of Intramedullary Locking Nail Instrument Sets considered manufacturing?

  • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices, including Intramedullary Locking Nail Instrument Sets, are also drugs. Hence repackaging of this set requires an MD5 license.

Conclusion

With the growing medical device market, ensuring regulatory compliance is vital for manufacturers. Dive deeper into your licensing journey by reaching out to Pharmadocx Consultants. Their expert team can guide you, making this process simpler and faster. Connect today via phone "+91-7404557227" or email at "[email protected]". Get the right consultation and support for your medical device manufacturing dreams!

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