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CDSCO Manufacturing License for Surgical Drill & its attachment

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for Indian pharmaceuticals and medical devices. As the 'Central Drug Authority', it plays a vital role in safeguarding and promoting public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. It is also responsible for approving new drugs and conducting clinical trials in the country. CDSCO is backed by a robust regulatory framework that firmly controls the medical device industry, granting manufacturing licenses to quality products that stand up to the rigorous protocols and guidelines of the organization.

Moreover, CDSCO is also responsible for granting manufacturing licenses, which are a vital part of the medical device industry. Manufacturing licenses ensure that the production of medical devices adheres to quality standards and regulations. This is where the Surgical Drill & its attachment step into the frame. The surgical drill and its attachment have a significant medical implication. They play a crucial role in Orthopaedic surgeries, assisting in critical procedures and ensuring patient health and recovery. To know more about CDSCO and its activities, visit their portal here.

What is a Surgical Drill & its attachment?

The Surgical Drill is a medical device, specifically designed to facilitate the process of drilling into the bone during Orthopaedic procedures. The drill, when rotated at an appropriate speed, will cut into the bone, creating a hole of the same dimension as the diameter of the bit. The drill's attachment can include various components such as drill bits, drill guides, burrs, and handpieces, each serving its own unique purpose in the surgical operation.

Surgical drills and their attachments are used in various procedures, including arthroscopic surgery, hip and knee replacement, and spinal surgery, among others. These devices have been transformative and vital in the realm of orthopaedic surgery, offering precision and efficiency to surgeons.

The Role of CDSCO in Medical Device Regulation

Since its inception years ago, Central Drugs Standard Control Organization (CDSCO) has come a long way in terms of regulating various aspects of the healthcare sector. In particular, its role in formulating and enforcing regulatory policies for medical devices cannot be stressed enough.

CDSCO provides a comprehensive regulatory framework for medical devices. The regulatory policies are designed to ensure quality standards and patient safety, striving for a culture of continuous improvement. The framework largely covers the product lifecycle from pre-market approval to post-market surveillance of medical devices.

How to manufacture a Surgical Drill & its attachment

The manufacturing of a surgical drill and its attachments falls under the ambit of Risk Class B as per CDSCO regulations. All manufacturers have to adhere to the guidelines stipulated by CDSCO and apply for the appropriate manufacturing license.

Fees for manufacturing license for Surgical Drill & its attachment

Given that the device falls under Risk Class B, the license fee required is for MD5. This involves a license fee of Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Surgical Drill & its attachment?

It's mandatory to have a manufacturing license for the Surgical Drill and its attachments. The license guarantees that the manufacturing process complies with the quality and safety protocols. Regulatory compliance is crucial in the healthcare sector as it protects consumers and patients from using substandard products and ensures that all medical devices in the market uphold high-quality standards.

Steps to Obtain a CDSCO Manufacturing License for a Surgical Drill & its attachment

  1. Collection of necessary documents which typically include Device Master File, Quality Management Certificate, Device Details, Site details, among others.
  2. Submitting the application to the right regulatory authority.
  3. Waiting for approval and handling any queries that emerge
  4. Addressing common challenges and taking corrective measures

Frequently Asked Questions (FAQs)

Q: What is the risk class of the Surgical Drill & its attachment as per Medical Device Rules, 2017?

The Surgical Drill & its attachment is classified as Risk Class B.

Q: What license is needed to manufacture the Surgical Drill & its attachment?

The required license is MD5

Q: What are the fees for the MD5 license for the Surgical Drill & its attachment?

The fees for an MD5 license for the Surgical Drill & its attachment are Rs. 5,000 for license and Rs. 500 per product

Q: Who will issue the manufacturing license for the Surgical Drill & its attachment?

For Class B devices such as the Surgical Drill & its attachment, the state FDA (Food and Drug Administration) will issue the license.

Q: Is repackaging the Surgical Drill & its attachment considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are also classified as drugs under the act, repackaging of the Surgical Drill & its attachment is also considered manufacturing and would require an MD5 license.

Conclusion

Navigating the regulation landscape can be a complex process, but it does not have to be. To gain expert assistance in the licensing process for your Surgical Drill & its attachment, contact Pharmadocx Consultants. You can reach us at +91-7404557227 or drop an email to [email protected]. Be it understanding more about the regulatory requirements or assuring the necessary documentation, our expert team is equipped to guide you through every step of the process. Check out more about the MD5 license in this article.

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