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CDSCO Manufacturing License for Craniotomy power tool system handpiece

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority responsible for pharmaceuticals and medical devices. Within the CDSCO are the Medical Device Division and the Diagnostics and Medical Devices Division, which both oversee the safety, effectiveness, and quality of medical devices. This is achieved mainly through pre-market and post-market supervision, ensuring that manufacturers comply with regulations and standards.

To manufacture medical devices like the Craniotomy Power Tool System Handpiece, a license from the CDSCO is mandatory. This demonstrates the company's commitment to quality, safety, and efficacy. It also establishes an essential dialogue with regulatory authorities, ensuring products meet the needs of the healthcare providers and patients. For more information about CDSCO and its initiatives, please visit their official portal.

What is a Craniotomy Power Tool System Handpiece?

The Craniotomy Power Tool System Handpiece is a handheld electrical device used by neurosurgeons to facilitate cranial surgeries. This specialised tool is designed to rotate cutting tools, such as drill bits, burs, trephines, or perforators, to create precise holes in the skull vault. These openings provide surgeons with access to the brain for intricate neurosurgical procedures. It can assist in procedures that may be challenging or more time-consuming with manual tools.

The Role of CDSCO in Medical Device Regulation

The CDSCO was established with the mission of safeguarding public health in India by ensuring the safety, efficacy, and quality of drugs and medical devices. Its regulatory framework for medical devices covers aspects such as clinical investigations, import, registration, manufacturing, sales, and distribution. The CDSCO is continually evolving its medical device regulations to be more aligned with international standards and practices, positioning India as an attractive market for global manufacturers.

How to manufacture a Craniotomy Power Tool System Handpiece

Manufacturing the Craniotomy Power Tool System Handpiece requires strict adherence to standards set by the CDSCO under risk class C. It is a complex process involving stringent quality control measures, technical specifications, and documentation requirements.

Fees for manufacturing license for Craniotomy Power Tool System Handpiece

To manufacture a Craniotomy Power Tool System, a manufacturer needs to apply for the MD9 license. The fees for the MD9 license stand at Rs. 50,000. Additionally, there is a per product fee of Rs. 1,000. For more details, check out this article.

Why is a Manufacturing License Necessary for Craniotomy Power Tool System Handpiece?

Obtaining a manufacturing license for the Craniotomy Power Tool System Handpiece is legally mandatory. A license guarantees that production aligns with quality and safety standards, protects patients from substandard products, and assures regulatory compliance. It further establishes trust and credibility with healthcare providers and patients.

Steps to Obtain a CDSCO Manufacturing License for Craniotomy Power Tool System Handpiece

  1. The first step involves submitting necessary documents, including the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Subsequent stages encompass review and approval from the CDSCO.
  3. If any discrepancies are identified, then necessary changes must be made.
  4. Lastly, once all required documents are submitted without errors, the license is approved and granted.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Craniotomy Power Tool System Handpiece as per Medical Device Rules, 2017?
The Craniotomy Power Tool System Handpiece is categorized under risk class C.

Q2. What license is needed to manufacture the Craniotomy Power Tool System Handpiece?
To manufacture a Craniotomy Power Tool System Handpiece, a MD9 license is required.

Q3. What are the fees for the MD9 license for the Craniotomy Power Tool System Handpiece?
The fee for the MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for the Craniotomy Power Tool System Handpiece?
The manufacturing license for the Craniotomy Power Tool System Handpiece will be issued by the CDSCO Headquarters in New Delhi.

Q5. Is repackaging of the Craniotomy Power Tool System Handpiece considered as manufacturing?
Yes, repackaging is considered as manufacturing as defined by the Drugs and Cosmetics Act. Thus, repackaging the Craniotomy Power Tool System Handpiece also requires an MD9 license.

Conclusion

Navigating the complex terrain of regulatory compliance can be a challenging task. Fortunately, you don't have to go it alone. The experts at Pharmadocx Consultants are here to assist you with obtaining the necessary licenses and meeting regulatory compliance for manufacturing your medical device.

To reach out for consultation or assistance, click here , call us at +91-7404557227 , or email [email protected]. Our dedicated team of experts is eager to provide you with the guidance you need to succeed in the medical device industry.

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