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CDSCO Manufacturing License for Stereotactic neuronavigation/ planning system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in ensuring the quality, safety, and efficacy of medical devices n the Indian market. The CDSCO, under the aegis of the Ministry of Health and Family Welfare, is responsible for ensuring public safety by ensuring that medical devices meet established standards.

Manufacturing licenses are vital in the medical device industry to ensure that devices are produced according to stringent guidelines, thus ensuring quality and safety for end-users. One such device is the Stereotactic neuronavigation/ planning system which has significant medical implications, especially in neurology. For further information, please refer to CDSCO's portal.

What is Stereotactic neuronavigation/planning system?

Stereotactic neuronavigation/planning systems are technologically advanced devices in the field of neurology. It involves a non-invasive technique that enables neurosurgeons to locate and treat small targets within the brain with high precision. It analyses patient's MRI images and uses a 3D optical positioning system for the treatment probes and instruments.

These systems are used in procedures such as biopsy, ablation, deep brain stimulation, and other types of neurosurgery.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been regulating medical devices since its establishment. It is responsible for approving new medical devices, clinical trials, laying down standards, control over the quality of imported devices and coordination of state licensing authorities besides, many others.

For medical devices, the CDSCO has categorized them into four classes A, B, C and D based on the risk involved.

How to manufacture Stereotactic neuronavigation/ planning system

The manufacturing of Stereotactic neuronavigation / planning system (a Class B device) requires an MD5 license according to CDSCO regulations.

Fees for manufacturing license for Stereotactic neuronavigation/planning system

The license required, MD5, cost Rs. 5,000 and the fees per product is Rs. 500.

Why is a Manufacturing License Necessary for Stereotactic neuronavigation/planning system?

The manufacturing license is a mandatory requirement set by the CDSCO. It ensures quality and safety in production and helps in regulatory compliance in the healthcare sector, protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Stereotactic neuronavigation/planning system

The process includes prerequisites like the Device Master File, Quality Management Certificate, and device and site details etc. The license procedure consists of four stages - application submission, technical scrutiny and clarification, license issuance or rejection, and application reconsideration.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Stereotactic neuronavigation/planning system as per Medical Device Rules, 2017?
A1. The Stereotactic neuronavigation/planning system falls under Class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Stereotactic neuronavigation/planning system? A2. The MD5 license is needed to manufacture Stereotactic neuronavigation/planning system.

Q3. What is the fees for MD5 license for Stereotactic neuronavigation/planning system? A3. The fees for the MD5 license for Stereotactic neuronavigation/planning system is Rs. 5,000 for license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Stereotactic neuronavigation/planning system? A4. For class B devices like Stereotactic neuronavigation/planning system, the state FDA will issue the license.

Q5. Is repackaging of Stereotactic neuronavigation/planning system considered manufacturing? A5. 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 the Stereotactic neuronavigation/ planning system is also considered manufacturing requiring an MD5 license.

For a more comprehensive overview and professional assistance regarding the MD5 license, you can refer to this article: MD-5 License Class A&B Medical Devices

Conclusion

In a highly regulated field such as manufacturing medical devices, having expert guidance can make the path to attaining a manufacturing license much smoother and efficient. For any further assistance or consultation regarding the licensing process, reach out to Pharmadocx Consultants. You can give them a call at +91-7404557227 or send an email to [email protected]

Regulated manufacturing processes ensure we have safe and effective medical devices like the Stereotactic neuronavigation/planning system on the market. By adhering to the rules and regulations set by organizations like the CDSCO, manufactures contribute significantly to the healthcare sector in India.

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