CDSCO Manufacturing License for Deep brain electrical stimulation system lead

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the quality control, regulation, and standardization of drugs and medical devices in India¹. Ensuring that medical devices adhere to the strictest standards, CDSCO is the bedrock of safety for patients in need of medical intervention. Among the various responsibilities bestowed upon CDSCO, the issuance of manufacturing licenses for medical devices, such as the Deep brain electrical stimulation system lead, is a critical duty that ensures the credibility of medical products. The manufacturing licence allows for the regulation of prodcuction standards, ensuring a high quality medical device industry supporting patient health care.

The Deep Brain Electrical Stimulation System Lead (DBESSL) is a pivotal medical device used in conjunction with a deep brain electrical simulation system. Deep brain stimulation is a medical procedure used to treat neurological conditions like Parkinson's disease. The lead used in these systems plays a crucial role in the delivery of electrical impulses to the brain, which help to control the symptoms of these conditions. The CDSCO's official portal provides a wealth of information on the regulation of medical devices in India. You can visit this site to learn more here.

• What is Deep brain electrical stimulation system lead?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Deep brain electrical stimulation system lead
• Fees for manufacturing license for Deep brain electrical stimulation system lead
• Why is a Manufacturing License Necessary for Deep brain electrical stimulation system lead?
• Steps to Obtain a CDSCO Manufacturing License for Deep brain electrical stimulation system lead
• Frequently Asked Questions (FAQs)
• Conclusion

What is Deep brain electrical stimulation system lead?

A Deep Brain Electrical Stimulation System Lead (DBESSL) is a critical component of a deep brain stimulation system. It is a thin insulated wire that is used to deliver electrical signals from a pulse generator to specific regions in the brain². The lead usually has multiple electrodes that allow for a targeted delivery of impulses, aimed at reducing motor symptoms such as tremor, rigidity, and bradykinesia often found in patients with neurological disorders like Parkinson’s disease, essential tremor, and dystonia³.

The Role of CDSCO in Medical Device Regulation

Established with a mandate to safeguard and ensure the quality of drugs and medical devices in India, CDSCO provides a robust regulatory framework for medical devices. As part of its mission, CDSCO classifies medical devices into different risk categories and regulates their manufacture and sale within the country. The organization’s regulatory framework ensures that all medical devices, including a DBESSL, meet certain quality and safety standards before they are made available to patients.

How to manufacture Deep brain electrical stimulation system lead

Fees for manufacturing license for Deep brain electrical stimulation system lead

As a Class C device, the manufacturing license required for the DBESSL is the MD9. The fees associated with the MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Deep brain electrical stimulation system lead?

• It's a legal requirement to manufacture a medical device in India⁴.
• Ensuring quality and safety in medical device production⁵.
• Regulatory compliance plays a major role in the effectiveness of the healthcare sector.
• It prevents subpar products from reaching patients, thereby protecting their health.

Steps to Obtain a CDSCO Manufacturing License for Deep brain electrical stimulation system lead

These steps include:

1. Submitting the necessary documentation such as the Device Master File, Quality Management Certificate, Device Details, Site details.
2. Submitting the application to the relevant licensing authority.
3. Processing and review of the application by CDSCO.
4. Issuance of the license if all requirements are met.

Frequently Asked Questions (FAQs)

Q. What is risk class of Deep brain electrical stimulation system lead as per Medical Device Rules, 2017?
A. Deep brain electrical stimulation system lead is considered a Class C device under the Medical Device Rules, 2017.

Q. What license is needed to manufacture Deep brain electrical stimulation system lead?
A. The MD9 licence is required to manufacture the Deep brain electrical stimulation system lead.

Q. What is the fee for the MD9 license for Deep brain electrical stimulation system lead?
A. The fee for the MD9 license for a Deep brain electrical stimulation system lead is Rs. 50,000, with an additional Rs. 1,000 per product.

Q. Who will issue the manufacturing license for Deep brain electrical stimulation system lead?
A. For class C devices like the Deep brain electrical stimulation system lead, the CDSCO Headquarters in New Delhi will issue the license.

Q. Is repackaging of Deep brain electrical stimulation system lead considered manufacturing? A. Yes, under the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by definition, medical devices, is considered manufacturing. Therefore, repackaging of a Deep brain electrical stimulation system lead would require an MD9 license.

Conclusion

Regulations and licensing can be intricate and challenging without the right assistance. Do not hesitate to reach out to Pharmadocx Consultants for help navigating the complexities of obtaining your manufacturing license. You can reach them here, or call "+91-7404557227", or email "[email protected]" for more information. Reading on MD9 licensing can be pursued via this informative article.