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CDSCO Manufacturing License for Pharyngeal electrical stimulation catheter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a cornerstone of India’s healthcare sector, responsible for the approval of drugs, diagnostics, vaccines and medical devices for the entire nation. It serves as the focal point for pharmaceutical companies seeking to participate in the vast Indian medical market. In the medical device industry, manufacturing licenses play a crucial role as they help ensure standardized production of devices and thus, the safety of the patients. We will be focusing on one particular medical device, namely Pharyngeal Electrical Stimulation Catheter, and explore its medical significance. For details about CDSCO, you can visit their portal here

What is a Pharyngeal Electrical Stimulation Catheter?

A Pharyngeal Electrical Stimulation (PES) catheter is a sterile, flexible tubular device, specifically intended for the treatment of neurogenic dysphagia. This catheter delivers electrical stimulation to the pharyngeal muscles, which helps mitigate the swallowing issues caused due to neurogenic dysphagia. In many medical procedures related to the throat, PES catheters play a crucial role.

The Role of CDSCO in Medical Device Regulation

Forming a part of the Ministry of Health and Family Welfare, the CDSCO has been entrusted with the responsibility of regulating the medical device industry in India, striving towards safeguarding and enhancing public health in the country. The regulatory framework established by CDSCO plays a pivotal role in ensuring the availability of safe, reliable, and quality medical devices, including the Pharyngeal Electrical Stimulation Catheter.

How to manufacture a Pharyngeal Electrical Stimulation Catheter

The manufacturing process for a PES catheter involves meticulous planning and adherence to global manufacturing standards. These include sterilization and packaging, ensuring electrical stimulation functionality, biocompatibility, and compliance with other relevant medical device norms and regulations.

Fees for manufacturing license for a Pharyngeal Electrical Stimulation Catheter

Given that a Pharyngeal Electrical Stimulation Catheter is a Class C medical device, the required license is MD9. The license fee for MD9 amounts to Rs. 50,000 with an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Pharyngeal Electrical Stimulation Catheter?

Obtaining a manufacturing license is mandatory for any medical device. This license guarantees quality and safety in the production of the Pharyngeal Electrical Stimulation Catheter. Regulatory compliance in the healthcare sector is of utmost significance, as it protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Pharyngeal Electrical Stimulation Catheter

The process to obtain a manufacturing license includes requirements such as a Device Master File, Quality Management Certificate, Device Details and Site details. Once the proper documentation is compiled, the application process begins, which involves submission and approval stages. Throughout the process, challenges may arise and can be overcome with due diligence.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Pharyngeal Electrical Stimulation Catheter as per Medical Device Rules, 2017? Class C.

Q2. What license is needed to manufacture a Pharyngeal Electrical Stimulation Catheter? MD9 license is needed to manufacture a Pharyngeal Electrical Stimulation Catheter.

Q3. What is the fee for an MD9 license for a Pharyngeal Electrical Stimulation Catheter? Fee for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for a Pharyngeal Electrical Stimulation Catheter? For a Class C device like PES Catheter, CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of the Pharyngeal Electrical Stimulation Catheter considered manufacturing? 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 Pharyngeal Electrical Stimulation Catheter is also considered manufacturing requiring a license on MD9.

Get more details on MD9 here.

Conclusion

Understanding the intricacies of obtaining a manufacturing license for medical devices from CDSCO can be a challenging endeavor. However, professionals, such as us at Pharmadocx Consultants, can assist and simplify this process. Feel free to reach out to us for consultation or assistance regarding the licensing process. You can also call us at +91-7404557227 or email us at [email protected]. We are eager to help you navigate through the CDSCO licensing process efficiently.

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