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CDSCO Manufacturing License for Analgesic TENS system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the central regulatory body for pharmaceuticals and medical devices in India. Its primary function is to ensure the safety, effectiveness, and quality of drugs and medical devices available to the Indian public.

In the medical device industry, acquiring manufacturing licenses is a crucial step towards ensuring the production and distribution of high-quality, safe, and effective devices. This blog post will focus on the Analgesic TENS system, a Class B medical device used for treating pain via transcutaneous electrical stimulation on peripheral nerves.

For more detailed information, you can visit CDSCO's portal at https://cdscomdonline.gov.in/NewMedDev/Homepage.

What is an Analgesic TENS system?

A Transcutaneous Electrical Nerve Stimulation (TENS) system is a non-invasive, drug-free method of managing pain. The system sends small electrical pulses via adhesive pads attached to the skin, which can reduce or eliminate the perception of pain.

The Analgesic TENS system is commonly used in physical therapy, rehabilitation, and pain management procedures. It's a popular tool used to relieve pain from various conditions such as arthritis, sports injuries, and post-surgical recovery.

The Role of CDSCO in Medical Device Regulation

CDSCO, plays a central role in India's healthcare sector. As a government body, it's responsible for approving new drugs and regulating the quality of drugs and medical devices in the country.

Through its medical device regulatory framework, CDSCO ensures that medical devices produced and sold in India meet global safety and quality standards. The framework covers the manufacturing, import, sale, distribution, and usage of medical devices.

How to Manufacture an Analgesic TENS System

The manufacturing process of a TENS system class B device falls under the purview of CDSCO and requires an MD-5 manufacturing license.

Fees for Manufacturing License for Analgesic TENS System

The fees for obtaining an MD5 manufacturing license for Analgesic TENS system is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for an Analgesic TENS System?

Acquiring a manufacturing license is a mandatory process to ensure the production of quality and effective medical devices. The licensing process by CDSCO ensures that only high-standard medical devices are produced, safeguarding the health and well-being of patients.

Regulatory compliance carries significant weight in the healthcare sector. Violations can lead to severe penalties, product recalls, and harm to public health. A CDSCO license protects consumers from substandard medical devices, ensuring that they receive safe and quality healthcare.

Steps to Get a CDSCO Manufacturing License for Analgesic TENS System

  1. Prepare essential documents such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application with required documents.
  3. Await for CDSCO to review and approve your application.
  4. Overcome any hurdles by seeking expert consultation or assistance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Analgesic TENS system as per Medical Device Rules, 2017?

  • The Analgesic TENS system is a Class B medical device.

Q2. What license is needed to manufacture an Analgesic TENS system?

  • An MD5 license is required to manufacture an Analgesic TENS system.

Q3. What is the fee for an MD5 license for an Analgesic TENS system?

  • The fee for an MD5 license for an Analgesic TENS system is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for an Analgesic TENS system?

  • For Class B devices like Analgesic TENS system, the state FDA will issue the license.

Q5. Is repackaging of the Analgesic TENS system 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 Analgesic TENS system is also considered manufacturing requiring a license on MD5.

Conclusion

Taking your medical device from conceptualisation to mass production can be a daunting journey fraught with regulatory hurdles. As such, consulting with industry experts can greatly ease the process. If you're planning to manufacture medical devices such as the Analgesic TENS system, reach out to Pharmadocx Consultants, who are specialists in this field. You can call them directly at +91-7404557227 or send an email to [email protected] for more information. For more insights on the MD5 license, read this article - https://pharmadocx.com/md-5-licesne-class-a-b-medical-devices/.

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