CDSCO Manufacturing License for Arthritis TENS system

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal drug regulatory authority in India which oversees the safety, performance, and quality of medicines, vaccines, and medical devices. The vital role that CDSCO plays is to ensure these medical products are effective and safe for the Indian population.

When it comes to the medical device industry, the role of manufacturing licenses cannot be overstated. These licenses are testament to the device meeting all the necessary regulatory standards, and therefore assures patients and healthcare providers of its safety and efficacy. One such device is the Arthritis Transcutaneous Electrical Nerve Stimulation (TENS) System.

The Arthritis TENS system holds great medical significance in the field of physiotherapy and rehabilitation practice. To learn more about the relevance of this device and its licensing process, visit the CDSCO's official portal here.

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

What is the Arthritis TENS system?

The Arthritis Transcutaneous Electrical Nerve Stimulation system (TENS) is designed to deliver mild electrical pulses across the skin, stimulating peripheral nerves and resulting in pain reduction and relief from stiffness associated with rheumatoid arthritis or osteoarthritis.

The TENS system is often utilized in physiotherapy, chiropractic, and other medical practices as an adjunct therapy and has gained popularity due to its non-invasive nature and its role in mitigating dependence on pharmaceuticals for pain relief.

The Role of CDSCO in Medical Device Regulation

The mission of the CDSCO is to guarantee the safety, efficacy, and quality of medical devices in India. CDSCO, under the Drugs and Cosmetics Act, is responsible for approval of licenses for the manufacturing of Class B medical devices such as the Arthritis TENS system.

CDSCO's regulatory framework for medical devices ensures thorough evaluation and control over the manufacturing, import, distribution, sale and use of these devices in India.

How to manufacture Arthritis TENS system

The manufacturing of the TENS system involves several crucial steps, starting from the design stage to the final production of the medical device. The process also involves rigorous testing and multiple quality checks to ensure the safety and efficacy of the device.

Fees for manufacturing license for Arthritis TENS system

For manufacturing a Class B medical device such as the Arthritis TENS system, an MD5 license is required. The fee for this license is Rs. 5,000, plus an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Arthritis TENS system

Obtaining a manufacturing license from CDSCO is mandatory for the manufacturing of a Class B device like the Arthritis TENS system. The license ensures that the manufacturing process adheres to stringent quality standards.

Regulatory compliance in the healthcare sector is of utmost importance to ensure patient safety, protect consumers from substandard products, and promote public trust in healthcare products.

Steps to Obtain a CDSCO Manufacturing License for Arthritis TENS system

1. Ensure all prerequisites, including documentation such as Device Master File, Quality Management Certificate, Device Details, and Site details, are in place.
2. Initiate the application process, involving submission and approval.
3. Be prepared to face some challenges and be ready with solutions.
4. Make sure to comply with all the regulatory requirements.

You can learn more about the MD5 license here.

Frequently Asked Questions (FAQs)

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

• The Arthritis TENS system falls under Risk Class B.

Q2. What license is needed to manufacture Arthritis TENS system?

• An MD5 license is required to manufacture the Arthritis TENS system.

Q3. What is the fees for MD5 license for Arthritis TENS system?

• The cost for an MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

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

• For Class B devices like the Arthritis TENS System, the state FDA will issue the license.

Q5. Is repackaging of Arthritis TENS system considered manufacturing?

• Yes, repackaging of the Arthritis TENS system is considered manufacturing, requiring an MD5 license.

Conclusion

Getting a manufacturing license from CDSCO is a crucial step in the production of any medical device in India, including the Arthritis TENS system. It can be a complicated process, but experts like Pharmadocx Consultants are ready to help. Reach out to Pharmadocx Consultants here or call them at +91-7404557227 or email them at [email protected] for guidance on your licensing journey.