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CDSCO Manufacturing License for Deep-tissue electromagnetic stimulation system

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is primarily responsible for formulating standards and regulatory measures for drugs, cosmetics, diagnostic materials, and devices in the country. The CDSCO plays a significant role in ensuring the availability of safe, effective, and quality medical products to the public. A major part of these responsibilities includes the issuance of manufacturing licenses for medical devices.

Manufacturing licenses are of paramount importance in the medical device industry. They ensure manufacturers abide by the highest production standards and maintain the utmost quality of all medical devices. One such medical device is the Deep-tissue Electromagnetic Stimulation System, a key tool in rehabilitation medicine. You can find more information about the manufacturing process and regulations of medical devices like these on CDSCO's portal here.

What is Deep-tissue Electromagnetic Stimulation System?

A deep-tissue electromagnetic stimulation system is a medical device designed to apply an electromagnetic (EM) field to body tissues. It serves multiple purposes, such as treating musculoskeletal disorders like osteoarthritis and osteoporosis, relieving body pain, facilitating soft and hard tissue wound/injury healing, without the production of therapeutic deep heat.

The device has wide-ranging use in rehabilitation and physiotherapy, where it assists in alleviating pain and accelerating recovery.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been instrumental in medical device regulation in India. It has the crucial mission to ensure the safety, efficacy, and quality of medical devices available to the public. To accomplish this, it formulates guidelines and regulates the manufacturing, importing, and selling processes of medical devices.

CDSCO's regulatory framework for medical devices is structured into different risk classes (A, B, C, D) based on the potential risks associated with the use of the device. The deep-tissue electromagnetic stimulation system falls under Class B.

How to manufacture Deep-tissue Electromagnetic Stimulation System

Manufacturing a Deep-tissue Electromagnetic Stimulation System requires a Class B manufacturing license as per CDSCO regulations.

Fees for manufacturing license for Deep-tissue Electromagnetic Stimulation System

For manufacturing a Class B device like the Deep-tissue Electromagnetic Stimulation System, you'd require an MD5 license. The cost for this license is Rs. 5,000 and an additional Rs. 500 per product.

Please check out our detailed article on MD5 licenses here.

Why is a Manufacturing License Necessary for Deep-tissue Electromagnetic Stimulation System?

Obtaining a manufacturing license is compulsory for medical devices. It ensures the manufacturer maintains the highest quality and safety standards in the production process. Regulatory compliance in the healthcare sector is critical in protecting patients from receiving substandard products which could be harmful.

Steps to Obtain a CDSCO Manufacturing License for Deep-tissue Electromagnetic Stimulation System

  1. Prepare the necessary documents: Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit these documents along with the application form.
  3. After submission, the application will be reviewed for approval.
  4. After approval, the license will be issued by the State FDA for Class B devices.

Frequently Asked Questions (FAQs)

Q.1. What is risk class of Deep-tissue Electromagnetic Stimulation System as per Medical Device Rules, 2017?
A. The Deep-tissue Electromagnetic Stimulation System is classified as Class B as per the Medical Device Rules, 2017.

Q.2. What license is needed to manufacture Deep-tissue Electromagnetic Stimulation System?
A. MD5 license is required to manufacture a Deep-tissue Electromagnetic Stimulation System that falls in Class B category.

Q.3. What is the fee for MD5 license for Deep-tissue Electromagnetic Stimulation System?
A. The fee for MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Q.4. Who will issue manufacturing license for Deep-tissue Electromagnetic Stimulation System?
A. For Class A sterile and measuring & Class B devices like the Deep-tissue Electromagnetic Stimulation System, the state FDA will issue the license.

Q.5. Is repackaging of Deep-tissue Electromagnetic Stimulation System considered manufacturing?
A. 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 Deep-tissue Electromagnetic Stimulation System is also considered manufacturing requiring a license on MD5.

Conclusion

Applying for a CDSCO Manufacturing License can be a complex process. It requires an in-depth understanding of the medical device industry and the licensing process. If you require assistance in acquiring a manufacturing license for Deep-tissue Electromagnetic Stimulation System or any other medical devices, don't hesitate to reach out for consultation with Pharmadocx Consultants. You can do so via their website, call "+91-7404557227", or email "[email protected]".

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