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CDSCO Manufacturing License for Bed/chair electric massager

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's principal health authority responsible for the approval of new medicines and supervising the manufacture, sale, import, export, and distribution of drugs. CDSCO plays a critical role in ensuring the safety, quality, and efficacy of pharmaceuticals, vaccines, and medical devices available to patients. In the medical device industry, a manufacturing license is paramount, safeguarding the highest standards of quality and performance met.

This post will explore the Bed/chair electric massager, a unique medical device in the realm of rehabilitation that provides therapeutic treatment to patients suffering from body aches and pains. For more information and online licensing services, visit CDSCO's official portal CDSCO Online Authentication.

What is a Bed/chair electric massager?

A Bed/chair electric massager is a therapeutic device designed to alleviate body aches and discomfort by delivering electrically generated massage to the user. It is designed to be incorporated into a bed or chair, providing convenient access for individuals who need regular therapeutic massages.

Commonly, these devices are used to help relieve stress, reduce muscle tension, and improve blood circulation, contributing towards an individual's overall physical well-being.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the mandate of the Ministry of Health & Family Welfare, Government of India, is empowered to regulate the standard of drugs in the country. Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics, and medical devices.

Its regulatory framework for medical devices encompasses comprehensive guidelines, including everything from approving the device to licensing its production. The CDSCO classifies devices into different risk categories and mandates relevant licenses for manufacturing.

How to Manufacture a Bed/chair electric massager

Bed/chair electric massager production involves specific manufacturing guidelines to ensure its therapeutic effectiveness and user safety. Each massager must meet predefined safety and quality standards. For Class B devices, such as the bed/chair electric massager, an MD5 license is necessary for manufacturing.

Fees for manufacturing license for Bed/chair electric massager

For Class B, the relevant license is MD5. The manufacturing license fee for an MD5 license is Rs. 5,000, and for every product, an additional fee of Rs. 500 is charged. For more information on MD5 manufacturing license, refer to this article MD5 license.

Why is a Manufacturing License Necessary for Bed/chair electric massager?

A manufacturing license is mandatory for producing any medical device as it ensures quality and safety in production. Regulatory compliance is critical in healthcare, protecting patients and consumers from substandard products. In case of the Bed/chair electric massager, the manufacturing license guarantees that the device meets the necessary standards of safety and performance.

Steps to Obtain a CDSCO Manufacturing License for Bed/chair electric massager

  1. Gather necessary documents including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit your application to the concerned authorities.
  3. Await approval from the authority.
  4. Handle any issues or deficiencies identified by the authority, promptly and adequately.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Bed/chair electric massager as per Medical Device Rules, 2017?

  • The Bed/chair electric massager falls under Risk Class B.

Q2. What license is needed to manufacture Bed/chair electric massager?

  • An MD5 license is required for manufacturing Bed/chair electric massager.

Q3. What is fees for MD5 license for Bed/chair electric massager?

  • The license fee for MD5 is Rs. 5,000, and for each Bed/chair electric massager product, the additional fee is Rs. 500.

Q4. Who will issue manufacturing license for Bed/chair electric massager?

  • The state FDA will issue the license for Bed/chair electric massager.

Q5. Is repackaging of Bed/chair electric massager considered manufacturing?

  • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical Device Rules have been made under the provisions of Drug Act, hence repackaging of Bed/chair electric massager is also considered manufacturing requiring an MD5 license.

Conclusion

Regulatory licensing can be complex and cumbersome. If you need expert guidance for consultation or assistance with the licensing process for your Bed/chair electric massager, consider reaching out to the Pharmadocx Consultants. Feel free to visit "Pharmadocx" or call us at "+91-7404557227" or write to us at [email protected]. We're always ready to assist you with your medical device licensing needs.

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