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CDSCO Manufacturing License for Motorised Wheeled stretcher.

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Introduction

CDSCO, or Central Drugs Standard Control Organization, is the central regulatory authority in India for the endorsement and standardization of drugs, control over the quality of imported drugs, coordination of state-level regulatory bodies, and providing expert advice to the government on technical matters. One of its primary responsibilities is the regulation of medical devices, including their manufacturing, sales, and import.

Understanding the importance of manufacturing licenses in the medical device industry is crucial. It not only ensures the safety and efficacy of medical devices but also maintains the integrity of the industry by enabling regulatory authorities to maintain the standards and scrutinizing the manufacturing processes.

Let's delve into one such vital medical device, the Motorised Wheeled Stretcher, which plays an indispensable role in hospital settings and during emergencies. For more information, navigate to CDSCO's official portal here.

What is a Motorised Wheeled Stretcher?

A Motorised Wheeled Stretcher is a device designed to transport patients who are unable to move independently. This device is motorised, making it easier for healthcare professionals to transport patients around hospitals or emergency sites, reducing physical strain for both the patient and caregiver.

It is commonly used in various hospital procedures such as transporting patients to and from surgery, moving patients within a hospital or healthcare facility, and used extensively in emergency situations.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organisation (CDSCO) was instituted with the mission to safeguard and enhance public health in India. It is responsible for approving new medical devices, supervising clinical studies in India, laying down medical device standards, controlling the quality of imported devices, coordinating with state regulatory authorities, and advising the government on technical matters.

CDSCO has a robust regulatory framework for medical devices, which is based on the risk level associated with them. The framework ranges from Class A (Low Risk) to Class D (High Risk).

How to manufacture a Motorised Wheeled Stretcher?

Manufacturing a medical device as critical as a Motorised Wheeled Stretcher requires an appropriate license. For a device falling under risk Class B, an MD5 license is needed.

Fees for manufacturing license for Motorised Wheeled Stretcher

The fee for obtaining the MD5 license to manufacture a Motorised Wheeled Stretcher is Rs. 5000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Motorised Wheeled Stretcher?

Government regulation mandates the requirement of obtaining a license to manufacture medical devices, including the Motorised Wheeled Stretcher. This is done to ensure quality and safety in medical device production and to protect consumers and patients from potentially harmful or substandard products. Adherence to regulatory compliance in the healthcare sector is paramount as it directly impacts patient health and safety.

Steps to Obtain a CDSCO Manufacturing License for Motorised Wheeled Stretcher

Obtaining a manufacturing license involves the preparation and submission of requisite documents such as Device Master Files, Quality Management Certificate, Site Details, etc. The four-step process involves:

  1. Preparation of required documents.
  2. Submission of application along with necessary attachments to the concerned authority.
  3. Awaiting the approval.
  4. Dealing with any challenges or queries that may arise during the process.

For a comprehensive guide to obtaining an MD5 license, you can refer to this article here.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of a Motorised Wheeled Stretcher as per Medical Device Rules, 2017?

The risk class of a Motorised Wheeled Stretcher, as per Medical Device Rules, 2017, is Class B.

Q2: What license is needed to manufacture a Motorised Wheeled Stretcher?

An MD5 license is needed to manufacture a Motorised Wheeled Stretcher.

Q3: What is the fee for an MD5 license for a Motorised Wheeled Stretcher?

The fee for an MD5 license for a Motorised Wheeled Stretcher is Rs. 5000 for the license and Rs. 500 per product.

Q4: Who will issue the manufacturing license for Motorised Wheeled Stretcher?

For Class B devices such as the Motorised Wheeled Stretcher, the state FDA will issue the license.

Q5: Is the repackaging of a Motorised Wheeled Stretcher considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by extension, medical devices is considered manufacturing. Hence repackaging of a Motorised Wheeled Stretcher also requires an MD5 license.

Conclusion

Navigating the licensing procedure for manufacturing medical devices can be challenging. However, with the right consultation and assistance, this process will become effortless. If you're looking for professional help in obtaining a manufacturing license for the Motorised Wheeled Stretcher or any other medical devices, feel free to reach out to us at Pharmadocx Consultants. You can visit us at https://www.pharmadocx.com, call us at "+91-7404557227", or email to "[email protected]" for assistance.

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