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CDSCO Manufacturing License for Gas-powered surgical saw

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceutical and medical devices. It functions under the purview of the Ministry of Health & Family Welfare, Government of India and is primarily responsible for ensuring safety, efficacy, and quality of drugs, cosmetics, and medical devices marketed in India. In the realm of medical devices, one significant responsibility is the issuance of manufacturing licenses.

Manufacturing licenses are indispensable in the medical device industry. They validate the manufacturer’s adherence to the necessary regulatory standards and quality parameters. This determination is critical for patient safety and to ensure that the device is fit for its intended purpose. One such crucial device is the Gas-powered surgical saw. This surgical accessory holds great medical significance and its manufacture must comply with all relevant regulatory standards. For more information about this and other medical devices, visit the CDSCO’s portal here

What is a Gas-Powered Surgical Saw?

A Gas-powered surgical saw is a medical apparatus utilized in orthopedic and plastic surgeries. It is a handpiece which when attached facilitates vibration or reciprocal movements. The surgical saw is usually powered by compressed gases such as air or nitrogen making them an invaluable tool in various medical procedures.

These tools are commonly used in procedures such as limb amputations, long bone fractures, total joint replacements, and many more. Their precise cutting capabilities, coupled with the control it grants surgeons, makes them a necessary tool in these procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO, founded with the vision of safeguarding and enhancing public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices, has a long history and mission of healthcare regulation. In the medical devices industry, it employs a comprehensive supervisory framework to ensure that all devices comply with the necessary requirements.

The Central Drugs Standard Control Organization is also responsible for granting the licenses for the manufacture of medical devices. For the Gas-powered surgical saw, a Class B device, the license required is MD5.

How to Manufacture a Gas-Powered Surgical Saw

Manufacturing a Gas-powered surgical saw involves meeting the construction parameters required for the device and abiding by the relevant regulatory requirements. The manufacturing process needs to be approved by the regulatory authorities to assure the device's safety and performance in medical procedures.

Fees for Manufacturing License for Gas-Powered Surgical Saw

The fee for manufacturing a Gas-powered surgical saw, a Class B device, under the MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for a Gas-Powered Surgical Saw?

It is mandatory to obtain a manufacturing license for a Gas-powered surgical saw. It assures the quality and safety of the device and guarantees that the manufacturer complies with the regulatory standards of the CDSCO. This compliance is of utmost importance in the healthcare sector to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Gas-Powered Surgical Saw

  1. Preparation of the necessary documentation such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of the application and all supporting documents to the regulator.
  3. Await license approval after a thorough review.
  4. Overcoming potential challenges involves addressing any regulator concerns promptly and precisely.

Keep in mind that this is not a comprehensive guide to obtaining a license but a simple outline. To get complete details, consider seeking professional consultation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Gas-Powered Surgical Saw as per Medical Device Rules, 2017?

Ans: The Gas-powered surgical saw falls under Risk Class B.

Q2. What license is needed to manufacture a Gas-Powered Surgical Saw?

Ans: The license required for manufacturing a Gas-powered surgical saw is MD5.

Q3. What is the fee for the MD5 license for a Gas-Powered Surgical Saw?

Ans: The fee for the MD5 license is Rs. 5,000 and an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Gas-Powered Surgical Saw?

Ans: For the Gas-Powered Surgical Saw, a Class B device, the license will be issued by the state FDA.

Q5. Is repackaging of a Gas-Powered Surgical Saw considered manufacturing?

Ans: Yes. As per the Drugs and Cosmetics Act, repackaging of drugs is considered manufacturing, and therefore, repackaging of the Gas-powered surgical saw, which is considered a medical device under the Act, also requires a license. The Gas-powered surgical saw requires an MD5 license for manufacturing, which includes repackaging.

For detailed insights into obtaining a MD5 license, visit this link.

Conclusion

The process of obtaining a CDSCO manufacturing license for a Gas-powered surgical saw can be intricate and requires proper understanding of the regulatory landscape. If you require assistance in navigating these regulatory pathways, consider reaching out to the Pharmadocx Consultants, who can provide you with expert guidance. Visit their website, call at "+91-7404557227", or send an email to "[email protected]". They're equipped to provide end-to-end consultation regarding the licensing process, making it a streamlined and reliable experience for you. Don't hesitate to reach out!

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