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CDSCO Manufacturing License for Vacuum-powered body fluid suction apparatus.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's central regulatory body for Pharmaceuticals and Medical Devices. The CDSCO is tasked with safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It's pivotal in the regulatory process, licensing, trials, and marketing approval.

The medical device industry, vast and pivotal, is heavily regulated to ensure product integrity for patient safety. Manufacturing licenses, hence, serve as a stamp of safety, assuring the product's quality meeting the necessary standards.

In this article, I will illuminate the clinical importance of a medical device named Vacuum-powered body fluid suction apparatus and shed light on the regulatory aspects involving its manufacture.

What is Vacuum-powered body fluid suction apparatus?

A Vacuum-powered body fluid suction apparatus is an integral medical device used in various medical and surgical procedures. Its primary function is to aspirate, remove or sample body fluids.

Deployed extensively in surgeries to keep the surgical site clear and in clinics to aid in fluid withdrawal, vacuum-powered body fluid suction apparatus has become an essential arsenal in a physician's repertoire.

The Role of CDSCO in Medical Device Regulation

CDSCO, over time, has emerged as the protector of the consumer's interests by establishing an effective, transparent, and accountable regulatory framework. The mission of CDSCO is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

To regulate the medical devices industry, CDSCO has a well-defined regulatory framework. It includes stringent checks for licenses, clinical trials, and marketing approval of these medical devices.

How to manufacture Vacuum-powered body fluid suction apparatus

Manufacturing a Vacuum-powered body fluid suction apparatus involves several technical aspects, abided by the regulations provided by governing authorities. Adherence to quality standards is fundamentally necessary for ensuring a safe and effective product.

Fees for manufacturing license for Vacuum-powered body fluid suction apparatus

Being classified under the risk class B, the manufacturing license required is MD5. The fee for obtaining MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Vacuum-powered body fluid suction apparatus?

Obtaining a manufacturing license is a regulatory obligation for manufacturing medical devices. It assures the device's quality and safety, protecting patients and consumers from substandard products and averts potential public health crises. Regulatory compliance is pivotal in the healthcare sector, and manufacturers must follow stringent regulations to ensure the safety and efficacy of their products.

Steps to Obtain a CDSCO Manufacturing License for Vacuum-powered body fluid suction apparatus

The process can be summarised into the following steps:

  1. Compilation of necessary documentation like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of the application along with the documents to the respective authority.
  3. Review and scrutiny of the application and documentation by regulatory bodies.
  4. Approval from the regulatory bodies post successful scrutiny.

Frequently Asked Questions (FAQs)

  1. Q:What is the risk class of the Vacuum-powered body fluid suction apparatus as per Medical Device Rules, 2017? A: Risk Class B.

  2. Q: What license in needed to manufacture Vacuum-powered body fluid suction apparatus? A: License MD5 is required.

  3. Q: What is the fees for MD5 license for Vacuum-powered body fluid suction apparatus? A: Rs. 5,000 for the license and Rs. 500 per product.

  4. Q: Who will issue the manufacturing license for Vacuum-powered body fluid suction apparatus? A: For Class A sterile and measuring & Class B devices, the state FDA will issue the license.

  5. Q: Is repackaging of Vacuum-powered body fluid suction apparatus considered manufacturing? A: Yes, repackaging of Vacuum-powered body fluid suction apparatus is considered manufacturing requiring a license on MD5.

Conclusion

Understanding and following the licensing process may seem intricate. However, expert advice and assistance can smoothen the ride. Reach out for reliable consultation to Pharmadocx Consultants or call +91-7404557227 or drop an email at [email protected].

For added assistance in understanding the licensing process for MD5, read here.

At Pharmadocx, we're committed to assisting you and making the process more accessible and comprehensible.

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