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CDSCO Manufacturing License for Implantable gastric clamp

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary pharmaceutical and medical device regulatory authority. Its main functions include ensuring the quality, safety, and efficacy of drugs and devices sold in India. Manufacturing licenses for medical devices play an integral role by ensuring that medical device manufacturers meet stringent quality and safety standards. The manufacturing license serves as proof of regulatory compliance, which is crucial to operate in the healthcare sector, and essentially, protect patients from substandard medical devices.

One such medical device that requires a CDSCO Manufacturing License is the Implantable Gastric Clamp, a critical medical device used to facilitate weight loss in overweight/obese patients. This blog post provides a comprehensive understanding of the CDSCO, its regulatory framework, the role of manufacturing licenses, and the process of obtaining one for the Implantable Gastric Clamp.

To get more detailed information about CDSCO and its activities, you may visit their portal here.

What is an Implantable Gastric Clamp?

An Implantable Gastric Clamp is a sterile device designed to isolate the lesser curvature segment of the stomach, the 'magenstrasse'. Its primary purpose is to reduce stomach volume and thereby facilitate weight loss in overweight or obese patients. The device operates on the mechanism of reducing food consumption by increasing the patient's sense of fullness or satiety.

This device plays a significant role in the field of gastroenterology and obesity management, helping patients deal with weight issues that may be detrimental to their health.

The Role of CDSCO in Medical Device Regulation

CDSCO has a rich history and pivotal role in ensuring the standardization of drugs and medical devices in India. It is accountable for protecting and promoting public health, fostering innovation, and contributing to the country's economic advancement.

CDSCO's regulatory framework is comprehensive and robust, ensuring medical device manufacturers strictly adhere to the highest levels of quality, safety, and efficacy. The organization regularly revises and updates its regulatory guidelines to stay up-to-date with technological advancements and international standards.

How to Manufacture Implantable Gastric Clamp

Manufacturing of the Implantable Gastric Clamp needs a comprehensive understanding of medical device design, material science, and regulatory compliance. Additionally, with the device being classified under the risk Class C, it requires a stringent process of quality assurance and regulatory adherence.

Fees for Manufacturing License for Implantable Gastric Clamp

For an Implantable Gastric Clamp, which falls under Risk Class C, a MD9 manufacturing license is necessary. The fee for the MD9 license is Rs 50,000 for the license and Rs 1000 per product category.

Why is a Manufacturing License Necessary for Implantable Gastric Clamp?

Obtaining a manufacturing license for an Implantable Gastric Clamp ensures the device meets all quality and safety standards mandated by the CDSCO. This license showcases the manufacturer's commitment to regulatory compliance, ensuring product safety and safeguarding patients from substandard or harmful medical devices.

Steps to Obtain a CDSCO Manufacturing License for Implantable Gastric Clamp

  1. Gathering requisite documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submitting the application to CDSCO for examination.
  3. Waiting for the approval, ensuring close interaction and cooperation with the regulatory authorities.
  4. Overcoming any potential hurdles during the approval process.

For detailed instructions on obtaining an MD9 license, visit Pharmadocx's article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Implantable Gastric Clamp as per Medical Device Rules, 2017?
The Implantable Gastric Clamp falls under Risk Class C.

Q2. What license is needed to manufacture Implantable Gastric Clamp?
To manufacture the Implantable Gastric Clamp, an MD9 license is required.

Q3. What is the fee for an MD9 license for Implantable Gastric Clamp?
The fee for an MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product category.

Q4. Who will issue the manufacturing license for Implantable Gastric Clamp?
The CDSCO HQ in New Delhi will issue the license to manufacture Implantable Gastric Clamp (Class C device).

Q5. Is repackaging of Implantable Gastric Clamp considered manufacturing?
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. Therefore, repackaging of the Implantable Gastric Clamp is also considered manufacturing requiring an MD9 license.

Conclusion

Navigating the process of obtaining a manufacturing license can be intricate and overwhelming. Consulting experts from Pharmadocx can simplify the process for you. Connect with our consultants for comprehensive assistance regarding the licensing process. Visit our website Pharmadocx Consultants, call us at +91-7404557227, or drop an email to [email protected] for a seamless experience.

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