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CDSCO Manufacturing License for Gastric sleeve

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the central drug authority in India, responsible for overseeing the quality, safety, and efficacy of drugs and medical devices available in the nation's market. One of CDSCO's core duties is to grant manufacturing licenses for medical devices. These licenses, a prerequisite for legally manufacturing any medical device in India, play a vital role in ensuring quality control and maintaining high safety standards in the Indian healthcare industry.

The focus of this blog post is the Gastric Sleeve, a medical device whose manufacturing necessitates a CDSCO issued license. Gastric sleeve is a transformational medical device used extensively in the field of gastroenterology to assist patients in their weight loss journey. For more information about medical devices and their licensing in India, refer to CDSCO's portal here.

What is a Gastric Sleeve?

Gastric sleeve, technically known as sleeve gastrectomy, is a medical device that alters the shape and size of the stomach. It is a sterile implant that wraps around the stomach's proximal portion, reducing its volume. Its targeted users are overweight or obese patients who wish to lose weight. The gastric sleeve functions by limiting the quantity of food intake and inducing a sense of satiety (fullness), thus facilitating weight loss.

This revolutionary device has found widespread use in treating obesity, playing a vital part in bariatric surgeries worldwide.

The Role of CDSCO in Medical Device Regulation

Born out of a pressing need to regulate the manufacture and sale of drugs and medical devices, CDSCO plays a crucial role in maintaining the health and safety standards in India's healthcare sector. It functions under the ambit of India's Ministry of Health and is empowered to grant permits, licenses and regulate the drug and medical device sector.

When it comes to medical devices, CDSCO has established a robust regulatory framework comprising medical device classifications and licensing requirements tailored to each class.

How to manufacture a Gastric Sleeve

The manufacturing process of a Gastric Sleeve involves several stages, each requiring rigorous standard compliances and quality checks. These include design, prototyping, mass production, packaging, and sterilization. Moreover, it's crucial to comply with the regulatory norms, including obtaining the necessary manufacturing license from CDSCO, before commencing the manufacturing process.

Fees for manufacturing license for a Gastric Sleeve

Given that the Gastric Sleeve falls under the risk class C, the corresponding license required is MD9. The fees for an MD9 license comprise a license fee of Rs. 50,000 and an additional Rs. 1,000 per product. For an in-depth understanding of an MD9 license, follow this [link].(https://pharmadocx.com/cdsco-md9-manufacturing-license-consultant-for-medical-devices-in-india/)

Why is a Manufacturing License Necessary for a Gastric Sleeve?

The manufacturing license is a non-negotiable regulatory legal requirement for the production of any medical device, including the Gastric Sleeve. This license acts as a guarantor of the product's quality and safety. Therefore, it's crucial for manufacturers to be in compliance with CDSCO's regulations to protect consumers from deficient products and uphold the healthcare industry's high ethical and professional standards.

Steps to Obtain a CDSCO Manufacturing License for a Gastric Sleeve

Described below are the main stages involved in acquiring a manufacturing license.

  1. Compilation of required documentation like Device Master File, Quality Management Certificate, Device Details, Site details.
  2. Submission of the application with CDSCO.
  3. Rigorous reviewal by CDSCO.
  4. Final approval of licence, if compliance with all requirements is achieved.

Given the intricacies of the process, several challenges like incomplete documentation, not adhering to quality standards, or not meeting safety parameters may arise. However, thorough preparation and professional assistance can help overcome these hurdles.

Frequently Asked Questions (FAQs)

  • Q1: What is the risk class of a Gastric Sleeve as per Medical Device Rules, 2017?
    A1: Gastric Sleeve falls under risk class C.

  • Q2: What license is needed to manufacture a Gastric Sleeve?
    A2: To manufacture a Gastric Sleeve, an MD9 license is necessary.

  • Q3: What is the fee for an MD9 license for a Gastric Sleeve?
    A3: The fees for an MD9 Manufacturing License amount to Rs. 50,000, plus Rs. 1,000 per Gastric Sleeve product.

  • Q4: Who will issue the manufacturing license for a Gastric Sleeve?
    A4: For a Gastric Sleeve, which falls under risk class C, the license will be issued by the CDSCO HQ in New Delhi.

  • Q5: Is repackaging of a Gastric Sleeve considered manufacturing?
    A5: Yes, the Drugs and Cosmetics Act defines repackaging as a form of manufacturing. This definition extends to repackaging of a Gastric Sleeve as well, thereby necessitating an MD9 license.

Conclusion

While pursuing the license can seem daunting, expert guidance can streamline the process significantly. For assistance with your licensing endeavor, reach out to Pharmadocx Consultants, call on +91-7404557227 or email at [email protected] for comprehensive and reliable consultants.

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