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CDSCO Manufacturing License for Endoscopic motorized cutting stapler, reusable

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Introduction

Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals as well as medical devices. It ensures the quality of drugs and medical devices are up to standard, maintains stringent safety measures, and affirms the efficacy of the devices to protect the consumers. It is essential to have a proper manufacturing license under the CDSCO for production, import, and sale of these medical devices.

Manufacturing licenses are paramount in the medical device industry as they ensure the quality standardization, safety, and efficacy of the instruments meant for patient diagnosis, therapy, or surgery. The manufacturing license of CDSCO is a testament to the trustworthiness of the medical device at hand.

In this blog, we would be focussing on a particular medical device, the Endoscopic Motorized Cutting Stapler, reusable (henceforth referred to as EMCS). It is a significant surgical instrument that has revolutionized endoscopic surgical procedures.

For more information, visit the CDSCO's portal here.

What is the Endoscopic Motorized Cutting Stapler, reusable?

The EMCS is a hand-held, battery-powered surgical instrument used during endoscopic surgical procedures for quick tissue transection, resection of tissues, and creation of anastomoses. This instrument enhances surgical precision, reduces operation time, and aids in greater outcome efficiency.

The common procedures involving an EMCS include general surgery, thoracic surgery, bariatric surgery, and bowel anastomoses.

The Role of CDSCO in Medical Device Regulation

CDSCO has the vision to protect and promote public health in India. CDSCO has implemented a regulatory framework specifically for medical devices, which is divided into four classes (A, B, C, D) based on the associated risk.

How to manufacture Endoscopic Motorized Cutting Stapler, reusable

The production of the EMCS must comply with the regulations laid down by CDSCO. For devices classified under Risk Class B, such as the EMCS, the manufacturing license required is MD5.

Fees for manufacturing license for Endoscopic Motorized Cutting Stapler, reusable

The fees associated with obtaining an MD5 license for EMCS is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Motorized Cutting Stapler, reusable?

Obtaining a manufacturing license for the EMCS is mandatory, and it plays a crucial role in ensuring quality and safety in production by adhering to the set rules and guidelines. Being in concession with the regulatory compliance not only enhances trust within the healthcare sector but also prevents substandard products from entering the market, hence protecting consumers and patients.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Motorized Cutting Stapler, reusable

  1. Prepare all pre-requisites and documentation including Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit those documents.
  3. Approval review from CDSCO officials.
  4. If approved, receive the manufacturing license.

There are potential challenges during the application process. However, they can be overcome by creating a robust documentation process, ensuring the quality of the device, and having a thorough understanding of the regulations.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of Endoscopic Motorized Cutting Stapler, reusable as per Medical Device Rules, 2017?
    A: Endoscopic Motorized Cutting Stapler, reusable falls under Risk Class B.

  2. Q: What license is needed to manufacture Endoscopic Motorized Cutting Stapler, reusable? A: The manufacturing license required for Endoscopic Motorized Cutting Stapler, reusable is MD5.

  3. Q: What is the fees for MD5 license for Endoscopic Motorized Cutting Stapler, reusable?
    A: The fee is Rs. 5,000 for the license and Rs. 500 per product.

  4. Q: Who will issue the manufacturing license for Endoscopic Motorized Cutting Stapler, reusable?
    A: For Class B devices like Endoscopic Motorized Cutting Stapler, reusable, the state FDA will issue the license.

  5. Q: Is repackaging of Endoscopic Motorized Cutting Stapler, reusable considered manufacturing?
    A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Hence, repackaging of Endoscopic Motorized Cutting Stapler, reusable is also considered manufacturing requiring a license on MD5.

Conclusion

Considering the extensive procedure and the importance of the documentation in acquiring the CDSCO manufacturing license, professional guidance can be beneficial. Contact Pharmadocx Consultants for expert advice on this matter. You can also call them at +91-7404557227 or email them at [email protected].

Read this article to get a comprehensive understanding of the MD5 license: Here

Acquiring a manufacturing license can be a complicated process, but with the expert advice and guidance from Pharmadocx Consultants, it can be made much easier.

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