Published on

CDSCO Manufacturing License for Endoscopic motorized cutting stapler, single-use

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO), under the aegis of the Ministry of Health and Family Welfare, plays a pivotal role in the medical device industry in India. It is the go-to authority responsible for the approval and standardization of drugs and medical devices. One critical aspect of the organization's role is the issuance of manufacturing licenses – a mandate every medical device company must fulfill prior to launching their products into the market.

Our focus in this piece is on Endoscopic Motorized Cutting Stapler, a unique medical device that's incredibly significant in the healthcare landscape, particularly in the field of gastroenterology. While we delve furtherinto this topic, we must remind our readers to always keep the CDSCO's portal (https://cdscomdonline.gov.in/NewMedDev/Homepage) handy for direct information and updates.

What is Endoscopic Motorized Cutting Stapler?

An Endoscopic Motorized Cutting (EMC) Stapler is a state-of-the-art medical device designed to aid healthcare professionals in surgical procedures. Its primary function is to carry out speedy transection and resection of tissues, making it instrumental during endoscopic surgical procedures for creating anastomoses. This device is single-use and sterile, ensuring safety and high quality in every single application.

Common procedures involving this innovative device include gastrointestinal surgeries where it aids in the removal and repair of body parts such as the stomach and intestines. Its significance stems from its efficiency and reliability in aiding the completion of such intricate operations.

The Role of CDSCO in Medical Device Regulation

Founded in the post-independence era, CDSCO's mission has always been to meet public health objectives by ensuring the quality, safety, and efficacy of drugs and medical devices in India. In terms of medical devices, it takes the lead role in defining regulatory standards and protocols, all of which fall under the Medical Device Rules, 2017.

CDSCO’s regulatory framework for medical devices is robust, accounting for risk classification - a method of evaluating the potential risks medical devices might pose. In a nutshell, CDSCO is the backbone of the medical device industry’s regulatory landscape in India.

How to Manufacture the Endoscopic Motorized Cutting Stapler

The intricate process of manufacturing an Endoscopic Motorized Cutting Stapler involves adhering to stringent standards and regulations as set by the CDSCO and other global entities. These standards determine the Endoscopic Motorized Cutting Stapler's design, production, testing, and validation before it's deemed safe for hospital use.

To legally manufacture this device, a company requires an MD5 manufacturing license issued by the State FDA, given that an Endoscopic Motorized Cutting Stapler is a Class B device.

Fees for Manufacturing License for Endoscopic Motorized Cutting Stapler

As per CDSCO's guidelines, the cost for acquiring an MD5 license stands at Rs. 5000, with an additional fee of Rs. 500 per product. Consequently, manufacturers of the Endoscopic Motorized Cutting Stapler must bear this cost to legally carry out their operations.

To gather information on the license application process and more about MD5 license, you can read here MD5 License details.

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

Obtaining a manufacturing license is more than just a legal obligation. It is a testament to the manufacturer's commitment to quality, safety and regulatory compliance in healthcare.

The significance of regulatory compliance permeates every sector, and in healthcare, it protects consumers and patients from substandard products. This importance is accentuated in the context of medical devices like the Endoscopic Motorized Cutting Stapler, which directly impact a patient's health and wellbeing.

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

For obtaining the manufacturing license, a manufacturer needs to provide documentation such as, Device Master File, Quality Management Certificate, Device Details, Site details and more.

The application process is straightforward, involving submission of the application, evaluation, inspection and finally, approval. In each step, specific challenges might surface, but don't be dismayed. Seek professional assistance to ensure you navigate the process seamlessly.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Endoscopic Motorized Cutting Stapler as per Medical Device Rules, 2017?
A1: The Risk class of Endoscopic Motorized Cutting Stapler is 'Class B'.

Q2: What license is needed to manufacture Endoscopic Motorized Cutting Stapler?
A2: MD5 license is needed to manufacture Endoscopic Motorized Cutting Stapler.

Q3: What is the fees for MD5 license for Endoscopic Motorized Cutting Stapler?
A3: The fees for MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Q4: Who will issue manufacturing license for Endoscopic Motorized Cutting Stapler?
A4: For Class B devices like the Endoscopic Motorized Cutting Stapler, the State FDA will issue the MD5 license.

Q5: Is repackaging of Endoscopic Motorized Cutting Stapler considered manufacturing?
A5: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, which also includes medical devices, is considered manufacturing. Therefore, repackaging of Endoscopic Motorized Cutting Stapler requires an MD5 license.

Conclusion

Understanding and navigating the intricacies of acquiring a CDSCO manufacturing license can be a daunting task. However, assistance is only a call away. Pharmadocx Consultants specialize in consultancy and assistance regarding such matters. You can get in touch by visiting their website "Pharmadocx Consultants" or directly calling them on "+91-7404557227". You can also shoot an email at [email protected] for any queries.

cdsco import license in india banner
cdsco manufacturing license in india banner