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CDSCO Manufacturing License for Gastrointestinal anastomosis coupler, non- bioabsorbable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's foremost regulatory body concerned with ensuring the quality, safety, and efficacy of drugs and medical devices within the nation. It governs the approval of new drugs and clinical trials, regulates pharmaceutical and medical device imports and exports, and supervises drug standards across the country.

In the medical device industry, manufacturing licenses hold utmost significance. They are a measure of authenticity, certifying that the device manufacturer meets all required standards and regulatory compliances. For a device as critical as a Gastrointestinal anastomosis coupler, non-bioabsorbable, obtaining a manufacturing license is a keystone step towards bringing the product into the market.

To learn more about CDSCO and its regulatory frameworks, one can visit the official CDSCO portal - CDSCO's Website

What is Gastrointestinal Anastomosis Coupler, Non-Bioabsorbable?

A Gastrointestinal Anastomosis Coupler, non-bioabsorbable, is a surgical instrument designed to perform anastomosis, or the reconnection of two previously connected biological structures. It is frequently utilized in gastroenterology to link parts of the digestive system together after surgical resection. The device acts as an alternative to manual suturing, simplifying the process and reducing the risk of leakage and other complications.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been instrumental in the regulation of drugs and medical devices in India. Its commitment is to safeguard public health by assuring safety, efficacy, and quality of drugs, cosmetics, and medical devices. It oversees the regulatory framework for medical devices, ensuring that manufacturers adhere to the highest quality standards

How to manufacture Gastrointestinal Anastomosis Coupler, Non-Bioabsorbable?

Manufacturing of the Gastrointestinal Anastomosis Coupler involves detailed planning, meticulous execution, and thorough quality checks. It commences with designing the device, which includes detailing its specifications and guidelines for its use. The device is then assembled and tested rigorously for safety, functionality, and effectiveness. The entire process requires seeking approvals, meeting quality standards, and abiding by legal and ethical regulations as per the CDSCO.

Fees for Manufacturing License for Gastrointestinal Anastomosis Coupler, Non-Bioabsorbable

For manufacturing a Gastrointestinal Anastomosis Coupler, a Class C device, an MD9 License is required. The fees for obtaining this license amount to Rs. 50,000, with an additional charge of Rs. 1,000 per product. For more details on the MD9 license, you can visit this link

Why is a Manufacturing License Necessary for Gastrointestinal Anastomosis Coupler, Non-Bioabsorbable?

A manufacturing license is indispensable for the production of the Gastrointestinal Anastomosis Coupler. It proves that the manufacturing unit adheres to the prescribed quality and safety standards. Regulatory compliance in the healthcare industry is of paramount importance as it directly affects the health and wellbeing of patients. A license also protects consumers and patients from substandard and harmful products.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal Anastomosis Coupler, Non-Bioabsorbable

  1. Procure necessary documents including the Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit these documents alongside the application for the MD9 license.
  3. Await approval, which is dependent on the thorough verification of the documents submitted.
  4. Cope with any challenges by staying updated with the regulations and consulting experts or authorized bodies.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gastrointestinal Anastomosis Coupler as per Medical Device Rules, 2017?

Class C is the risk class of Gastrointestinal Anastomosis Coupler in accordance with the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Gastrointestinal Anastomosis Coupler?

An MD9 license is required for manufacturing Gastrointestinal Anastomosis Coupler.

Q3. What is the fees for an MD9 license for Gastrointestinal Anastomosis Coupler?

The fees for an MD9 license is Rs. 50,000 for the license, with an additional charge of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Gastrointestinal Anastomosis Coupler?

For the Gastrointestinal Anastomosis Coupler, a Class C device, the CDSCO Headquarters in New Delhi will issue the manufacturing license.

Q5. Is repackaging of Gastrointestinal Anastomosis Coupler considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by extension, medical devices, is considered manufacturing. Hence, repackaging of Gastrointestinal Anastomosis Coupler requires an MD9 license.

Conclusion

The ordeal of procuring a manufacturing license for a medical device can be intimidating, but we, at Pharmadocx Consultants, are here to offer you advice and assistance through this process. Reach out to us through our website Pharmadocx Consultants, call us on +91-7404557227 or email us at [email protected] for consultation and help with the licensing process.

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