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CDSCO Manufacturing License for Gastrointestinal endoscopic clip applier

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the central drug authority in India for the regulation of pharmaceuticals and medical devices. The organization ensures the quality, safety, and performance of these products. In the burgeoning medical device industry, manufacturing licenses hold paramount importance. They ensure the product meets the standards and regulations set forth by CDSCO in terms of quality, safety, and efficacy.

We take this opportunity to introduce the Gastrointestinal endoscopic clip applier, a critical medical device used in gastroenterology. This blog provides insights into the CDSCO's regulations surrounding its manufacturing licenses and focuses on CDSCO's pivotal role in controlling and regulating medical devices.

Visit the CDSCO's portal here for more information.

What is Gastrointestinal endoscopic clip applier?

Gastrointestinal endoscopic clip applier is a medical device used in conjunction with a compatible flexible endoscope. Its main purpose is to apply a gastrointestinal endoscopic clip to the mucosal lining of the GI tract during an endoscopic procedure.

This device is typically used for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and treating mucosal/submucosal defects. It provides medical professionals with accurate control over the application of such clips, ensuring effectiveness and safety in a multitude of endoscopic procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO, established under the Drugs and Cosmetics Act, 1940, is the national regulatory authority responsible for ensuring the safety, performance and quality of pharmaceuticals and medical devices in India. The organization's mission is to safeguard and enhance public health by ensuring the quality of the medical devices used in the healthcare sector.

CDSCO's regulatory framework for medical devices includes categorizing them into different risk levels - Class A to Class D, with D being the highest risk.

How to manufacture Gastrointestinal endoscopic clip applier

The manufacturing process of a Gastrointestinal endoscopic clip applier involves quality controls, robust engineering, and adherence to safety norms and guidelines outlined by CDSCO. The device belongs to risk Class B hence requires a standard set of guidelines for its manufacturing.

Fees for manufacturing license for Gastrointestinal endoscopic clip applier

For Class B devices, such as the Gastrointestinal endoscopic clip applier, the required license is MD5. The fees for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product. You can get more information about these fees here.

Why is a Manufacturing License Necessary for Gastrointestinal endoscopic clip applier?

Owing to its risk category, it is mandatory for a Gastrointestinal endoscopic clip applier to have a manufacturing license. The manufacturing license ensures quality control, safety, and regulatory compliance, allowing consumers and patients a sense of trust and reliability on the product.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal endoscopic clip applier

To obtain the manufacturing license, you require a set of pre-requisites and documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.

  1. Submission of the application and required documents.
  2. Verification and quality checks by the designated authorities.
  3. Resolution of queries, if any, and re-submission if required.
  4. Approval of license after thorough documentation check and quality control audit.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Gastrointestinal endoscopic clip applier as per Medical Device Rules, 2017?

The Gastrointestinal endoscopic clip applier falls in risk class B as per the Medical Device Rules, 2017.

Q2: What license is needed to manufacture Gastrointestinal endoscopic clip applier?

The MD5 license is required to manufacture Gastrointestinal endoscopic clip applier.

Q3: What is the fees for MD5 license for Gastrointestinal endoscopic clip applier?

The fees for an MD5 license for Gastrointestinal endoscopic clip applier is Rs. 5,000 for the license and Rs. 500 per product.

Q4: Who will issue the manufacturing license for Gastrointestinal endoscopic clip applier?

For Class B devices like Gastrointestinal endoscopic clip applier, the state FDA will issue the license.

Q5: Is repackaging of Gastrointestinal endoscopic clip applier considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices are also considered drugs under this act, implying that repackaging of Gastrointestinal endoscopic clip applier would require an MD5 license.

Conclusion

Obtaining licensing for medical devices is a critical step in product development, ensuring the safety and efficacy of your device. To navigate through the many regulations and procedures that come along with this process, a consultation with experts is advisable. Contact us at Pharmadocx Consultants or call us at +91-7404557227. Alternatively, they can reach us via email at [email protected]. We provide professional assistance tailored to your needs and queries to help simplify the licensing process.

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