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CDSCO Manufacturing License for Endoscopic electrosurgical biopsy/resection kit, partial-thickness

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Introduction

Ever since its foundation, the Central Drugs Standard Control Organization, or CDSCO, has been a central figure in controlling and supervising the standard of drugs, cosmetics, diagnostics, and medical devices in India. It is the authoritative body that approves licenses for new drugs and clinical trials, lays down the standards for drugs, and supervises the market, protecting the consumer from inferior, dangerous devices, and medication.

Even in the medical device industry, CDSCO plays a pivotal role in screening and approving devices, ensuring they meet the necessary quality, safety, and efficacy standards. One such medically significant device is the Endoscopic electrosurgical biopsy/resection kit, which is critical to various medical procedures.

Interested parties can access more information about CDSCO and its protocols on their portal at https://cdscomdonline.gov.in/NewMedDev/Homepage.

What is an Endoscopic electrosurgical biopsy/resection kit?

The Endoscopic electrosurgical biopsy/resection kit is a collection of devices primarily intended for obtaining tissue biopsies during endoscopic procedures. These kits play a crucial role in therapeutic reduction of upper gastrointestinal (GI) tract tissue, typically implemented during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO is tasked with ensuring that every drug, cosmetic or medical device available in the market is safe, effective, and meets the highest standard of quality. The regulatory framework provided by CDSCO for medical devices ensures that manufacturing, marketing, and importation of these devices adhere to stipulated guidelines and standards.

How to manufacture an Endoscopic electrosurgical biopsy/resection kit

Manufacturing an Endoscopic electrosurgical biopsy/resection kit involves following stringent protocols as required by the governing body, CDSCO. Given the critical nature of this medical device, adherence to manufacturing norms is critical.

Fees for manufacturing license for an Endoscopic electrosurgical biopsy/resection kit

To manufacture an Endoscopic electrosurgical biopsy/resection kit, which falls into the 'C' risk class, an MD9 license is required. The fee for the MD9 license is Rs. 50,000, with an additional Rs. 1,000 fee levied per product.

Why is a Manufacturing License Necessary for an Endoscopic electrosurgical biopsy/resection kit?

The manufacturing license ensures that each device meets the stringent safety and quality parameters defined by the CDSCO. To ensure regulatory compliance, it is mandated to acquire the license before commencing the manufacturing process. This not only ensures quality in the production of medical devices but also protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for an Endoscopic electrosurgical biopsy/resection kit

  1. Documentation is a critical prerequisite, including details such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submitting an application via the CDSCO's online portal.
  3. The CDSCO reviews the application submitted and provides an approval following its satisfaction with the submitted documents, and post any necessary communication or visits.
  4. Even after approval, there may be challenges in managing the documentation and maintaining up-to-date records, which can be handled with the assistance of consultants.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Endoscopic electrosurgical biopsy/resection kit as per Medical Device Rules, 2017? The risk class of the Endoscopic electrosurgical biopsy/resection kit is 'C'.

Q2. What license is needed to manufacture an Endoscopic electrosurgical biopsy/resection kit? The MD9 license is required to manufacture an Endoscopic electrosurgical biopsy/resection kit.

Q3. What is the cost of an MD9 license for the Endoscopic electrosurgical biopsy/resection kit? The cost of an MD9 license is Rs. 50,000, with an additional fee of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for the Endoscopic electrosurgical biopsy/resection kit? For Class C & D devices, including the Endoscopic electrosurgical biopsy/resection kit, the CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of an Endoscopic electrosurgical biopsy/resection kit considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices, including the Endoscopic electrosurgical biopsy/resection kit, are also drugs. Hence, repackaging is considered manufacturing and requires a license on MD9.

Conclusion

To navigate through the complexities and regulatory procedures involved in obtaining a CDSCO manufacturing license, seek expert assistance. The team at Pharmadocx Consultants offers consultation and assistance regarding the licensing process.

Reach out to them at https://www.pharmadocx.com, call at +91-7404557227, or email to [email protected] for further details.

To understand the CDSCO's MD9 manufacturing license in-depth, refer to this article - https://pharmadocx.com/cdsco-md9-manufacturing-license-consultant-for-medical-devices-in-india/.

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