Published on

CDSCO Manufacturing License for Video capsule endoscopy system capsule

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's principal health authority responsible for the regulation of medical devices and pharmaceuticals. The role of CDSCO in ensuring the safety and efficacy of medical devices is paramount. Proper licensing of these devices is crucial to ensure industry standards are upheld and patient safety is prioritized.

One such device that requires attention to these licensing procedures is the Video Capsule Endoscopy System Capsule. This modern medical invention has revolutionized the field of gastroenterology by providing a less invasive and more comfortable option for examining the gastrointestinal tract.

The CDSCO's portal, [https://cdscomdonline.gov.in/NewMedDev/Homepage], serves as an invaluable resource for manufacturers and healthcare professionals alike, offering guidance and regulatory information for all types of medical devices.

What is a Video Capsule Endoscopy System Capsule?

A Video Capsule Endoscopy System Capsule is a non-sterile, battery-powered, electronic device designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract. The capsule has a tiny camera that takes pictures of the digestive track as it passes through, with the images sent to a device worn on the patient’s belt for later review.

Common procedures involve diagnosis and monitoring of conditions such as gastrointestinal bleeding, Crohn's disease, and tumors of the small intestine. The capsule's small, digestible size and ability to transmit images wirelessly have made it a popular alternative to traditional, more invasive gastrointestinal diagnostic procedures.

The Role of CDSCO in Medical Device Regulation

Established over fifty years ago, the CDSCO is pivotal in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals in India. The organization also oversees clinical trials, establishes medical device guidelines, and monitors adverse events related to these products.

For medical devices like the Video Capsule Endoscopy System Capsule, the CDSCO's robust regulatory framework ensures that only products meeting specific safety and efficacy standards are available for patient care.

How to Manufacture a Video Capsule Endoscopy System Capsule

Involving modern electronics and biomedical engineering principles, manufacturing a Video Capsule Endoscopy System Capsule requires precision, quality control, and adherence to guidelines set by health authorities like the CDSCO.

Fees for Manufacturing License for Video Capsule Endoscopy System Capsule

For a Class B device like the Video Capsule Endoscopy System Capsule, a MD5 license is required. The fee for this license is Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Video Capsule Endoscopy System Capsule?

Securing a manufacturing license is mandatory for all medical device manufacturers. This not only ensures that the manufacturer meets quality and safety standards but also guarantees regulatory compliance in the healthcare sector. Furthermore, a license protects consumers and patients from substandard products, reinforcing the trust in healthcare provisions.

Steps to Obtain a CDSCO Manufacturing License for Video Capsule Endoscopy System Capsule

  1. Gather mandatory documents which include, but not limited to, Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Apply through the CDSCO’s online portal.
  3. Await CDSCO's evaluation and inspection of your manufacturing site.
  4. On approval, pay the relevant license fee.

If you encounter any difficulties, consider seeking assistance from a consultancy or agency familiar with the process.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Video Capsule Endoscopy System Capsule as per Medical Device Rules, 2017?

A1: The risk class of Video Capsule Endoscopy System Capsule is Class B.

Q2: What license is needed to manufacture Video Capsule Endoscopy System Capsule?

A2: To manufacture Video Capsule Endoscopy System Capsule, a MD5 license is required.

Q3: What is the fee for MD5 license for Video Capsule Endoscopy System Capsule?

A3: The fee for a MD5 license is Rs.5,000 and an additional Rs.500 per product.

Q4: Who will issue the manufacturing license for Video Capsule Endoscopy System Capsule?

A4: For Class B devices like the Video Capsule Endoscopy System Capsule, the license will be issued by the state FDA.

Q5: Is repackaging of Video Capsule Endoscopy System Capsule considered manufacturing?

A5: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Video Capsule Endoscopy System Capsule is also considered manufacturing requiring a MD5 license.

Conclusion

The licensing process can be a complex task, requiring a good understanding of the regulatory landscape and necessary documentation. It's crucial to get this right to maintain the trust of patients and healthcare professionals.

We at Pharmadocx Consultants are available at your service to guide you through this process comfortably. Please feel free to reach out to us at "+91-7404557227" or "[email protected]" for any queries.

For more information related to MD5 license, you can also check out our comprehensive article here. We look forward to hearing from you soon!

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