- Published on
CDSCO Manufacturing License for Gastroscope, General & Plastic Surgery
- Authors
- Name
- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body regarding medicines, drugs, and medical devices. The CDSCO has key responsibilities such as approving and monitoring clinical trials, maintaining quality control, laying down standards, and enforcing regulatory measures.
Manufacturing licenses are integral to the medical device industry, regulating the production of various medical devices to ensure their safety, efficacy, and quality. An important medical device that serves crucial functions in the medical world is the Gastroscope, used in General and Plastic Surgery.
Further details about CDSCO and medical devices can be found on CDSCO's official portal here.
- What is Gastroscope?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Gastroscope
- Fees for manufacturing license for Gastroscope
- Why is a Manufacturing License Necessary for Gastroscope?
- Steps to Obtain a CDSCO Manufacturing License for Gastroscope
- Frequently Asked Questions (FAQs)
- Conclusion
What is Gastroscope?
The gastroscope is a medical device mainly used in the field of gastroenterology. This flexible tube comes with a light and a video camera attached to its end, permitting the physician to visualize the patient's upper gastrointestinal tract. The device also facilitates the clinician to take tissue samples during the procedure for further evaluation.
The Role of CDSCO in Medical Device Regulation
The CDSCO is a crucial cornerstone in the history of India's healthcare regulation. Besides ensuring the quality of medicines and drugs, CDSCO plays an important role in regulating medical devices, such as a gastroscope. A comprehensive regulatory framework maintains the quality and safety standards of medical tools produced.
How to manufacture Gastroscope
The manufacturing of a Gastroscope involves multiple intricate steps that require strict adherence to quality control measures. Given its function, the manufacture of Gastroscopes must comply with a set of stringent guidelines provided by CDSCO and the licensing authorities.
Fees for manufacturing license for Gastroscope
The Gastroscope falls under Class B of the risk spectrum, and hence requires an MD5 license for its production. The fees for obtaining an MD5 license is Rs. 5,000 and Rs. 500 per product.
Why is a Manufacturing License Necessary for Gastroscope?
Operating within regulations and obtaining a proper manufacturing license is mandatory for all medical device manufacturers. It helps maintain the product's quality and safeguards patients against substandard or unsafe products. Compliance with regulatory requirements demonstrates a commitment to patient safety and the delivery of quality healthcare services.
Steps to Obtain a CDSCO Manufacturing License for Gastroscope
Obtaining a manufacturing license involves several prerequisites and steps. These include the submission of necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc., followed by a series of procedural steps like form submission, documentation evaluation, and obtaining approval.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of Gastroscope as per Medical Device Rules, 2017?
The Gastroscope is classified under risk class B for its intended usage.
Q2. What license is needed to manufacture Gastroscope?
To manufacture a device such as Gastroscope, an MD5 license is required.
Q3. What is the fees for MD5 license for Gastroscope?
The fees for obtaining an MD5 license is Rs. 5,000 for license and Rs. 500 per product.
Q4. Who will issue manufacturing license for Gastroscope?
State FDA will issue the license for manufacturing Class B devices like the Gastroscope.
Q5. Is repackaging of Gastroscope considered manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is deemed manufacturing, and similarly, medical devices like the Gastroscope also require a license for repackaging, that is MD5.
Conclusion
Seeking guidance during the process of obtaining a manufacturing license is useful given the complexity and importance of the process. For consultation and assistance with licensing procedures, you can reach out to experts at 'Pharmadocx Consultants' via their website PharmaDocx, call at "+91-7404557227" or email at "[email protected]".
Here's a detailed guide to obtaining an MD5 license, a requirement for manufacturing Gastroscopes.
