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CDSCO Manufacturing License for Robotic electrosurgical instrument, bipolar, single- use

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in the healthcare industry as the national regulatory body for Indian pharmaceuticals and medical devices. Entrusted with safeguarding and enhancing public health, CDSCO's primary functions include the approval of new drugs, conducting clinical trials, laying down standards for drugs, control over the quality of imported drugs, coordination of state drug control, and providing expert advice to the government on regulatory matters.

One of the critical aspects that CDSCO oversees is the licensing of manufacturing medical devices. These licenses are vital as they ensure that the products produced conform to the stringent quality and safety guidelines set forth by the government.

In this blog, we delve into the specifics of the Robotic Electrosurgical Instrument, a breakthrough medical device that plays an integral part in endoscopic surgeries, particularly in the domain of gastroenterology. Its ability to deliver precise and efficient electrosurgical currents makes it a revolutionary tool in the medical device industry. For more details, please visit CDSCO's portal here.

What is a Robotic Electrosurgical Instrument?

The Robotic Electrosurgical Instrument is a sterile medical device designed to connect directly to the manipulator arm of a robotic surgical system. It delivers electrosurgical current in a bipolar configuration, eliminating the need for a separate return electrode. This instrument is primarily utilized in endoscopic surgeries, such as laparoscopic and arthroscopic procedures, providing critical cutting, coagulation, and ablation capabilities, thereby contributing to the accuracy and safety of surgical procedures.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been committed to fostering public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices available in the Indian market. A significant part of this mission involves the regulation of medical devices. CDSCO executes this role by implementing a comprehensive regulatory framework, encompassing everything from the approval of new medical devices, conducting the necessary quality tests, to enforcing norms for manufacturers.

How to Manufacture a Robotic Electrosurgical Instrument

Production of the Robotic Electrosurgical Instrument involves rigorous protocols governed by the established CDSCO guidelines. Given this device falls under the Class C category, it necessitates a MD9 license for manufacturing.

Fees for Manufacturing License for Robotic Electrosurgical Instrument

The fees for obtaining a manufacturing license for the Robotic Electrosurgical Instrument, a Class C device, involves a license cost of Rs. 50,000 alongside an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Robotic Electrosurgical Instrument?

It is mandatory to acquire a manufacturing license before producing any medical device. Ensuring the quality and safety of the manufacturing process is imperative in the healthcare sector. It helps protect consumers and patients alike from substandard products while fostering transparency and accountability in the production process.

Steps to Obtain a CDSCO Manufacturing License for a Robotic Electrosurgical Instrument

  1. Collation of necessary documents, including Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submission of all documentation and application to the relevant authorities.
  3. Follow-up with the approval process.
  4. Address any challenges that may arise during the approval process.

Frequently Asked Questions (FAQs)

  1. What is the risk class of the Robotic Electrosurgical Instrument as per Medical Device Rules, 2017? Answer: The Robotic Electrosurgical Instrument falls under the Class C risk category.
  2. What license is needed to manufacture a Robotic Electrosurgical Instrument? Answer: To manufacture a Robotic Electrosurgical Instrument, an MD9 license is required.
  3. What is the fee for an MD9 license for a Robotic Electrosurgical Instrument? Answer: The license fee for an MD9 license for a Robotic Electrosurgical Instrument is Rs. 50,000. Additionally, there is a per product fee of Rs. 1,000.
  4. Who will issue the manufacturing license for a Robotic Electrosurgical Instrument? Answer: The manufacturing license for a Robotic Electrosurgical Instrument, a Class C device, will be issued by the CDSCO HQ in New Delhi.
  5. Is repackaging of a Robotic Electrosurgical Instrument considered manufacturing? Answer: Yes, in accordance with the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Given that medical devices also fall under the category of drugs, repackaging of a Robotic Electrosurgical Instrument also necessitates a manufacturing license, namely, MD9.

Conclusion

While the process may seem overwhelming at first, acquiring a license for a medical device such as the Robotic Electrosurgical Instrument is straightforward if properly guided. The team at Pharmadocx Consultants stands ready to help you navigate this process. You can reach out to us for any consultation or assistance regarding the licensing process at +91-7404557227 or [email protected].

For more information about MD9 license, please visit our article on this subject. Together, let's make healthcare better and safer.

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