CDSCO Manufacturing License for General electrosurgical unit

Introduction

The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India, is the central regulatory authority for the trade and distribution of pharmaceuticals and medical devices within India. It's principal responsibility is to ensure the safety, efficiency, and quality of drugs and medical devices being manufactured and marketed within India.

Manufacturing licenses play a crucial role in the medical devices industry. It is legal proof that the manufacturer adheres to established government regulations and ensures quality, safety, and efficacy of their product. Therefore, licenses are the backbone of the medical devices industry, encouraging competitive growth while assuring patient safety.

In this blog, we will intimate you about the General Electrosurgical Unit, a Class C risk device and the processes involved for manufacturing licensing from CDSCO.

You can avail more of this information on the CDSCO's official portal.

• What is a General Electrosurgical Unit?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture a General Electrosurgical Unit
• Fees for Manufacturing License for a General Electrosurgical Unit
• Why is a Manufacturing License Necessary for a General Electrosurgical Unit?
• Steps to Obtain a CDSCO Manufacturing License for a General Electrosurgical Unit
• Frequently Asked Questions (FAQs)
• Conclusion

What is a General Electrosurgical Unit?

A General Electrosurgical Unit is a medical device accompanied by accessories that cut/ coagulates tissues with high-frequency current or with the electricity/heat of their heating element. The main purpose of this device is to assist physicians to ensure that incisions or coagulations are made as intended, macroscopically or microscopically. These units play a primary role in dermatological and plastic surgery procedures where precision is key.

The Role of CDSCO in Medical Device Regulation

CDSCO holds significant jurisdiction and influence in the regulation of medical devices within India. Since its inception, the organization, through its regulations and various licenses, aims to establish India as a leader in the global medical devices market.

CDSCO's regulatory framework includes categorizing medical devices into four risk classes - A, B, C, and D, with A being the lowest and D being the highest. These classes guide the licensing and manufacturing regulations, ensuring a safer environment for both manufacturers and consumers.

How to Manufacture a General Electrosurgical Unit

To manufacture a general electrosurgical unit, which falls under risk class C, a manufacturer needs to follow CDSCO's stipulated guidelines. The manufacturer will also have to obtain the MD9 license, which applies to risk classes C and D.

Fees for Manufacturing License for a General Electrosurgical Unit

The fees for an MD9 license are Rs. 50,000 for the license itself and an additional Rs. 1,000 per product. Fees are subject to change as per Government norms.

Why is a Manufacturing License Necessary for a General Electrosurgical Unit?

• It is a mandatory requirement by law.
• It guarantees quality and safety in the production of medical devices.
• It highlights the importance of regulatory compliance in the healthcare sector.
• It assures the consumers and patients about the efficacy of the product.

Steps to Obtain a CDSCO Manufacturing License for a General Electrosurgical Unit

The process involves the submission of Device Master File, Quality Management Certificate, Device Details, Site details etc. The manufacturer submits the application and undergoes a review. If the application is accepted, the license is issued after the necessary payment.

• Device Master File
• Quality Management System Certificate
• Device Details
• Site Details

Read more about the process.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of a General Electrosurgical Unit as per Medical Device Rules, 2017? A: The risk class of a General Electrosurgical Unit is Class C.

2. Q: What license is needed to manufacture a General Electrosurgical Unit? A: An MD9 license is required to manufacture a General Electrosurgical Unit.

3. **Q: What is the fee for MD9 license for a General Electrosurgical Unit? ** A: The fee for an MD9 license for a General Electrosurgical Unit is Rs. 50,000 for the license and an additional Rs. 1,000 per product.

4. Q: Who will issue the manufacturing license for a General Electrosurgical Unit? A: The CDSCO HQ in New Delhi will issue the manufacturing license for the General Electrosurgical Unit.

5. Q: Is repackaging of a General Electrosurgical Unit considered as manufacturing? A: 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 a General Electrosurgical Unit is also considered manufacturing requiring a license on MD9.

Conclusion

Acquiring the right manufacturing license for medical devices can be a complex task. To assist you through the process, Pharmadocx Consultants offer professional and quality services. Our expert team is just a call away. Feel free to reach out at "+91-7404557227" or drop us an email at "[email protected]".

Heavy regulation in the medical device industry can be overwhelming, especially when it comes to licensing and production; however, these measures ensure the safety and efficacy of medical devices. Protecting patient health and safety is of paramount importance, and as such, the role of CDSCO and its regulatory measures are a necessary part of this ecosystem.