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CDSCO Manufacturing License for Dental suction system pump

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Introduction

The Central Drugs Standard Control Organization, known as CDSCO, is the central regulatory authority for Indian pharmaceuticals and medical devices. Its backbone role consists of the approval of newly developed drugs and medical devices, clinical trials, laying down standards, and the enforcement of quality control.

In the burgeoning medical device industry, manufacturing licenses play a crucial role in regulating the production of equipment that is pivotal for medical procedures alongside ensuring compliance with safety and quality standards. A crucial cog in this mechanism is the dental suction system pump.

This blog introduces you to the CDSCO manufacturing licensing process for the dental suction system pump. To gain a deeper understanding of the significance of the device and the regulatory framework, one can refer to CDSCO's portal at CDSCO Portal.

What is a Dental Suction System Pump?

A dental suction system pump is an essential medical device designed to remove saliva, blood, and other debris from the patient's mouth during dental procedures. This equipment enhances safety and the efficiency of dental procedures, ensuring patient comfort and aiding in swift recovery.

Electrically powered, this medical device is generally used as the suction source of a dental suction system, dental treatment unit, etc. The effectiveness and the functionality of the dental suction system pump underscore the importance of stringent regulatory frameworks for its manufacturing.

The Role of CDSCO in Medical Device Regulation

A pivotal role is played by CDSCO in India's healthcare landscape, with its history rooted in the mission to safeguard and promote public health. It is the key agency responsible for licensing, monitoring, and control of medical devices in the nation.

CDSCO’s regulatory framework for medical devices entails defining the guidelines and norms for manufacturing, conducting clinical trials, the approval process, and post-market surveillance. With a commitment to ensure safety, quality, and efficiency, the regulations maintain the highest level of patient protection in consuming these medical devices.

How to manufacture a Dental Suction System Pump

The manufacturing of the dental suction system pump, categorized as a Class B device, requires an MD5 license. Given the importance of ensuring patient safety and reliability, the process is encompassed by strict regulations. This requires adherence to specific guidelines and standards at each step, maintaining the utmost quality and efficiency.

Fees for manufacturing license for a Dental Suction System Pump

As per CDSCO's regulation, acquiring an MD5 license for manufacturing a Class B device like a dental suction system pump involves fees of Rs. 5,000 for license and Rs. 500 per product. The fees are a part of regulatory compliance to ensure the highest level of patient safety in using these devices.

Why is a Manufacturing License Necessary for a Dental Suction System Pump?

Securing a manufacturing license is mandatory to manufacture medical devices including a dental suction system pump. This licencing ensures quality and safety in medical device production and attests that the product adheres to regulatory compliance in the healthcare sector. It shields consumers and patients from substandard products, ensuring the highest level of protection.

Steps to Obtain a CDSCO Manufacturing License for a Dental Suction System Pump

The manufacturing license acquisition process requires documents like Device Master File, Quality Management Certificate, Device Details, Site details, among others. The application process can be summarized in the following steps:

  1. Submission of the required documents along with application forms to CDSCO.
  2. The officer reviews the submitted documents and validates them.
  3. Site verification and inspections are carried out as per regulatory norms.
  4. Upon successful completion of all steps, the license is granted.

For a more detailed insight into the licensing process for Class B medical devices, you can refer to this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Dental Suction System Pump as per Medical Device Rules, 2017? - The Dental Suction System Pump falls into Class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture a Dental Suction System Pump? - An MD5 license is required to manufacture a Dental Suction System Pump.

Q3. What is the fee for an MD5 license for a Dental Suction System Pump? - The fee for an MD5 license to manufacture a Dental Suction System Pump is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Dental Suction System Pump? - For Class B devices like Dental Suction System Pump, the state FDA will issue the license.

Q5. Is repackaging of the Dental Suction System Pump considered manufacturing? - Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are also classified as drugs, repackaging a Dental Suction System Pump would also be considered manufacturing, requiring an MD5 license.

Conclusion

The adherence to CDSCO guidelines for obtaining a manufacturing license emphasizes the significance of ensuring quality and safety in the Healthcare sector. We encourage readers interested in learning more about the licensure procedures for the Dental Suction System Pump or require assistance in navigating the application processes to reach out to us at Pharmadocx Consultants. Please visit our website, call us on +91-7404557227, or write to us at [email protected] for more information.

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