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CDSCO Manufacturing License for Powered suction pump.

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Introduction

The Central Drugs Standard Control Organization (CDSCO ) is a crucial pillar of India's healthcare and pharmaceutical industry. It plays a vital role in safeguarding and promoting public health in the country by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices available to the public. Among the authoritative mandates of CDSCO is the issuance of licenses for the manufacturing of medical devices, a key component in safeguarding patient welfare.

The manufacturing licenses issued by CDSCO play a significant role in the medical device industry as they regulate and monitor the quality and standard of these devices. They establish a framework within which medical devices must be produced to ensure that they adhere to the safety measures and best practices for the benefit of the end-users.

In this article, our focus will be on understanding the significance, manufacturing process, licensing requirements, and the role of CDSCO in the regulation of a 'Powered suction pump' - a Class B category medical device widely used in dermatological and plastic surgeries. To get more information on this and other regulations, you can visit the CDSCO's official portal here.

What is a Powered Suction Pump?

A Powered Suction Pump is a device primarily used for removing unwanted fluids or infectious materials from patients' wounds or their respiratory support systems. This equipment can be powered either by AC power or compressed air, making it suitable for a variety of medical environments. Possessing compatibility for both operating room procedures and bedside use, these devices often include a microbial filter to ensure hygiene and prevention of contamination during use.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health and Family Welfare, holds the primary responsibility for ensuring the safety and efficacy of medical devices in India. It operates with the mission of advancing public health by enabling access to high-quality medical devices. To this end, CDSCO ensures the fastidious implementation of a regulatory framework for medical devices, providing a robust guideline for manufacturers to follow.

How to Manufacture a Powered Suction Pump

Manufacturing a Powered Suction Pump requires adherence to highest standards of quality as they play a critical role in various medical procedures. A detailed manufacturing process would require a separate discussion, which may be beyond the scope of this article.

Fees for Manufacturing License for Powered Suction Pump

Since a Powered Suction Pump is classified under Class B, the required license for manufacturing is MD5. The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product. For more information on the MD5 license, you can read this article.

Why is a Manufacturing License Necessary for a Powered Suction Pump?

Obtaining a manufacturing license for a Powered Suction Pump is mandatory ensuring the quality and safety of their production process. An MD5 license indicates adherence to the regulatory compliance within the healthcare sector, protecting patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Powered Suction Pump

Acquiring a CDSCO manufacturing license involves the following steps:

  1. Submission of required documents such as Device Master File, Quality Management Certificate, Device Details, Site Details etc.
  2. Completion and submission of the application form.
  3. Approval of the application form by the right authority.
  4. Obtaining the license after receiving positive feedback.

Navigating this process can be challenging, and you may face some hurdles.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Powered Suction Pump as per Medical Device Rules, 2017?

  • Answer: The Powered Suction Pump is classified as Class B.

Q2. What license is needed to manufacture a Powered Suction Pump?

  • Answer: An MD5 license is required for manufacturing a Powered Suction Pump.

Q3. What are the fees for an MD5 license for a Powered Suction Pump?

  • Answer: The fees are Rs. 5000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Powered Suction Pump?

  • Answer: State FDA will issue the license for a Powered Suction Pump, as it is a Class B device.

Q5. Is repackaging of a Powered Suction Pump considered manufacturing?

  • Answer: 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. So, repackaging of the Powered Suction Pump is also considered manufacturing requiring an MD5 license.

Conclusion

The manufacturing process for medical devices like Powered Suction Pumps is complex and requires compliance with numerous regulations and guidelines issued by the CDSCO. If you need assistance in navigating the licensing process or have any queries related to it, feel free to reach out to Pharmadocx Consultants here or call at +91-7404557227 or email to contact@pharmadocx.com. The expert team is always ready to guide you through each step and ensure a smooth and efficient process.

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