CDSCO Manufacturing License for Anaesthesia breathing circuit

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal regulatory body for pharmaceuticals and medical devices in India. It is part of the Ministry of Health & Family Welfare, Government of India, and ensures the safety, efficacy, and quality of drugs and medical devices. Among its important functions are grant of manufacturing licenses, regulation of import and export of drugs, oversight of clinical trials, laying down standards, and influence over State FDAs.

In the medical device industry, procuring the necessary manufacturing licenses is of pivotal importance. A proper license ensures the device's regulatory compliance, its safety and efficacy, and the device’s conformity to best practices in production.

Our focus today is on the Anaesthesia breathing circuit, an essential component of patient care during surgeries. The device plays a crucial role in ensuring safe and efficient delivery of anaesthetic gases to the patient during surgery. You can find more information on the CDSCO's portal here.

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

What is an Anaesthesia Breathing Circuit?

An Anaesthesia Breathing Circuit is a complex assembly of devices that directs medical gases from the fresh gas outlet of an anaesthesia workstation to the patient. Its purpose is to provide an accurate and continuous supply of medical gases mixed with anaesthetic vapours.

The breathing circuit is frequently used in surgeries or medical procedures that require general anaesthesia. It facilitates the delivery of oxygen and anaesthetic gases, and the removal of carbon dioxide.

The Role of CDSCO in Medical Device Regulation

The CDSCO is pivotal to the safe and effective regulation of medical devices in India. It sets the standards, grants licenses, and oversees the production of these devices. CDSCO's regulatory framework ensures quality control, facilitates innovation, and sets guidelines for device trials, thereby enabling the manufacturing and distribution of safe and effective medical devices.

How to Manufacture an Anaesthesia Breathing Circuit

The manufacturing process for an Anaesthesia Breathing Circuit is complex and specialized. It requires precise engineering and high-quality materials. Rigorous quality checks and adherence to the guidelines laid down by the CDSCO are critical as well.

Fees for Manufacturing License for Anaesthesia Breathing Circuit

As an Anaesthesia Breathing Circuit falls under Risk Class B, the applicable license is MD5. The license fee is Rs. 5,000, and an additional fee of Rs. 500 per product is also payable.

Why is a Manufacturing License Necessary for an Anaesthesia Breathing Circuit?

Obtaining a manufacturing license is mandatory for production. It assures adherence to quality control measures, ensuring safety and efficacy in medical device production. The license underlines the importance of regulatory compliance within the healthcare sector and protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Anaesthesia Breathing Circuit

1. Compile the prerequisite documents. They include the Device Master File, the Quality Management Certificate, Device Details, Site details, etc.
2. Submit the application
3. Complete the necessary procedures as detailed by the regulatory body
4. Obtain approval

Obtaining a license can be challenging, but with foresight and help from experts these can be easily navigated. For more detailed guidance, visit this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Anaesthesia Breathing Circuit as per Medical Device Rules, 2017?

• Anaesthesia Breathing Circuit falls under Risk Class B.

Q2. What license is needed to manufacture an Anaesthesia Breathing Circuit?

• The license needed to manufacture an Anaesthesia Breathing Circuit is MD5.

Q3. What is the fee for the MD5 license for Anaesthesia Breathing Circuit?

• The license fee for MD5 is Rs. 5,000 and an additional fee of Rs. 500 per product.

Q4. Who will issue a manufacturing license for Anaesthesia Breathing Circuit?

• For Class B devices such as the Anaesthesia Breathing Circuit, the state FDA will issue the license.

Q5. Is repackaging of Anaesthesia Breathing Circuit considered manufacturing?

• Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By extension, medical devices are also considered drugs. Therefore, repackaging of Anaesthesia Breathing Circuit would require a license under MD5.

Conclusion

Obtaining a license for manufacturing medical devices can seem daunting, but with expert guidance, it can be a seamless process. Feel free to reach out to our team of experienced consultants at Pharmadocx for personalized assistance regarding the licensing process. Visit our website or call us at +91-7404557227. You can also drop us an email at [email protected]. Let us help you navigate the complexities of medical device licensing.