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CDSCO Manufacturing License for External cardiac compressor

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Governed by the Ministry of Health & Family Welfare, CDSCO is responsible for approval of new drugs, conducting clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations. It also regulates the manufacturers, distributors and importers of drugs and medical devices to ensure the safety, efficacy, and quality of these products.

In the ever-evolving medical device industry, obtaining a manufacturing license is a vital step, ensuring that companies adhere to the set standards and regulations for their products. This license is a testament to the safety and efficacy of a device, protecting consumers and establishing trust within the industry.

Today, we delve into the domain of External Cardiac Compressors: their significance and the vital role they play within the healthcare industry. To learn more about these devices and their regulatory guidelines, visit the CDSCO's portal at CDSCO's portal.

What is an External Cardiac Compressor?

An external cardiac compressor is a lifesaving medical device designed to administer chest compressions during cardiac arrest. Typically, this device is electrically, pneumatically, or manually powered and compresses the chest at regular intervals to support blood flow. It plays a pivotal role during instances such as patient transport or when there's a shortage of EMS personnel to provide effective CPR.

The Role of CDSCO in Medical Device Regulation

Over the years, the Central Drugs Standard Control Organization (CDSCO) has evolved to develop a robust regulatory framework for medical devices. Tasked with the mission to protect public health by ensuring that only safe, effective, and high-quality devices are made accessible to the people, the CDSCO maintains an exhaustive control over the quality of imported drugs and coordinates the activities of state drug control organizations.

How to Manufacture an External Cardiac Compressor

Manufacturing an External Cardiac Compressor involves adherence to the guidelines and regulations laid down by CDSCO. These rules ensure the safety, efficacy, and quality of the device.

Fees for Manufacturing License for External Cardiac Compressor

Based on its classification as a Class C device, the required license for manufacturing an external cardiac compressor is MD9. The fee involved is Rs. 50,000 for the license and Rs. 1,000 per product. If you require further information about this, visit this link.

Why is a Manufacturing License Necessary for an External Cardiac Compressor?

A manufacturing license guarantees that the device is produced while adhering to essential quality and safety standards set by regulatory bodies. It underscores the importance of regulatory compliance in the healthcare sector–ensuring that all products meet requisite quality controls and adhere to rigorous safety checks. More importantly, it protects consumers and patients from substandard products that may pose a danger to their health.

Steps to Obtain a CDSCO Manufacturing License for an External Cardiac Compressor

Accomplishing these steps will set you on track:

  1. Prepare the necessary documents such as the Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application for the license to the CDSCO.
  3. Await the approval of the license application.
  4. Address any challenges that arise with expert consultation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of External Cardiac Compressor as per Medical Device Rules, 2017?

A1. External Cardiac Compressor is a Class C device.

Q2. What license is needed to manufacture External Cardiac Compressor?

A2. The MD9 license is required to manufacture an External Cardiac Compressor.

Q3. What is the fees for MD9 license for External Cardiac Compressor?

A3. The fee for the MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for External Cardiac Compressor?

A4. For Class C devices like External Cardiac Compressor, the CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of External Cardiac Compressor considered manufacturing?

A5. Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is also considered manufacturing. Consequently, it would require an MD9 license.

Conclusion

Obtaining a manufacturing license for medical devices such as External Cardiac Compressors can be a complex task filled with regulatory hurdles. But this process becomes smoother and more manageable with expert assistance. Pharmadocx Consultants is here to guide and assist you throughout your licensing journey. For further guidance or any queries related to the process, feel free to visit our website or contact us at "+91-7404557227" or drop us an email at "[email protected]".

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