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CDSCO Manufacturing License for Pneumatic chest percussor

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. It is committed to ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices for the benefit of the patient population. It is responsible for approving licenses for the manufacture, sale, and import of these products in India.

In the medical device industry, obtaining manufacturing licenses is of paramount importance. A manufacturing license not only ensures that the medical device is legally produced, but it also guarantees that the device adheres to industry standards and protocols.

Let us discuss Pneumatic chest percussor, a Class B medical device and its medical significance in treating patients with respiratory disease.

The CDSCO portal provides all the necessary guidance documents, rules and guidelines related to medical devices license applications, you may visit here for more details.

What is Pneumatic chest percussor?

A Pneumatic chest percussor is a hand-held medical device designed to provide external vibrations to a patient's chest wall. By creating these vibrations, the device loosens excessive airway secretions in patients with respiratory diseases, thereby promoting airway clearance and improving bronchial drainage. The device has thus found wide applications in treating patients in intensive care units, chronic obstructive pulmonary disease (COPD) wards, and physiotherapy departments.

The Role of CDSCO in Medical Device Regulation

Since its inception, the CDSCO has been instrumental in controlling the quality of pharmaceuticals and medical devices available in India. One of their many roles is overseeing the regulatory framework for medical devices.

Manufacturing licenses for medical devices in India are enforced according to risk classification. Under the Medical Device Rules, 2017, medical devices are categorized into Classes A, B, C, and D. With Class A having the lowest perceived risk and Class D the highest.

The Pneumatic chest percussor falls under the Class B category.

How to manufacture Pneumatic chest percussor

Manufacturing the Pneumatic chest percussor involves following meticulous production procedures to ensure the device is reliable and safe for use. Detailed manufacturing guidelines as per the CDSCO guidelines need to be followed.

Fees for manufacturing license for Pneumatic chest percussor

Given that the Pneumatic chest percussor is a Class B device, the required license is the MD5. The fees for the MD5 license are Rs. 5,000 for the initial license, with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Pneumatic chest percussor?

Medical Device manufacturing license is obligatory for quality and safety in medical device production. Without a manufacturing license, manufacturers may not comply with the regulatory standards, producing substandard or unsafe products, thereby putting consumers and patients at risk. Adherence to regulatory compliance (MD5 license in this case) is imperative in healthcare to safeguard the health and well being of patients.

Steps to Obtain a CDSCO Manufacturing License for Pneumatic chest percussor

Acquiring a CDSCO Manufacturing License involves thorough documentation and following a defined process:

  1. Mount the necessary documents - Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application and all necessary documents.
  3. Wait for authorities to inspect the manufacturing site.
  4. Receive the license after approval.

The procedure might seem challenging, but following the prescribed guidelines strictly would certainly make the process manageable. Read more about obtaining an MD5 license on our website.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Pneumatic chest percussor as per Medical Device Rules, 2017? \

A1. The Pneumatic chest percussor is categorized as a Class B medical device.

Q2. What license is needed to manufacture Pneumatic chest percussor?

A2. To manufacture a Pneumatic chest percussor, an MD5 license is required.

Q3. What are the fees for the MD5 license for Pneumatic chest percussor?

A3. The fees of MD5 license for manufacturing Pneumatic chest percussor are Rs. 5,000 for the license and an additional Rs. 500 per device.

Q4. Who will issue the manufacturing license for Pneumatic chest percussor?

A4. The state FDA will issue the license to manufacture Class B devices like the Pneumatic chest percussor.

Q5. Is repackaging of Pneumatic chest percussor considered manufacturing?

A5. Yes, as per the 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 Pneumatic chest percussor is also considered manufacturing requiring an MD5 license.

Conclusion

Manufacturing a medical device in India requires the right guidance and expertise. At Pharmadocx Consultants, we assist in the license acquisition process for medical devices. Visit our website for further guidance or reach out to us at "+91-7404557227" or "[email protected]". Together, we can ensure that your product meets the required standards and regulations, delivering the highest quality healthcare devices to patients.

Don't hesitate to get in touch for consultation or assistance, we are always here to help.

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