Published on

CDSCO Manufacturing License for Neonatal chest percussor

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) serves as the apex regulator for pharmaceuticals and medical devices in India. It ensures the safety, efficacy, and quality of drugs and devices, regulates medical and diagnostic devices, and oversees e-pharmacies. From ensuring compliance to global standards to monitoring and inspecting the manufacturing and marketing processes across the country, CDSCO has become a beacon of quality control in the Indian medical landscape.

Manufacturing licenses play a pivotal role in the medical device industry. They serve as testimonials that the product has passed rigorous quality testing and adheres to international standards. One such device requiring a manufacturing license is the Neonatal Chest Percussor. Vital for stabilizing the health of neonates dealing with bronchial mucus, this device has significant medical importance.

For more detailed information about licensing and regulations, please visit the CDSCO's portal here.

What is Neonatal Chest Percussor?

A Neonatal chest percussor is a handheld medical device used by healthcare professionals to provide external vibrations to a neonate's chest wall. The vibrations help in loosening bronchial mucus and aid in its expectoration through suctioning. This device becomes critical when neonates are unable to perform the natural cough mechanism required to clear the lungs of secretion build-up.

It's common usage involves assisting in anesthesia procedures for newborns.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health and Family Welfare, is tasked with ensuring the safety, efficacy, and quality of medical devices in India. It was established with the objective of implementing and enforcing the Drugs and Cosmetics Act, which regulates the import, manufacture, distribution, and sale of drugs and medical devices.

Their regulatory framework for medical devices involves classifying them into four groups based on risk and determining license requirements accordingly.

How to Manufacture Neonatal Chest Percussor

The manufacturing process involves complying with regulations for Class B medical devices and acquiring an MD5 manufacturing license.

Fees for Manufacturing License for Neonatal Chest Percussor

The fee structure for an MD5 license involves an initial fee of Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Neonatal Chest Percussor?

Having a manufacturing license is mandatory as per CDSCO regulations. It ensures both the quality and safety of medical device production. In a healthcare context, regulatory compliance is of paramount importance. It protects consumers and patients from the risk of using substandard products and ensures they get the best possible healthcare.

Steps to Obtain a CDSCO Manufacturing License for Neonatal Chest Percussor

Obtaining the license requires the following steps:

  1. Gathering required documents like Device Master File, Quality Management Certificate, Device Details, Site Details, etc.
  2. Preparing and submitting the application
  3. Coordinating with the regulatory body during the review process
  4. Going through the approval process

For detailed information about obtaining the license, click here.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Neonatal Chest Percussor as per Medical Device Rules, 2017?

    The Neonatal Chest Percussor falls under Risk Class B.

  2. What license is needed to manufacture Neonatal Chest Percussor?

    An MD5 license is required to manufacture the Neonatal Chest Percussor.

  3. What is the fees for MD5 license for Neonatal Chest Percussor?

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

  4. Who will issue the manufacturing license for Neonatal Chest Percussor?

    For Class B devices like the Neonatal Chest Percussor, the state FDA will issue the license.

  5. Is repackaging of Neonatal Chest Percussor considered manufacturing?

    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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Neonatal Chest Percussor is also considered manufacturing requiring a license on MD5.

Conclusion

We would encourage anyone in need of consultation or assistance regarding the licensing process for the Neonatal Chest Percussor to reach out to Pharmadocx Consultants. Alternatively, you can talk to a representative at "+91-7404557227" or via email to "[email protected]." We assure you of our commitment to your needs.

cdsco import license in india banner
cdsco manufacturing license in india banner