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CDSCO Manufacturing License for Transcutaneous air conduction hearing aid system

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Introduction

Central Drugs Standard Control Organization (CDSCO) is a central governmental body acting as the national regulatory authority for Indian pharmaceuticals and medical devices. It plays a significant role in ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO is also responsible for issuing various licenses for the manufacturing, import, conduct of clinical trials, marketing, and sale of these medical supplies and equipment.

Manufacturing licenses hold significant value in the medical device industry. Not only are they a legal obligation, but displaying a license also conveys a sense of trust and assurance to consumers regarding the quality and safety of the device.

Today, we focus on the Transcutaneous air conduction hearing aid system, an innovative medical device revolutionizing auditory aid methods. It is crucial to understand the significance of this device and the licensing requirements before its manufacturing process. For more information related to medical device manufacturing licenses issued by CDSCO, you can visit their portal here.

What is Transcutaneous air conduction hearing aid system?

This medical device is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The system, precisely, is designed to provide hearing improvements for individuals struggling with hear loss or other auditory impairments. It operates via a transcutaneous method, meaning it communicates through the skin.

Commonly, the Transcutaneous air conduction hearing aid system is used by individuals with varying degrees of hearing loss. It’s versatile and non-invasive approach and modern design make it a popular choice among many users.

The Role of CDSCO in Medical Device Regulation

CDSCO has been fostering the health and safety of the nation through its effective and efficient regulation of drugs and medical devices. Ensuing the mission to safeguard and enhance public health, it ensures quality, safety, and performance of medical devices sold in Indian territory.

CDSCO’s regulatory framework for medical devices involves the evaluation and approval of medical devices based on their risk classification under the Medical Device Rules, 2017. It is crucial to align the manufacturing process in accordance with these regulations to ensure the deliverance of safe and quality medical devices.

How to manufacture Transcutaneous air conduction hearing aid system

The manufacturing of the Transcutaneous air conduction hearing aid system, like any other medical device, requires strict adherence to CDSCO guidelines. As a Class C device, it falls under high-risk devices, and specific protocols must be followed, which we will discuss in a later section.

Fees for manufacturing license for Transcutaneous air conduction hearing aid system

For the manufacture of a Class C device such as the Transcutaneous air conduction hearing aid system, the required license is MD9. The fees for MD9 license are Rs. 50,000 for the license and an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Transcutaneous air conduction hearing aid system?

Manufacturing licenses are not just simple legal necessities. They contribute significantly to ensuring quality and safety in medical device production. Regulatory compliance in the healthcare sector carves the path towards the manufacture of standard and efficient medical devices. Having manufacturing licenses also helps in winning the trust of customers and keeps them safe from substandard products.

Steps to Obtain a CDSCO MD9 Manufacturing License for Transcutaneous air conduction hearing aid system

Commencing with acquiring necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, the licensing procedure involves some primary steps:

  1. Submission of application
  2. Regulatory review
  3. Approval of the license
  4. Post-marketing surveillance

Overall, it's a linear process but could bear other challenges. For more detailed guidance, you can refer here.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Transcutaneous air conduction hearing aid system as per Medical Device Rules, 2017?

Class C

Q. What license is needed to manufacture Transcutaneous air conduction hearing aid system?

MD9

Q. What is the fee for MD9 license for Transcutaneous air conduction hearing aid system?

Rs. 50,000 for the license and Rs. 1,000 per product

Q. Who will issue manufacturing license for Transcutaneous air conduction hearing aid system?

CDSCO HQ in New Delhi

Q. Is repackaging of Transcutaneous air conduction hearing aid system 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 Transcutaneous air conduction hearing aid system is also considered manufacturing requiring a license on MD9.

Conclusion

The process of licensing might seem lengthy but with the right guidance, you can navigate through it effectively. If you still have further queries or need assistance with the licensing process, you can reach out to Pharmadocx Consultants or call on +91-7404557227 or even email them at [email protected].

Pharmadocx can assist in license procurement among its wide range of services, promising a hassle-free experience throughout your licensing journey. Don’t let paperwork stand in your way in delivering quality medical devices. Contact us today!

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