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CDSCO Manufacturing License for Behind-the-ear bone- conduction tinnitus masker

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body for pharmaceuticals and medical devices. Its chief mandate is to regulate the manufacture, sale, and distribution of drugs, ensuring that safe, effective and high-quality healthcare products are available to the public. In the context of medical devices, one of the key roles of CDSCO involves the granting and monitoring of manufacturing licenses.

Bearing significant relevance in the medical landscape is the behind-the-ear bone-conduction tinnitus masker. Instructive of its name and its indomitable purpose, this innovative medical device plays a key role in providing relief from the incessant ringing in the ears known as tinnitus. Offering a realm of therapeutic possibilities, this instrument is steeped in substantial medical significance.

For more information, visit CDSCO's portal at https://cdscomdonline.gov.in/NewMedDev/Homepage

What is Behind-the-ear bone- conduction tinnitus masker?

Purposely designed as an audiological solution, the behind-the-ear bone-conduction tinnitus masker is a device fabricated to mask the disturbing noise patterns characteristic of tinnitus. This device works by providing the ear with ultrasonic broadband noise and/or sweep-frequency stimuli, thus inundating the perceived tinnitus sound with ambient noise. Routinely used in the treatment of tinnitus, this device contributes significantly in improving the quality of life of tinnitus-afflicted individuals.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO, since its inception, has always been to safeguard and enhance the public's health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Particularly in the realm of medical devices, CDSCO's regulatory framework is anchored on the stringent assessment of clinical and non-clinical data, rigorous pre-market evaluation, and robust post-market surveillance.

How to manufacture Behind-the-ear bone-conduction tinnitus masker

The production of this medically significant device is regulated by stringent set of procedures laid out by CDSCO, to ensure their safety and efficacy.

Fees for manufacturing license for Behind-the-ear bone-conduction tinnitus masker

The manufacturing license for a Class C device, such as the behind-the-ear bone-conduction tinnitus masker requires the MD9 license. The fee for this license is Rs. 50,000 and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Behind-the-ear bone-conduction tinnitus masker?

Acquiring a manufacturing license is mandatory. It is a testament to the commitment of the manufacturer to delivering quality and safe medical devices. The stringent regulatory compliance stipulated by CDSCO serves to protect consumers and patients from substandard products, reinforcing the integrity of the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Behind-the-ear bone-conduction tinnitus masker

  1. Procuring necessary documentation including the Device Master File, Quality Management Certificate, Device Details and Site details.
  2. Submit application
  3. Evaluation of application by appropriate body
  4. Upon successful evaluation, approval and granting of license

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Behind-the-ear bone-conduction tinnitus masker as per the Medical Device Rules, 2017?

The Behind-the-ear bone-conduction tinnitus masker falls under Risk Class C.

Q2. What license is needed to manufacture Behind-the-ear bone-conduction tinnitus masker?

The MD9 license is required to manufacture the Behind-the-ear bone-conduction tinnitus masker.

Q3. What is the fee for MD9 license for Behind-the-ear bone-conduction tinnitus masker?

The fee for an MD9 license is INR 50,000, with an additional INR 1,000 per product.

Q4. Who will issue the manufacturing license for Behind-the-ear bone-conduction tinnitus masker?

As the Behind-the-ear bone-conduction tinnitus masker is a Class C medical device, the license will be issued by the CDSCO HQ in New Delhi.

Q5. Is repackaging of Behind-the-ear bone-conduction tinnitus masker considered manufacturing?

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. Hence, repackaging of Behind-the-ear bone-conduction tinnitus masker is also considered manufacturing requiring a license on MD9.

Conclusion

Obtaining a manufacturing license for a medical device, as essential as this, may seem complicated. But with the right guidance and expertise, navigating the convolutions of regulatory compliances can be made simpler. Pharmadocx Consultants offers exactly that, tailor-made solutions and assistance throughout the licensing process. You can connect with them at https://www.pharmadocx.com, call at +91-7404557227, or drop an email to [email protected].

For a detailed rundown of the licensing process for MD9, refer to this informative article - https://pharmadocx.com/cdsco-md9-manufacturing-license-consultant-for-medical-devices-in-india/

By being your partner throughout, we ensure you can focus on what is important, improving lives, one medical advancement at a time.

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