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

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a critical role within India's healthcare system. It is the country's main regulatory body overseeing drug safety and quality, including the ever-evolving field of medical devices. The manufacturing of medical devices is subject to strict licensing requirements under CDSCO's oversight, ensuring that products entering the market are safe, effective, and of high quality. In this regard, we delve into the significance of manufacturing licenses for a specific yet vital medical device, the Behind-the-Ear Air-Conduction Tinnitus Masker. CDSCO's portal serves as a valuable source of information for understanding the intricacies of obtaining a manufacturing license for such devices.

What is a Behind-the-Ear Air-Conduction Tinnitus Masker?

The Behind-the-Ear (BTE) Air-Conduction Tinnitus Masker is a specialised medical device designed to alleviate the ringing or buzzing sounds experienced by individuals suffering from tinnitus. This auditory condition can be a debilitating experience for many, making devices such as the BTE Tinnitus Masker a crucial tool in managing its symptoms. Functioning somewhat similar to a hearing aid, this device generates sound that masks the bothersome auditory perceptions of tinnitus.

Commonly, such a device is involved in therapeutic interventions aimed at retraining the brain to ignore the tinnitus, consequently increasing an individual’s comfort and quality of life.

The Role of CDSCO in Medical Device Regulation

The CDSCO has longstanding experience in the healthcare sector, with a mission pivoted towards ensuring the safety and effectiveness of medical products available within the Indian market. Its chief goal is the maintenance and implementation of standards pertinent to a broad spectrum of therapeutics, which include drugs, vaccines, and medical devices.

The regulatory framework of CDSCO for medical devices involves a rigorous evaluation process ensuring the safety, performance, and quality of such products, thereby fostering a trusted healthcare environment.

How to manufacture Behind-the-Ear Air-Conduction Tinnitus Masker

The manufacturing process necessitates strict conformity with the regulatory guidelines specified by CDSCO. Adherence to these guidelines is imperative to ensure the production of high-quality, safe, and effective devices.

Fees for manufacturing license for Behind-the-Ear Air-Conduction Tinnitus Masker

Since the Behind-the-Ear Air-Conduction Tinnitus Masker is categorized under Class B risk, the license required for manufacturing would be MD5. The fee for obtaining the MD5 license is Rs. 5,000, plus an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Behind-the-Ear Air-Conduction Tinnitus Masker?

Acquiring a manufacturing license from CDSCO is mandatory and serves to assure quality in the production of medical devices. It protects consumers and patients from substandard products by enforcing compliance with rigorous manufacturing standards. Within the healthcare sector, regulatory compliance bears paramount significance, since it directly impacts the safety and wellbeing of patients.

Steps to Obtain a CDSCO Manufacturing License for Behind-the-Ear Air-Conduction Tinnitus Masker

  1. Collate the required documents, such as the Device Master File, Quality Management Certificate, Device Details, and Site details, among others.
  2. File an application to CDSCO.
  3. Await approval from the regulatory body.
  4. Address any challenges or missing requirements noted by the reviewer and respond accordingly.

For more detailed information, please refer to this article.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Behind-the-Ear Air-Conduction Tinnitus Masker as per Medical Device Rules, 2017? The Behind-the-Ear Air-Conduction Tinnitus Masker falls under Class B of risk classification.

  2. What license is needed to manufacture a Behind-the-Ear Air-Conduction Tinnitus Masker? To manufacture this device, an MD5 license is required.

  3. What is the fee for an MD5 license for a Behind-the-Ear Air-Conduction Tinnitus Masker? The fee for the MD5 license is Rs. 5,000 for the license and an additional Rs. 500 per product.

  4. Who will issue the manufacturing license for a Behind-the-Ear Air-Conduction Tinnitus Masker? As a Class B device, the state FDA will issue the manufacturing license for the Behind-the-Ear Air-Conduction Tinnitus Masker.

  5. Is the repackaging of a Behind-the-Ear Air-Conduction Tinnitus Masker considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Further, medical devices are also treated as drugs under the Act. Hence, the repackaging of a Behind-the-Ear Air-Conduction Tinnitus Masker is considered manufacturing, requiring an MD5 license.

Conclusion

Obtaining a CDSCO manufacturing license for medical devices is a complex process that requires expert guidance. Pharmadocx Consultants are always ready to provide consultation or assistance throughout the process. For inquiries or assistance, please reach out or call at "+91-7404557227" or email to "[email protected]".

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