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CDSCO Manufacturing License for Battery-powered artificial larynx

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's central body for the regulation of drugs and medical devices, playing a fundamental role in maintaining the safety, efficacy, and quality standards of these essential products. It oversees the approval of new drugs and clinical trials, the import of drugs and pharmaceuticals, and the manufacture of medical devices. Among its most significant responsibilities is the issuance of manufacturing licenses for medical devices - a requirement enshrined in law to control the quality and safety of these products.

The Battery-Powered Artificial Larynx, the medical device in question, is one of the many devices regulated by CDSCO. Its role is crucial in the medical world, allowing patients without a larynx to communicate again. For more information about CDSCO and its services, you can visit their official portal here.

What is a Battery-Powered Artificial Larynx?

A Battery-Powered Artificial Larynx is a medical device, usually externally applied, solely intended to produce sound in the absence of a larynx. This device is critical for individuals who have undergone a laryngectomy, allowing them to communicate orally.

The use of a battery-powered artificial larynx often involves ENT (Ear, Nose, Throat) procedures concerning the vocal cords, larynx, or throat.

The Role of CDSCO in Medical Device Regulation

CDSCO has a decisive function in regulating medical devices within India's territory. Its core mission is to safeguard the public health by assuring the quality, safeness, and effectiveness of drugs and medical devices in the country.

CDSCO's regulatory framework for medical devices involves licensing, monitoring, and enforcement of regulations.

How to manufacture a Battery-Powered Artificial Larynx

Manufacturing a battery-powered artificial larynx requires conformation to various regulatory standards set by CDSCO and obtaining the appropriate license for manufacturing Class B medical devices - the MD5 license.

Fees for manufacturing license for a Battery-Powered Artificial Larynx

The MD5 license, specific to class B medical devices, has a cost of Rs. 5,000 for the license and an additional fee of Rs. 500 per product. For more information, you can visit this link.

Why is a Manufacturing License Necessary for a Battery-Powered Artificial Larynx?

Obtaining a manufacturing license is mandatory as per the regulations set by the CDSCO. It ensures quality and safety in the production of medical devices, prevents the spread of substandard products, and promotes regulatory compliance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for a Battery-Powered Artificial Larynx

  1. Gather necessary documents including a Device Master File, Quality Management Certificate, device details, and site details
  2. Submit your application to the appropriate regulatory authority
  3. Review feedback and make necessary revisions to your application.
  4. Wait for approval, and take steps as recommended by the authorities to rectify any issues pointed out during the review process

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Battery-Powered Artificial Larynx as per Medical Device Rules, 2017?

A. The risk class for a battery-powered artificial larynx as per Medical Device Rules, 2017, is Class B.

Q2. What license is needed to manufacture a Battery-Powered Artificial Larynx?

A. The MD5 license is required for the manufacture of a battery-powered artificial larynx.

Q3. What is the fee for the MD5 license for a Battery-Powered Artificial Larynx?

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

Q4. Who will issue the manufacturing license for a Battery-Powered Artificial Larynx?

A. For Class B devices like the battery-powered artificial larynx, the state FDA will issue the license.

Q5. Is repackaging of a Battery-Powered Artificial Larynx considered manufacturing?

A. Yes, repackaging is considered manufacturing under the Drugs and Cosmetics Act, and thus requires an MD5 license.

Conclusion

The regulatory landscape for medical devices can be complex and challenging. If you require consultation or assistance with the licensing process for a Battery-Powered Artificial Larynx or any other medical device, you are encouraged to reach out to Pharmadocx Consultants, call at +91-7404557227, or send an email to [email protected]. They can provide you with the expertise and guidance needed to successfully navigate the CDSCO's regulatory requirements and obtain a manufacturing license for your medical device.

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