CDSCO Manufacturing License for Transilluminator for breast evaluation

Introduction

We embark on a journey into the world of medical manufacturing licenses, governed by the Central Drugs Standard Control Organization (CDSCO). Pivotal in its role in the healthcare sector, the CDSCO is India's national regulatory body for drugs and medical devices. Tasked with ensuring the safety, efficacy, and quality of medical and diagnostic devices, its significance can't be overstated.

One such critical medical device that we'll be exploring today is Transilluminator for breast evaluation. This device plays an essential role in the early detection and diagnosis of breast cancer, exerting a substantial impact on overall patient outcomes. More details about this device and the licensing requirements can be found on the CDSCO's portal here.

• What is Transilluminator for Breast Evaluation?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Transilluminator for Breast Evaluation
• Fees for Manufacturing License for Transilluminator
• Why is a Manufacturing License Necessary for a Transilluminator?
• Steps to Obtain a CDSCO Manufacturing License for Transilluminator
• Frequently Asked Questions (FAQs)
• Conclusion

What is Transilluminator for Breast Evaluation?

A transilluminator provides a non-invasive approach for examining changes in the breast tissue. By using low-intensity emissions of visible light and near-infrared radiation, it translucents tissue which assists in the diagnosis of cancer or other abnormalities. This device plays a pivotal role in the field of radiology, with its primary purpose being the early detection of breast cancer.

Moreover, it's utilized in numerous procedures, facilitating physicians to observe and document abnormal conditions, significantly enhancing the chances of successful treatment.

The Role of CDSCO in Medical Device Regulation

The CDSCO, as the apex regulatory body, has an extensive history of overseeing the manufacturing, sale, and import of medication and medical devices in India. Its mission to regulate and ensure the highest standards of quality and safety in healthcare products has resulted in a well-structured framework.

This regulatory framework helps manage all risk classes of medical devices (A to D), with Class D being the highest risk. Our focus, the Transilluminator device, falls under this Class D category.

How to Manufacture Transilluminator for Breast Evaluation

Getting a manufacturing license for this high-risk device is a stringent process administered by the CDSCO. Based on their guidelines, we require an MD9 license for manufacturing a Class D medical device like a Transilluminator.

Fees for Manufacturing License for Transilluminator

The cost for an MD9 license stands at Rs. 50,000, with an additional fee of Rs. 1,000 per product. You can get more information on the fees and the procedure to obtain the license here.

Why is a Manufacturing License Necessary for a Transilluminator?

Having a manufacturing license is not just a formality, it's an assurance of quality. It ensures that the medical devices produced comply with all the laid-down standards for safety and efficacy. This, in turn, safeguards consumer interests and protects patients from substandard products. Moreover, without a license, manufacturers can face legal repercussions.

Steps to Obtain a CDSCO Manufacturing License for Transilluminator

The process requires thorough documentation, including a Device Master File, Quality Management Certificate, device and site details, and more. The typical licensing procedure involves:

1. Submitting the completed application form.
2. Awaiting initial screening and scrutiny by authorities.
3. Submission of additional documents if requested.
4. Approval of license after satisfactory inspection and evaluation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Transilluminator for Breast Evaluation as per Medical Device Rules, 2017?

Transilluminator for Breast Evaluation falls under Class D, the highest risk category.

Q2. What license is needed to manufacture a Transilluminator?

Manufacturing a Transilluminator requires an MD9 license.

Q3. What are the fees for an MD9 license for a Transilluminator?

The fees for an MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for a Transilluminator?

For Class D devices like a Transilluminator, the license will be issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of a Transilluminator considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As the Transilluminator falls under the category of medical devices, which are also considered drugs, repackaging it would still require an MD9 license.

Conclusion

Navigating the complexities of medical device licensing can be a daunting experience. Our consultants at Pharmadocx are ready to assist in providing comprehensive guidance through the licensing process.

Reach out for consultation or assistance regarding the licensing process by calling "+91-7404557227" or sending an email to "[email protected]".

Remember, preparation and knowledge are key. With expert guidance, you can successfully navigate the dynamic landscape of medical device licensing.