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CDSCO Manufacturing License for Powered corneal trephine

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority responsible for drug and medical device regulation. As the central body, CDSCO oversees standards and quality of drugs, cosmetics and medical devices in the country. A crucial component of its governance is ensuring that all manufacturing and distribution practices align with national and international standards to ensure the safety, efficacy, and quality of products. A manufacturing license is a vital requirement for the production of medical devices in India, and obtaining one is a stringent, monitored process.

Moving onto the focus of our discussion today, a Medical Device named Powered Corneal Trephine. This device is extensively used in ophthalmic surgeries for the resection or removal of a ring-shaped piece of corneal tissue. The device's importance in corneal transplant surgeries and maintaining the overall health of the eye is significant.

For more details about CDSCO and its regulatory framework, visit the CDSCO's portal

What is Powered Corneal Trephine?

In the medical field, a Powered Corneal Trephine is a highly specialized medical equipment used in ophthalmic surgery. The device, equipped with a blade, serves the purpose of resecting or removing a ring-shaped piece of the cornea, often referred to as the corneal button. Primarily, this instrument comes into play during corneal transplant surgeries, for example, where a healthy corneal graft is procured from a cadaver, the patient's diseased cornea is resected and removed to facilitate the transplantation of the graft.

The Role of CDSCO in Medical Device Regulation

Since its foundation, CDSCO has been tasked with the responsibility of ensuring public health safety through the regulation and oversight of medical devices. The organization has developed a robust regulatory framework to deal with the risk associated with medical devices' production and distribution.

How to manufacture Powered Corneal Trephine

To manufacture the Powered Corneal Trephine, one must first ensure that the necessary manufacturing license is in place. In this case, as the Powered Corneal Trephine falls under the Risk Class B category, the required license is MD5.

Fees for manufacturing license for Powered Corneal Trephine

The fee for obtaining an MD5 license is Rs. 5,000, along with Rs. 500 per product. This link provides more details on the MD5 License.

Why is a Manufacturing License Necessary for Powered Corneal Trephine?

A manufacturing license for medical devices like the Powered Corneal Trephine is not just mandatory but essentially safeguards the healthcare sector. It ensures that every medical device produced conforms to the standards of quality and safety established by the regulatory authorities. By ensuring regulatory compliance, a manufacturing license also protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Powered Corneal Trephine

Acquiring a CDSCO manufacturing license requires fulfilling prerequisites including, Device Master File, Quality Management Certificate, Device Details, Site details, and more. The application process entails submission and approval and can experience challenges which can be addressed with careful planning and consultation.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Powered Corneal Trephine as per Medical Device Rules, 2017?
The risk class of Powered Corneal Trephine as per Medical Device Rules, 2017, is Class B.

Q2. What license in needed to manufacture Powered Corneal Trephine?
The license needed to manufacture Powered Corneal Trephine is MD5.

Q3. What is fees for MD5 license for Powered Corneal Trephine? The fee for MD5 license for a Powered Corneal Trephine is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Powered Corneal Trephine?
The state FDA will issue the manufacturing license for the Powered Corneal Trephine.

Q5. Is repackaging of Powered Corneal Trephine 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. Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of the Powered Corneal Trephine is also considered manufacturing requiring a license on MD5.

Conclusion

We hope this article has provided you with comprehensive knowledge about the CDSCO manufacturing license for the Powered Corneal Trephine. However, navigating the license acquisition process can be challenging without professional help. We recommend reaching out to the experts at Pharmadocx Consultants. You can visit their website here, call them up at +91-7404557227 or send an email to [email protected] for consultation or assistance. They are experts in this field and can guide you smoothly through the process.

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