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CDSCO Manufacturing License for Stoma support implant

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body that oversees the standards and quality assurance for drugs, cosmetics, and medical devices. The CDSCO ensures that these items are safe, effective, and adhere to required quality standards. This organization plays an essential role in safeguarding public health in India by enforcing strict guidelines and regulations for the manufacture, sale, and distribution of these products.

One crucial function of the CDSCO is granting manufacturing licenses for medical devices. A manufacturing license is a certification that the manufacturer has fulfilled all regulatory requirements and can legally produce the product. This is incredibly important in the medical device industry to ensure quality, safety, and efficacy.

In this article, we will delve into the specifics of the CDSCO manufacturing license for Stoma support implants, an important medical device in gastroenterology. These implants significantly reduce the risk of parastomal hernias by providing much-needed support to the abdominal wall surrounding the stoma. For more information on the CDSCO and its guidelines, you can visit their official site here.

What is a Stoma support implant?

A Stoma support implant is a sterile, non-bioabsorbable device specifically designed to be implanted into the abdominal wall during a gastro-urological ostomy procedure. The primary purpose of this implant is to reduce the risk of parastomal hernias by supporting the abdominal wall surrounding the stoma. Parastomal hernias are a common complication following ostomy surgery and can lead to discomfort and potential health risks.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health & Family Welfare, plays a pivotal role in the regulation of medical devices in India. It was formed with the mission to ensure the quality, safety, and efficacy of drugs and medical devices in the country. This is achieved by implementing a robust regulatory framework that includes high standards for licensing, monitoring, and enforcement of these products.

How to manufacture a Stoma support implant

The manufacturing of a Stoma support implant involves multiple stages, including design and development, material selection, manufacturing process, sterilization, and quality control. Each stage must adhere to stringent regulations to ensure the final product is high-quality, safe and effective.

Fees for manufacturing license for a Stoma support implant

As a Class C device, the manufacturing license required for a Stoma support implant is MD9. The cost associated with an MD9 license includes Rs. 50,000 for the license and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Stoma support implant?

A manufacturing license is mandatory for producing any medical device in India, including Stoma support implants. This license signifies that the manufacturer has adhered to the regulatory standards set by CDSCO, ensuring a quality and safe product for consumers.

In the healthcare sector, regulatory compliance is not just a legal requirement, it’s a sign of credibility. It signifies that the manufacturer understands and upholds the importance of product safety, efficacy, and quality in patient care. Additionally, it protects patients from substandard or unsafe products.

Steps to Obtain a CDSCO Manufacturing License for a Stoma support implant

Before applying for a manufacturing license, there are certain pre-requisites that need to be met. These include necessary documentation such as Device Master File, Quality Management Certificate, Device Details, Site details, and more. The application process from submission to approval involves several steps and can encounter common challenges. Having a detailed understanding of the process can aid in overcoming these obstacles.

Frequently Asked Questions (FAQs)

Q: What is the risk class of a Stoma support implant as per Medical Device Rules, 2017?

A: The Stoma support implant is classified as a Class C medical device.

Q: What license is needed to manufacture a Stoma support implant?

A: To manufacture a Stoma support implant, an MD9 license is needed.

Q: What is the fees for an MD9 license for a Stoma support implant?

A: The cost for an MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q: Who will issue the manufacturing license for a Stoma support implant?

A: For Class C devices like the Stoma support implant, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q: Is repackaging of a Stoma support implant considered manufacturing?

A: 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. Therefore, repackaging of a Stoma support implant is also considered manufacturing requiring an MD9 license.

Conclusion

Procuring a CDSCO manufacturing license for medical devices is a complex process that requires precise attention and understanding. If you need any assistance or consultation regarding the licensing process for medical devices, be it a Stoma support implant or another device, you can reach out to Pharmadocx Consultants. Feel free to call on +91-7404557227 or email [email protected] for further inquiries or assistance.

For more specific details on obtaining an MD9 license, you can read the article here. It is important to note that the obtaining of a manufacturing license is not just a regulatory requirement but a step towards protecting patients and ensuring high-quality healthcare in India.

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