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CDSCO Manufacturing License for Fistula-repair biomatrix implant

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Introduction

The Central Drugs Standard Control Organization, or better known as CDSCO, is an integral component of Indias's healthcare system. They are the primary authority responsible for setting standards and controlling the quality of drugs, cosmetics, diagnostics, and devices within India. One important function of CDSCO is granting manufacturing licenses for medical devices, a necessary step for ensuring quality and safety in their production.

In this post, we will primarily focus on one specific medical device, the Fistula-repair biomatrix implant. This remarkable medical device plays a crucial role in the field of gastroenterology. It offers a non-surgical solution to heal fistulas, which can be a source of serious complications if left untreated.

For more in-depth knowledge about CDSCO and medical devices, you can visit their official portal here.

After the introduction, add this exact line -

What is Fistula-repair biomatrix implant?

The Fistula-repair biomatrix implant is a bioabsorbable, animal-derived substance that is sterile and intended to be used in repairing fistulas. It achieves this by being injected into the fistula tract, such as anal or rectal fistula, to close it by promoting the growth and neovascularization of host tissue.

This novel medical intervention finds its use in a variety of procedures, most notably in managing patients suffering from medical conditions like perianal fistula, where traditional surgical interventions may not always be the best approach.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a rich history of ensuring the safety and efficacy of drugs and medical devices in India. Their mission is to safeguard and protect the public health by assuring safety, efficacy, and quality of drugs, cosmetics, and medical devices.

The regulatory framework of CDSCO for medical devices is extensive and multifaceted, involving pre-market approval, post-market surveillance, quality compliance, and licensing for manufacture and import. The agency continuously strives to adopt global best practices and works towards the harmonization of regulatory standards.

How to manufacture Fistula-repair biomatrix implant

The manufacturing of a Fistula-repair biomatrix implant is a complex process that requires advanced biomedical engineering techniques. It involves the careful selection of bioabsorbable animal-derived substances, sterilization and packaging to ensure it remains sterile until use.

Fees for manufacturing license for Fistula-repair biomatrix implant

The Fistula-repair biomatrix implant is a Risk Class D device therefore the required license is an MD9. The cost for obtaining an MD9 license is Rs. 50,000 and additionally, Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Fistula-repair biomatrix implant?

Obtaining a manufacturing license is a mandatory requirement for all medical devices, including the Fistula-repair biomatrix implant. This is to ensure the maintenance of high standards in terms of quality and safety.

Regulatory compliance is critical in the healthcare sector because it ensures patients are protected from substandard products. It also helps to maintain a level playing field in the market, as all manufacturers must meet the same stringent safety and quality standards.

Steps to Obtain a CDSCO Manufacturing License for Fistula-repair biomatrix implant

The process of obtaining a CDSCO Manufacturing License involves several steps:

  1. Prepare all the necessary documentation, such as the Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the filled application form along with the necessary documents to the CDSCO.
  3. The CDSCO will review the application and may ask for additional information or clarifications.
  4. Once approved, the applicant will receive the license and can commence manufacturing operations.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Fistula-repair biomatrix implant as per the Medical Device Rules, 2017? The Fistula-repair biomatrix implant is classified as a Risk Class D device.

Q2. What license is needed to manufacture Fistula-repair biomatrix implant? To manufacture Fistula-repair biomatrix implant, an MD9 license is needed.

Q3. What is the fee for an MD9 license for Fistula-repair biomatrix implant? The fee for an MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Fistula-repair biomatrix implant? For a Risk Class D device like Fistula-repair biomatrix implant, the CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Fistula-repair biomatrix implant considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. This includes the Fistula-repair biomatrix implant, so a license for MD9 would be required.

For more detailed information about the MD9 license, you can visit this link.

Conclusion

Acquiring a CDSCO Manufacturing License is an exacting process and requires expert knowledge to navigate the application process efficiently. At Pharmadocx Consultants, we are always ready to offer our expertise and assistance in this process. Do not hesitate to reach out to us via call at +91-7404557227 or by sending an email to [email protected].

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