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CDSCO Manufacturing License for Gastrointestinal anastomosis coupler, bioabsorbable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's principle regulatory body that oversees the quality of drugs and medical devices. The prime function of CDSCO is to safeguard and promote public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. It is equipped with an unerring set of regulations, standards, and guidelines to ensure the optimum level of compliances and governance matched to the international standards.

With the advent of superior technologies, the medical device industry has been at the forefront of modern healthcare. Manufacturing licenses provide a governing regulatory checklist for manufacturing standards, ensuring the safe and efficient production of medical devices. Regulated manufacturing ensures that every device in the healthcare industry is reliable and of the highest quality.

Today, we explore a critical medical device - the Gastrointestinal Anastomosis Coupler, Bioabsorbable, highlighting its medical significance and the requisite CDSCO manufacturing license. Please refer to CDSCO's portal for more information.

What is a Gastrointestinal Anastomosis Coupler, Bioabsorbable?

The Gastrointestinal Anastomosis Coupler, also known as Bioabsorbable, is a revolutionary device that is implanted and used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. Owing to its design and functionality, it ensures a streamlined surgical procedure and improved patient recovery time.

This medical device finds widespread use in surgical procedures involving gastrointestinal structures, offering a safe, secure and minimally invasive alternative to traditional surgical methods.

The Role of CDSCO in Medical Device Regulation

The regulatory landscape for medical devices in India is anchored by CDSCO. Over the years, its mission has been to preserve and promote public health in India through the regulation of quality and efficacy in the healthcare industry.

CDSCO’s regulatory framework is comprehensive, comprising a clear-cut hierarchy of risk classes - A, B, C, D - with Class A devices posing the lowest risk to patients and class D devices representing the highest risk category.

How to Manufacture Gastrointestinal Anastomosis Coupler, Bioabsorbable

The manufacturing of the Gastrointestinal Anastomosis Coupler, a Class D device, is contingent on the acquisition of an MD9 manufacturing license. The licensing process is streamlined, having clearly outlined steps to ensure that all procedural, quality and safety guidelines are scrupulously followed.

Fees for Manufacturing License for Gastrointestinal Anastomosis Coupler, Bioabsorbable

The fee for obtaining an MD9 license to manufacture a Class D device like the Gastrointestinal Anastomosis Coupler is Rs. 50,000 for the license and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Gastrointestinal Anastomosis Coupler, Bioabsorbable?

Procuring a manufacturing license for a medical device like Gastrointestinal Anastomosis Coupler is mandatory by law. It ensures quality and safety in medical device production, safeguarding patient health. Furthermore, regulatory compliance showcases a healthcare company’s commitment to enforcing safety protocols and manufacturing high-standard devices. Finally, it protects consumers and patients by auditing and qualifying manufacturers and their devices, eliminating substandard products from the market.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal Anastomosis Coupler, Bioabsorbable

The licensing process requires a set of preliminary documentation such as Device Master File, Quality Management Certificate, Device Details, Site details, among others.

The application includes several stages like submission of the necessary documents, assessment and review, followed by approval.

Overcoming the common challenges need meticulous planning and adherence to the framework prescribed by CDSCO.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gastrointestinal Anastomosis Coupler, Bioabsorbable as per Medical Device Rules, 2017?

The Gastrointestinal Anastomosis Coupler, Bioabsorbable is classified under risk Class D as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Gastrointestinal Anastomosis Coupler, Bioabsorbable?

An MD9 license is requisite to manufacture the Gastrointestinal Anastomosis Coupler, Bioabsorbable.

Q3. What is the fee for an MD9 license for the Gastrointestinal Anastomosis Coupler, Bioabsorbable?

The fee for an MD9 license is Rs. 50,000 for the license with an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Gastrointestinal Anastomosis Coupler, Bioabsorbable?

The manufacturing license for Class D medical devices like the Gastrointestinal Anastomosis Coupler is issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of the Gastrointestinal Anastomosis Coupler, Bioabsorbable considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of a medical device is considered manufacturing, requiring an MD9 license in this case.

Conclusion

Securing a CDSCO manufacturing license may feel like an overwhelming process, but it can be significantly simplified with the assistance of seasoned professionals. For further details, please reach out to Pharmadocx Consultants through a call at "+91-7404557227", or write an email to "[email protected]".

For information regarding the MD9 license, check our article: CDSCO MD9 Manufacturing License

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