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CDSCO Manufacturing License for Anoscope, single-use

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Introduction

The Central Drugs Standard Control Organization (CDSCO) provides an overarching umbrella for the regulation of drugs and medical devices in India. Their goal is to achieve the highest standards of patient safety and public health through robust regulatory frameworks. CDSCO specifically takes charge of the permissions related to the import, clinical investigation, manufacturing, distribution, and sales of pharmaceuticals, drugs, and medical devices. A significant aspect of their regime is the licensing required for manufacturing medical devices.

In the medical device industry, authorization plays a pivotal role. It ensures patients' safety and upholds public health by ensuring the products' quality, safety standards, and efficacy. One such device that falls within the medical device ambit of the CDSCO is the Anoscope, single-use.

Anoscope is a critical medical instrument, primarily used for the visual examination and treatment of the anus and rectum. This post delves into the significance of the analeptic device, emphasizing the importance of manufacturing permits and the relevant regulations. Visit CDSCO's portal here.

What is Anoscope, single-use?

An Anoscope, single-use, is a sterile endoscope structure comprising a stiff portion designed for the visual inspection and treatment of the anus and rectum. These scopes serve primarily in the medical field of Gastroenterology.

The instrument assists doctors in performing procedures like anoscopy, rectal examination, hemorrhoid surgery, and diagnosing related rectal diseases. The distinct qualities of the Anoscope, combined with its functional purpose, make it a highly preferred device for gastroenterology.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization, or CDSCO, laid its foundation stone with an intent to regulate and control the manufacturing and distribution of drugs in India. Over the years, it has evolved to become a regulatory watchdog over medical devices.

CDSCO's primary responsibility consists of an extensive regulatory framework governing medical devices. This framework uses a risk-based approach to categorize devices into four classes - A, B, C, and D. The Anoscope falls under risk class B, implying that it has moderate-high risk potential.

How to manufacture Anoscope, single-use

To produce Anoscope, manufacturers must follow stringent guidelines, protocols, and standards, set by organizations like the CDSCO and sterilization standards like ISO 13137:2013.

The manufacturer should also get a license based on the device's risk class. Since Anoscope falls under class B, MD5 license is the prerequisite.

Fees for the manufacturing license for Anoscope, single-use

For devices under class B, an MD5 License is required. The fee for the MD5 license is Rs. 5,000, and an additional Rs. 500 is charged per product.

Why is a Manufacturing License Necessary for Anoscope, single-use?

Securing a manufacturing license for Anoscope or any other medical device is supreme. This authorization serves as an affirmation that the manufacturing plant follows high operational and safety standards while manufacturing the device.

Licensing provides a guarantee of quality and safety in device production and ensures regulatory compliance in the health sector. It also ensures that the consumers are protected from substandard or counterfeit products, thus promoting patient safety.

Steps to Obtain a CDSCO Manufacturing License for Anoscope, single-use

  1. Starting with the collation of Device Master File, Quality Management Certificate, Device Details, Site details, and more, the first step is to gather all the necessary documentation.

  2. Upon collection of all documents, the submission of the same on the CDSCO platform commences the application process.

  3. Post-submission, an exhaustive check and review of the application and documents are conducted, followed by an approval on positive evaluation.

  4. Although the process appears straightforward, facing hurdles is common, the key is to understand the challenge and find ways to overcome them.

Frequently Asked Questions (FAQs)

  1. Q: What is risk class of Anoscope, single-use as per Medical Device Rules, 2017?

    A: Anoscope, single-use falls under the risk class B as per Medical Device Rules, 2017.

  2. Q: What license is needed to manufacture Anoscope, single-use?

    A: To manufacture Anoscope, single-use, an MD5 license is required.

  3. Q: What is the fee for an MD5 license for Anoscope, single-use?

    A: The fee for an MD5 license is Rs. 5,000, and an additional Rs. 500 per product.

  4. Q: Who will issue the manufacturing license for Anoscope, single-use?

    A: The state FDA issues the license for class B devices such as Anoscope, single-use.

  5. Q: Is repackaging of Anoscope, single-use considered manufacturing?

    A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and, by further definitions, medical devices are also drugs. Hence, repackaging of Anoscope, single-use is also considered manufacturing requiring an MD5 license.

Conclusion

Gaining a comprehensive understanding of CDSCO's licensing procedures could be overwhelming. However, right guidance and assistance can make the journey smoother.

We, at Pharmadocx Consultants, are here to assist. Get in touch with us here, or call us at "+91-7404557227", or simply write to us at [email protected] for any queries or assistance.

Understanding the importance of licenses, if you need detailed knowledge about the MD5 license, go through our article Managing Regulatory Compliance – A Guide for Manufacturing Medical Devices using MD5 License in India.

Let us guide you through the intricacies of regulatory procedures and norms, ensuring successful, hassle-free licensing for your medical devices!

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