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CDSCO Manufacturing License for Dental anaesthesia syringe, reusable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) assumes an essential role as the cornerstone of healthcare and medical device industry by regulating the quality and availability of drugs and medical devices. As the central drug authority in India, CDSCO sets the norms and standards, and ensures that manufacturing companies adhere strictly to them, thereby maintaining the sanctity of the medical sector. The manufacturing and trade of medical devices are under the purview of CDSCO, making this organization an unwavering sentinel for public health in India.

Manufacturing licenses are statutory requirements that act as tokens of authorization, permitting manufacturing units to produce, distribute, and sell medical devices. These licenses underscore the imperative of quality maintenance in the production and usage of medical devices.

One such important medical device is the Dental anaesthesia syringe, which plays a significant role in dental procedures by administering anaesthetic drugs to patients before dental surgeries. For further details, please refer to the official CDSCO website - here

What is Dental Anaesthesia Syringe?

A Dental anaesthesia syringe is a reusable, hand-held dental instrument specifically designed for injecting an anaesthetic agent, intramuscularly or subcutaneously, from a prefilled, single-use cartridge via a sterile needle attached to it. Commonly used in dental procedures, it prepares the patient for the upcoming procedure by desensitizing pain.

The Role of CDSCO in Medical Device Regulation

Serving the healthcare industry for countless years, the Central Drugs Standard Control Organization (CDSCO) undertakes critical responsibilities including the regulation and oversight of medical devices within a comprehensive regulatory framework. It ensures efficacy, quality, and safety of several products such as drugs, cosmetics and medical devices, that contribute towards making healthcare accessible to the public.

How to Manufacture Dental Anaesthesia Syringe

The manufacturing process of the Dental anaesthesia syringe involves precise steps designed following the industry standards. It requires verified raw materials, detailed planning, stringent quality checks, and extensive evaluative measures to ensure the final product meets the mandated quality threshold.

Fees for Manufacturing License for Dental Anaesthesia Syringe

Being a Class B medical device, a Dental anaesthesia syringe requires an MD5 license. The fees for an MD5 license is Rs. 5,000, along with an additional cost of Rs. 500 per product.

Why is a Manufacturing License Necessary for Dental Anaesthesia Syringe?

A manufacturing license acts as an official permit, without which producing and selling medical devices such as Dental anaesthesia syringe is prohibited. This is mandatory to regulate production quality, ensure patient safety, maintain regulatory compliance in the healthcare sector, and protect consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Dental Anaesthesia Syringe

  1. Prepare all prerequisite documents including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application to the appropriate authority.
  3. Follow up and respond to any queries during the approval process.
  4. Overcome common challenges in the licensing process by seeking expert advice and appropriate remedies.

Frequently Asked Questions (FAQs)

Q. What is risk class of Dental Anaesthesia Syringe as per Medical Device Rules, 2017?

The Dental Anaesthesia Syringe falls under the risk Class B.

Q. What license in needed to manufacture Dental Anaesthesia Syringe?

The Dental Anaesthesia Syringe requires an MD5 license for manufacturing.

Q. What is fees for MD5 license for Dental Anaesthesia Syringe?

The fees for an MD5 license is Rs. 5,000, with a product-based cost of Rs. 500.

Q. Who will issue manufacturing license for Dental Anaesthesia Syringe?

For class B devices like Dental anaesthesia syringe, the state FDA will issue the license.

Q. Is repackaging of Dental Anaesthesia Syringe considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Similarly, medical devices like Dental Anaesthesia Syringe are also considered drugs. Hence, the repackaging of Dental Anaesthesia Syringe also requires an MD5 license.

Conclusion

Gearing up for obtaining a manufacturing license might seem overwhelming but with proper guidance and support, the process becomes much smoother. Established consultancy firms like Pharmadocx Consultants bring a wealth of knowledge in the licensing sphere and can assist manufacturers in navigating through the labyrinth of licensing procedures. For more information on acquiring a manufacturing license for Class B medical devices, you can refer to this article. For any further queries, you may call "+91-7404557227" or email "[email protected]". Committed to your service, we always strive for the best.

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