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CDSCO Manufacturing License for Dental anaesthesia syringe cartridge

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Introduction

The Central Drugs Standard Control Organization, commonly referred to as CDSCO, is an invaluable asset in the healthcare sector in India. This paramount organization shoulders the responsibility of ensuring the safety, efficacy, and quality of drugs, cosmetics, medical devices, and diagnostics sold in India. A significant part of CDSCO's function is regulating the manufacturing of medical devices, a crucial aspect of maintaining high standards of healthcare products in the country.

One such crucial medical device is the Dental Anaesthesia Syringe Cartridge. Used widely in dental practices, it plays a vital role in dental patient care. Access CDSCO's portal here for additional resources and information.

What is a Dental Anaesthesia Syringe Cartridge?

A Dental Anaesthesia Syringe Cartridge is an essential aspect in the process of dental anesthesia. Consisting of a prefilled single dose of anaesthetic medication, the Dental Anaesthesia Syringe Cartridge is inserted into a dental anaesthesia syringe when medical practitioners need to numb oral tissues in patients during a dental procedure. It's a common tool in almost every dental clinic and a vital component in ensuring that patients receive optimal care with minimal discomfort.

The Role of CDSCO in Medical Device Regulation

The CDSCO has the critical mission of ensuring that every drug, cosmetic, diagnostic and medical device available in the Indian markets meets the highest safety and quality standards. Their regulatory framework provides a well-organized method for implementing controls and measures, thereby ensuring every device's efficiency and safety, including the Dental Anaesthesia Syringe Cartridge.

How to Manufacture Dental Anaesthesia Syringe Cartridge

Creating a quality Dental Anaesthesia Syringe Cartridge involves precision, expertise and stringent quality controls. The manufacturing process requires adherence to regulatory guidelines set by the CDSCO to ensure its safety and effectiveness in providing local anesthesia during dental procedures. The production process also needs to comply with the Medical Device Rules, 2017, which have been defined for Class C Medical devices.

Fees for manufacturing license for Dental Anaesthesia Syringe Cartridge

For a device that falls under Class C risk category, the appropriate license is MD9. The fee for obtaining MD9 license is Rs. 50,000, with an additional cost of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Dental Anaesthesia Syringe Cartridge?

A manufacturing license is a mandatory requirement for producing the Dental Anaesthesia Syringe Cartridge. Ensuring quality and safety in medical device production, it helps regulatory bodies maintain the trust of consumers and assure them about the safety of medical products. It also shields consumers and patients from substandard and potentially harmful medical devices.

Steps to Obtain a CDSCO Manufacturing License for Dental Anaesthesia Syringe Cartridge

Before applying for a manufacturing license, manufacturers need to have certain pre-requisites and documents ready. These include Device Master File, Quality Management Certificate, specific details about the medical device and the site details. After preparation and submission of these documents, the application undergoes a scrutiny and approval process. Common handling challenges and their solutions are also a part of this process.

Frequently Asked Questions (FAQs)

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

    Ans. As per Medical Device Rules, 2017, Dental Anaesthesia Syringe Cartridge falls under the Class C risk category.

  2. Q. What license is needed to manufacture Dental Anaesthesia Syringe Cartridge?

    Ans. For manufacturing Dental Anaesthesia Syringe Cartridge, MD9 license is required.

  3. Q. What are the fees for MD9 license for Dental Anaesthesia Syringe Cartridge?

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

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

    Ans. For Class C devices like the Dental Anaesthesia Syringe Cartridge, the license is issued by CDSCO HQ located in New Delhi.

  5. Q. Is repackaging of Dental Anaesthesia Syringe Cartridge considered manufacturing?

    Ans. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Dental Anaesthesia Syringe Cartridge is also considered manufacturing requiring a license on MD9.

Conclusion

Navigating the process of obtaining a manufacturing license for medical devices can be complex and challenging. For detailed guidance on this process, refer here. If you need assistance or consultation regarding the licensing process, don't hesitate to reach out to Pharmadocx Consultants. You can visit their website here, call them at +91-7404557227, or send an email to [email protected]. They are equipped with the necessary knowledge and expertise to assist you throughout the licensing process.

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