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CDSCO Manufacturing License for Bite registration rim wax, plate

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Introduction

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, plays an instrumental role in setting safety protocols, product approvals, and regulations for the medical device industry in India. A pivotal part of their functions involves granting manufacturing licenses to ensure that all medical devices manufactured conform to the laid down safety norms.

Manufacturing licenses in the medical device industry play a vital role. They serve as a hallmark of quality, ensuring that these devices are produced under stringently controlled conditions.

In this context, we look at Bite registration rim wax, plate - a commonly used dental material in the healthcare sector. This device is mainly used for registration of jaw relation by dental professionals.

For more details on manufacturing licenses and regulations for devices like this, one can refer to CDSCO's portal here.

What is Bite Registration Rim Wax, Plate?

Bite registration rim wax or plate is a modelling wax used in the dental industry. It is available as pre-fabricated plates of wax, sometimes accompanied with reinforcing foils made of metal or polymer. These wax plates are used by dentists for registering jaw relation, making bite rims.

It is an indispensable tool for many dental procedures, playing a crucial role in achieving precise dental restorations.

The Role of CDSCO in Medical Device Regulation

Established with a mission to uphold the quality of drugs and medical devices in India, CDSCO takes upon the responsibility of regulating medical devices under its ambit. It provides a regulatory framework that is designed to ensure the safety and effectiveness of medical devices produced and marketed in India.

How to Manufacture Bite Registration Rim Wax, Plate

Manufacturing Bite Registration Rim Wax, Plate falls under Medical Device Risk Class B. Hence, the manufacturers have to comply with MD5 license requirements as per CDSCO guidelines.

Fees for Manufacturing License for Bite Registration Rim Wax, Plate

To manufacture Bite Registration Rim Wax, Plate, an MD5 license is required. The fees for this license is Rs. 5,000, and an additional Rs. 500 per product manufactured.

Why is a Manufacturing License Necessary for Bite Registration Rim Wax, Plate?

A manufacturing license is mandatory for any medical device, including bite registration rim wax, plate. This license ensures quality and safety in medical device production. It mandates regulatory compliance within the healthcare sector, protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Bite Registration Rim Wax, Plate

The process of obtaining a manufacturing license involves the following steps:

  1. Prepare pre-requisites and documentation such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application for the license.
  3. Await approval from the authority.
  4. Navigate any potential challenges that arise with due diligence.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Bite registration rim wax, plate as per Medical Device Rules, 2017?

  • Class B.

Q2: What license is needed to manufacture Bite registration rim wax, plate?

  • MD5.

Q3: What are the fees for an MD5 license for Bite registration rim wax, plate?

  • Rs. 5,000 for the license and Rs. 500 per product.

Q4: Who will issue the manufacturing license for Bite registration rim wax, plate?

  • For Class A sterile and measuring & Class B devices - state FDA will issue the license, For class C & D - CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of Bite registration rim wax, plate considered manufacturing?

  • 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. Hence, repackaging of Bite registration rim wax, plate is also considered manufacturing requiring a license on MD5.

Conclusion

Obtaining a manufacturing license for medical devices can be complicated and time-consuming, but we're here to help. Reach out for consultation or assistance regarding the licensing process to Pharmadocx Consultants or call "+91-7404557227" or email to "[email protected]".

For your resource on MD5 license, click here.

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