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CDSCO Manufacturing License for Orthodontic Adhesive

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Introduction

The Central Drugs Standard Control Organization (CDSCO) holds significant responsibility in regulating India's pharmaceutical and medical devices industries. They are the principal body concerning the safety, quality, and performance of drugs and medical devices in India. Central to CDSCO's role is the awarding of manufacturing licenses, a mandatory requirement for creating medical devices within the country.

In the realm of orthodontics, various devices are central to practitioners' work, with Orthodontic Adhesive being one. This adhesive forms a key part of the orthodontic treatment process, legitimizing its medical significance. For greater detail and essential updates in the pharmaceutical and medical device domain, please follow CDSCO's portal.

What is Orthodontic Adhesive?

Orthodontic Adhesive refers to a combined etchant and primer used in orthodontic treatment. This type of adhesive is used together with or without light curing direct bonding orthodontic adhesive. It shapes the tooth surface, enabling the alignment method to work more effectively.

Common orthodontic procedures requiring this adhesive include the attachment of brackets to teeth in the alignment process. It ensures the brackets remain fastened to the teeth during treatment.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a critical role in regulating medical devices in India as they ensure devices meet safety, quality, and performance standards. Within this regulatory framework, the CDSCO applies a classification based on potential risk. The Orthodontic Adhesive falls under class B.

How to manufacture Orthodontic Adhesive

Orthodontic adhesive manufacturing adheres to stringent standards and regulations stipulated by the CDSCO. The process requires keen attention and adherence to the technical and quality specifications outlined by the medical regulatory body. The steps to manufacture Orthodontic Adhesive involves compiling a Device Master File, acquiring a Quality Management Certificate, including Device Details, Site details, etc.

Fees for manufacturing license for Orthodontic Adhesive

Manufacturing Class B devices, such as the Orthodontic Adhesive, requires an MD5 license. The standard fee for an MD5 license is Rs. 5,000 with an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Orthodontic Adhesive?

Manufacturing licenses are mandatory to manufacture medical devices. These licenses ensure that manufacturers adhere to stringent safety and quality guideline, thereby protecting the consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Orthodontic Adhesive

Obtaining a CDSCO Manufacturing license for Orthodontic Adhesive involves a series of steps:

  • Assembling the necessary documents, which includes a Device Master File, a Quality Management Certificate, Device Details, Site details, etc.
  • Submitting the compiled documents and application through the CDSCO portal
  • Awaiting CDSCO review and approval
  • Addressing any issues or challenges that may arise from CDSCO's review

Frequently Asked Questions (FAQs)

  • Q. What is the risk class of Orthodontic Adhesive as per Medical Device Rules, 2017?
    • The Orthodontic Adhesive is a Class B medical device as per the Medical Device Rules, 2017.
  • Q. What license is needed to manufacture Orthodontic Adhesive?
    • As a Class B device, Orthodontic Adhesive requires an MD5 license for manufacturing.
  • Q. What is the fee for an MD5 license for Orthodontic Adhesive?
    • The fee for an MD5 license is Rs. 5,000. There is also a per product fee of Rs. 500.
  • Q. Who will issue the manufacturing license for Orthodontic Adhesive?
    • The state FDA issues licenses for Class B medical devices like Orthodontic Adhesive.
  • Q. Is repackaging of Orthodontic Adhesive considered manufacturing?
    • Yes, repackaging of Orthodontic Adhesive is considered as manufacturing and thus, requires an MD5 license.

Conclusion

Although the licensing process for manufacturing Orthodontic Adhesive might seem complex, it ensures safety, quality, and regulatory compliance which are key for any product in the health care sector. If you need any assistance in understanding the licensing process, feel free to reach out to Pharmadocx Consultants, who are dedicated to guiding you through this process step-by-step. Visit their website, call at "+91-7404557227", or send an email to "[email protected]" for more details.

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