Published on

CDSCO Manufacturing License for Dental impression material

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a paramount regulatory organization in India, controlling the regulation and authorization of import, manufacture, and distribution of drugs and medical devices. Safety, efficacy, and quality remain at the forefront of its purposes, as it ensures that all medical equipment on the market meet the necessary health requirements. Within this framework, manufacturing licenses play a critical role, acting as a seal of approval, verifying that a particular device has met the necessary standards prescribed by the authorities.

In the realm of dental healthcare, the Dental impression material stands as an essential piece of equipment, facilitating a fundamental part of the dental treatment process. As it is used for making an oral impression, it holds substantial medical significance, which makes understanding its manufacturing process and licensing extremely important. You can find further information on the CDSCO's portal here.

What is Dental Impression Material?

Dental impression material, as its name suggests, is a substance used to obtain a detailed impression or the replicate of a person's dentition and the surrounding tissues. They serve as a mold to prepare the restoration, prosthetics or model of the oral cavity.

In dental procedures, an accurate impression of the patient's mouth is indeterminate to producing precise dental prosthetics. Impression materials generally consist of elastic hydrocolloid materials such as agar, alginate, polysulfide, silicone, rubber based materials, and gypsum.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been dedicated to ensuring the safety, efficacy, and quality of drugs and medical devices within the country. The objective has been to benefit the public by granting them access to reliable and high-quality medication and equipment.

CDSCO has developed a systematic regulatory framework for the oversight of medical devices. This encompasses classifications of medical devices, requirements for manufacturing, importing, registration, and standards for quality and safety. The dental impression material is regulated under this framework, ensuring it's safe and effective use.

How to Manufacture Dental Impression Material

The manufacturing process of dental impression material requires precision, tailoring the material to fit the specific requirements of dental procedures. It necessitates a complex mix of chemical composition to ensure the material is flexible for easy molding, yet sturdy for a precise impression.

Fees for Manufacturing License for Dental Impression Material

Dental Impression Material falls under risk Class B, and as such, a MD5 license is required for its manufacturing. The fees for obtaining an MD5 license are Rs. 5,000 for the license itself, with an additional cost of Rs. 500 per product.

Why is a Manufacturing License Necessary for Dental Impression Material?

A manufacturing license is an assertion of quality, safety, and compliance to the defined standards. It generates confidence among consumers and healthcare professionals in the efficacy of the product. In the context of medical devices like the Dental Impression Material, it also ensures professional accountability and transparency.

Without a valid manufacturing license, there is a profound risk of consumers and patients exposed to substandard, faulty, or ineffective medical devices causing potential harm. Thus, a manufacturer is obligated to obtain a manufacturing license before releasing the product into the market.

Steps to Obtain a CDSCO Manufacturing License for Dental Impression Material

The process encompassing grant of a license involves several steps. Firstly, the manufacturer has to prepare a complete set of documents including the Device Master File, Quality Management Certificate, Device Details, Site details etc.

Once the documentation is in order, an application is lodged for the license. CDSCO's rigorous assessment then follows this, after which license approval is granted if all criteria are met. The procedure is exhaustive and might pose challenges. However, professional assistance and proper consultation can help overcome these hurdles.

Frequently Asked Questions (FAQs)

  1. What is risk class of Dental Impression Material as per Medical Device Rules, 2017?
    The Dental Impression Material falls under risk Class B.

  2. What license is needed to manufacture Dental Impression Material?
    The manufacture of Dental Impression Material requires an MD5 license.

  3. What is fees for MD5 license for Dental Impression Material?
    The fees for an MD5 license for Dental Impression Material is Rs. 5,000 for the license and Rs. 500 per product.

  4. Who will issue a manufacturing license for Dental Impression Material?
    For Class B devices like Dental Impression Material, the state FDA will issue the license.

  5. Is repackaging of Dental Impression Material 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Dental Impression Material is also considered manufacturing requiring an MD5 license.

Conclusion

Obtaining the necessary manufacturing license for the Dental impression material might seem daunting at first. Still, with the right guidance and tools, the procedure can be navigated smoothly. For professional consultation or assistance regarding obtaining a CDSCO Manufacturing License, you can reach out to Pharmadocx Consultants, call at +91-7404557227 or email at [email protected]. Also, for more details on MD5 licensing, follow this link.

cdsco import license in india banner
cdsco manufacturing license in india banner