Published on

CDSCO Manufacturing License for Transgingival implant

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standards Control Organization (CDSCO) holds a key position in the thriving healthcare sector of India. Governed by the Directorate General of Health Services and the Ministry of Health and Family Welfare, CDSCO plays a critical role in safeguarding and enhancing public health. CDSCO's primary functions involve the regulation of import, approval of new drugs, clinical trials, laying down standards for drugs and medical devices, and controlling over the quality of drugs and medical devices in the country.

In the medical device industry, manufacturing licenses play a pivotal role. These licenses guarantee that the manufacturing processes adhere to the stringent standards specified by health authorities to ensure the safety and effectiveness of medical devices. This article centers around the Transgingival implant, a Class C medical device, and the CDSCO manufacturing license mandatory for its production in India.

The Transgingival implant is a significant medical device used in dentistry. It plays a crucial role in prosthetic dentistry and helps restore the functionality and aesthetics of the oral cavity. For more information about CDSCO, their regulatory framework, and services, follow the link to CDSCO's portal.

What is Transgingival Implant?

Transgingival implants are dental medical devices designed to be implanted surgically through the oral mucosa and gingiva. They serve as an anchor and provide support for dental prostheses. These implants generally are made of materials like titanium which ensure their durability and compatibility with the human body.

Transgingival implants are predominantly used in prosthetic dentistry for the replacement of missing teeth. These implants provide an alternative to traditional dentures or bridges, offering a more long-term and functional solution.

The Role of CDSCO in Medical Device Regulation

The CDSCO is an entity that plays a strategic role in the healthcare sector. The organization is tasked with the responsibility of maintaining and improving public health in India. The CDSCO's responsibilities span supervision of the quality of drugs and medical devices, approval of new drugs, clinical trials, and import regulations among many other functions.

The CDSCO's regulatory framework for medical devices focuses on safety, performance, and quality. This framework classifies medical devices into four categories—Classes A, B, C, and D—based on their level of risk, with Class A being the lowest and Class D being the highest.

How to manufacture Transgingival Implant

Manufacturing a Transgingival Implant requires a CDSCO license and adherence to specific guidelines in accordance with the Class C risk category. This process involves developing a device master file, obtaining a quality management certificate, and providing comprehensive details about the device and the manufacturing site.

Fees for Manufacturing License for Transgingival Implant

Fees for acquiring the manufacturing license for a Class C medical device such as Transgingival Implant entail a license fee of Rs. 50,000 and an additional fee of Rs. 1,000 per product. This fee structure applies to the MD9 license applicable for Class C medical devices. For more information, please check out this article at Pharmadocx.

Why is a Manufacturing License Necessary for Transgingival Implant?

A manufacturing license for the Transgingival Implant is more than just a regulatory requirement. It is crucial for ensuring the quality and safety of the medical device. The license ensures that manufacturers adhere to pre-determined quality standards during the production of the devices.

Further, acquiring a license demonstrates regulatory compliance in the healthcare sector. This not only builds trust with regulatory authorities but is also pivotal for protecting patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Transgingival Implant

Obtaining a CDSCO manufacturing license for Transgingival Implants requires meeting certain pre-requisites and submitting various documents. These include a Device Master File, Quality Management Certificate, Device Details, and manufacturing Site Details, amongst others.

The license procedure covers from submission to approval, with primary stages involving filling up the application, payment of the necessary fees, and facing CDSCO inspections. Challenges that may arise in the process include ensuring compliance with all CDSCO regulations and managing the paperwork efficiently.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Transgingival Implant as per Medical Device Rules, 2017?

A1: Transgingival Implant comes under Class C as per Medical Device Rules, 2017.

Q2: What license is needed to manufacture Transgingival Implant?

A2: An MD9 license is required for the manufacturing of Transgingival Implant.

Q3: What is the fee for an MD9 license for Transgingival Implant?

A3: The fee for an MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for Transgingival Implant?

A4: For Class C devices like Transgingival Implant, CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of Transgingival Implant considered manufacturing?

A5: 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 Transgingival Implant is also considered manufacturing requiring a license on MD9.

Conclusion

Understanding and implementing the CDSCO medical device regulatory framework can be a complex task. To ensure comprehensive compliance with the rules and regulations, professional consultation can be beneficial. For any assistance regarding the licensing process for medical devices, feel free to reach out to Pharmadocx Consultants. You can call us on +91-7404557227 or email us at [email protected] for consultation and guidance.

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