Published on

CDSCO Manufacturing License for Bone cement accessories

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

Welcome to our discussion on the Central Drugs Standard Control Organization (CDSCO) and its crucial role in the manufacturing and licensing of medical devices in India. CDSCO, under the Ministry of Health and Family Welfare, is the central regulatory authority responsible for the approval of new drugs, controlling clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations, and providing guidance to the Indian Pharmaceutical industry.

Manufacturing licenses play a pivotal role in the medical device industry. With a license, producers are ensured of the quality and safety of their products while consumers get a guarantee of the performance and reliability of these devices. The medical device in focus today is the Bone Cement Accessories, an essential player in the surgery field, particularly in the Orthopaedic domain.

To obtain any further detailed information on licensing and regulations, we suggest you refer to CDSCO's portal at CDSCO portal

What are Bone Cement Accessories?

Bone Cement Accessories are devices used in conjunction with bone cement to facilitate its handling and penetration into a bone site. These specialized devices include scrubbing and drying tools for a bone cavity, plugging tools to contain cement in the desired location, hand- or vacuum-mixing devices for cement, cement insertion tools for the prepared cavity, and devices for pressurizing cement to ensure adhesion to the bone.

Common procedures calling for the use of Bone Cement Accessories include orthopaedic surgeries such as joint repair and replacement. These medical devices play a pivotal role in these procedures, allowing for cement to be accurately delivered and ensuring that prosthetics are firmly anchored to the bone.

The Role of CDSCO in Medical Device Regulation

The establishment of CDSCO marked a significant step forward in the regulation of medical devices in India. Its mission is to guarantee the safety, efficacy, and quality of drugs, cosmetics, and all medical devices intended for human use and consumed in India. The primary function of CDSCO is the enforcement of the Drugs and Cosmetics Act, alongside its rules and notifications, in India.

CDSCO's regulatory framework for medical devices sets stringent standards for manufacturing, selling, importing, and using medical devices. Its primary objective is to safeguard public health by ensuring that all medical devices that make their way to the market are safe and effective for their intended use.

How to manufacture Bone Cement Accessories

The manufacturing of Bone Cement Accessories falls within Risk Class B, as per the Medical Device Rules, 2017. The devices need to be produced under controlled conditions that ensure they comply with all necessary safety and quality standards set by CDSCO.

For manufacturing the Bone Cement Accessories, it is also essential to strictly adhere to Good Manufacturing Practices (GMP). This adherence not only ensures the quality of the product but also guarantees safety while handling and using these devices.

Fees for manufacturing license for Bone Cement Accessories

Manufacturing License for Class B medical devices, including bone cement accessories, requires an MD5 license. The fees for the MD5 license are Rs. 5,000 along with an additional fee of Rs. 500 per product.

Further details about the licensing process and fees can be found in this article here.

Why is a Manufacturing License Necessary for Bone Cement Accessories?

Obtaining a manufacturing license is mandatory for producing Bone Cement Accessories. This pre-requisite is not only crucial to maintaining the quality and safety of medical devices but also plays a significant role in regulatory compliance within the healthcare sector.

Manufacturing licenses protect consumers and patients from substandard and potentially harmful products. It reflects the manufacturer's efforts to safeguard public health by abiding by the stringent manufacturing standards set by regulatory authorities.

Steps to Obtain a CDSCO Manufacturing License for Bone Cement Accessories

Obtaining a manufacturing license from CDSCO involves multiple steps and thorough documentation. The essential documents required for the application process include the Device Master File, Quality Management Certificate, Device Details, Site details, and more.

The licensing procedure is a combination of submission, verification, inspection, and final approval, which requires patience and attention to detail. The application must be submitted meticulously, ensuring all provided information is accurate and current.

Overcoming the challenges in obtaining a manufacturing license often involves having a clear understanding of the regulations, getting the necessary consultancy, and practicing stringent quality control.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Bone Cement Accessories as per Medical Device Rules, 2017?
The risk class of Bone Cement Accessories is Class B.

Q2. What license is needed to manufacture Bone Cement Accessories?
The MD5 license is needed to manufacture Bone Cement Accessories.

Q3. What is the fee for the MD5 license for Bone Cement Accessories?
The fee for the MD5 license is Rs. 5,000 for the license itself and additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Bone Cement Accessories?
The State's Food and Drug Administration (FDA) issues the manufacturing license for Bone Cement Accessories.

Q5. Is repackaging of Bone Cement Accessories considered manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of the Drug Act only, and hence repackaging of Bone Cement Accessories is considered manufacturing, requiring an MD5 license.

Conclusion

Navigating through the numerous rules and regulations around CDSCO medical device licensing can be daunting. We understand this and are here to help. At Pharmadocx Consultants, we provide expert guidance and assistance during the licensing process. Feel free to reach out to us at Pharmadocx Consultants, you can also call us at +91-7404557227 or email us at [email protected] for any queries or assistance.

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