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CDSCO Manufacturing License for Electromechanical orthopaedic extracorporeal shock wave therapy system

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's main regulatory body overseeing the safety, efficacy, and quality of drugs and medical devices. The organization's responsibilities involve granting approvals for new drugs and medical devices, conduct clinical trials, lay down the standards for drugs, control over the quality of imported drugs and coordination of the activities of State Drug Control Organizations.

The medical device industry relies heavily on regulations and licenses. With a myriad of medical devices in the market, ranging from simple bandages to complex pacemakers, manufacturing licenses provide a standardized measure of quality and safety for the end users.

In this blog post, we'll introduce the manufacturing of Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System and the crucial role CDSCO plays in this domain. Want to know more about the CDSCO and its functions? Visit the official website here.

What is Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System?

An Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System (OEST), is a medical device specifically designed to deliver shock wave therapy for the treatment of musculoskeletal disorders. This noninvasive treatment utilizes shock waves to promote the body's healing processes and improve function and wellbeing.

Common procedures using this device include the treatment of chronic musculoskeletal conditions, such as plantar fasciitis, tennis elbow and shoulder rotator cuff pain.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a pivotal role in ensuring the quality, safety, and efficacy of drugs and medical devices in India. The organization is entrusted with the responsibility of creating and implementing medical device regulation in the country.

Under the umbrella of CDSCO, medical device regulation involves controlling the manufacture, import, investigation and distribution of drugs and medical devices, to ensure that they meet the necessary quality standards.

How to manufacture an Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System

Manufacturing a complex device such as an OEST requires adherence to stringent regulatory guidelines, meticulous attention to standards for safety and efficacy and a robust quality management system.

Fees for manufacturing license for Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System

As a class C medical device, an Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System requires an MD9 license for manufacture. The fee for an MD9 license is Rs. 50,000, plus an additional fee of Rs. 1,000 per product. More details about MD9 licensing can be found here.

Why is a Manufacturing License Necessary for an Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System?

Obtaining a manufacturing license is not just a statutory requirement. It is critical to ensuring that quality and safety standards are maintained during the production and distribution of medical devices. A valid license signifies that the product has been tested and verified to meet essential regulatory compliance. It also protects patients and healthcare providers from substandard or counterfeit products.

Steps to Obtain a CDSCO Manufacturing License for an Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System

  1. Ensure you have the Device Master File, Quality Management Certificate, Device Details, Site details and other necessary documents.
  2. Submit your application with the required fees and documentation.
  3. The regulating authorities will review your application.
  4. Upon successful review, your license will be granted.

Overcoming common challenges in the application process requires a thorough understanding of the regulatory framework and meticulous attention to detail in documenting and submitting the necessary information.

Frequently Asked Questions (FAQs)

  • Q: What is the risk class of Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System as per Medical Device Rules, 2017? A: The risk class for the Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System is C.

  • Q: What license is needed to manufacture Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System? A: An MD9 license is required to manufacture Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System.

  • Q: What is the fees for MD9 license for Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System? A: The fee for an MD9 license is Rs. 50,000, plus an additional fee of Rs. 1,000 per product.

  • Q: Who will issue the manufacturing license for Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System? A: The CDSCO HQ in New Delhi will issue the MD9 license.

  • Q: Is repackaging of Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System considered manufacturing? A: Yes, repackaging of the Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System is considered manufacturing as per the Drugs and Cosmetics Act, requiring an MD9 license.

Conclusion

Despite regulatory complexities, obtaining a CDSCO manufacturing license is a feasible task with the right guidance. For further assistance and consultation regarding the licensing process, reach out to Pharmadocx Consultants or call them directly at +91-7404557227. If email suits you better, no problem - simply drop them a line at [email protected] and they'll swiftly attend to your queries.

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