CDSCO Manufacturing License for Medium-wave diathermy treatment system

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a cornerstone in the realm of healthcare in India. The key functions of CDSCO encompass regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of certain licenses as Central License Approving Authority.

Consequently, licenses play an indispensable role in the medical device industry. They ensure adherence to safety standards, thus shielding patients and consumers from substandard products. Our point of discussion, the Medium-wave diathermy treatment system, is an eminent figure in the medical devices market. It is a testament to how medical technology can revolutionize patient care and treatment methodology. You can learn more about its functionalities and regulatory requirements at CDSCO's portal here.

• What is Medium-wave Diathermy Treatment System?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture a Medium-wave Diathermy Treatment System
• Fees for Manufacturing License for Medium-wave Diathermy Treatment System
• Why is a Manufacturing License Necessary for the Medium-wave Diathermy Treatment System?
• Steps to Obtain a CDSCO Manufacturing License for Medium-wave Diathermy Treatment System
• Frequently Asked Questions (FAQs)
• Conclusion

What is Medium-wave Diathermy Treatment System?

The Medium-wave diathermy treatment system is an innovative medical device designed for the specific purpose of producing therapeutic deep heat within the body. It achieves this through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 MHz to 1 MHz.

The Medium-wave diathermy treatment system is widely used in physical therapy and rehabilitation centres. It brings relief to patients suffering from arthritis, neuritis, sprains, strains, and other muscular-related pains by stimulating deep into affected tissues.

The Role of CDSCO in Medical Device Regulation

The inception of CDSCO was driven by the mission to assure the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and medical devices in India. It is an integral part of the Indian administrative machinery for healthcare.

CDSCO has crafted a robust regulatory framework for medical devices to ensure they meet strict quality and safety standards. The Medium-wave diathermy treatment system falls under this framework and must comply with CDSCO's regulations to be accepted for manufacturing and sale in India.

How to Manufacture a Medium-wave Diathermy Treatment System

Manufacturing a Medium-wave diathermy treatment system involves standard procedures that must comply with regulatory and quality standards. CDSCO requires a manufacturing license, which can be obtained after meeting all pre-requisite criteria and successful submission of required documents.

Fees for Manufacturing License for Medium-wave Diathermy Treatment System

As a Class B medical device, a Medium-wave diathermy treatment system requires an MD5 license for manufacturing. The fee structure for the MD5 license includes a base fee of Rs. 5,000 for the license and an additional Rs. 500 per product. Here are more details about the MD5 license.

Why is a Manufacturing License Necessary for the Medium-wave Diathermy Treatment System?

It is mandatory to obtain a manufacturing license to produce a medical device such as the Medium-wave Diathermy Treatment System. The licensing process serves as a safeguard, ensuring that all medical device manufacturers adhere to global quality and safety standards. It protects consumers and patients from substandard products and guarantees regulatory compliance within the healthcare sector of India.

Steps to Obtain a CDSCO Manufacturing License for Medium-wave Diathermy Treatment System

To acquire a CDSCO manufacturing license for a Medium-wave diathermy treatment system, an applicant needs to follow these steps:

• Submit the required documents, including the Device Master File, Quality Management Certificate, Device Details, and Site details.

• Complete the application process by filling up the forms, submitting the documents, and paying the fees.

• Once your application has been processed, it is subjected to review and scrutiny. If no clarifications are required, the application is forwarded for approval.

• After receiving approval, the manufacturer can then proceed with production.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of Medium-wave diathermy treatment system as per Medical Device Rules, 2017?
   A: The Medium-wave diathermy treatment system is classified as a Class B medical device.

2. Q: What license is needed to manufacture a Medium-wave diathermy treatment system?
   A: You will need an MD5 license to manufacture a Medium-wave diathermy treatment system.

3. Q: What is the fee for an MD5 license for a Medium-wave diathermy treatment system?
   A: The fee for an MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

4. Q: Who will issue the manufacturing license for Medium-wave diathermy treatment system?
   A: Since the Medium-wave diathermy treatment system is a Class B medical device, the state FDA will issue the license.

5. Q: Is repackaging of Medium-wave diathermy treatment system considered manufacturing?
   A: Yes, repackaging of the Medium-wave diathermy treatment system, like other medical devices, constitutes manufacturing and requires an MD5 license.

Conclusion

Understanding the path to obtain a manufacturing license can be a complex, rigorous process. However, we are here to make the journey simpler. At Pharmadocx Consultants, we can guide you through every leap and hurdle, ensuring an effective license procurement process. Feel free to reach out to us for consultation or assistance regarding the licensing process here, call us at "+91-7404557227", or directly drop us an email here.