Published on

CDSCO Manufacturing License for Short-wave diathermy treatment system

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. Its primary functions include approving new medical products, controlling the quality of imported medicines, ensuring the quality of the testing laboratories and setting standards for medicines, medical devices and cosmetics. Furthermore, it also regulates the market authorization of new drugs and clinical trials standards.

In the medical device industry, obtaining a manufacturing license is crucial. It provides the leverage of legal manufacturing, and ensures the quality and safety of the produced devices. The manufacturing process of medical devices strictly adheres to certain licensure conditions which are regulated by regulatory bodies like CDSCO, to maintain high standards of patient safety. Licensing ensures regulatory compliance in the healthcare industry, which is pivotal in protecting patients and consumers from inferior quality products.

The medical device in focus here is the Short-wave diathermy treatment system. It is used in providing therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 13 MHz to 27.12 MHz.

For further information, you can head over to the CDSCO's portal.

What is a Short-wave diathermy treatment system?

A Short-wave diathermy treatment system falls under the category of rehabilitation devices. The system works by providing therapeutic deep heat within certain volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the RF bands of 13 MHz to 27.12 MHz. It has proven considerably beneficial in the therapeutic treatment of muscle and joint conditions.

This device is commonly used to treat conditions like arthritis, fibromyalgia, and back pain. It has also been used to treat sports injuries and in postoperative rehabilitation.

The Role of CDSCO in Medical Device Regulations

The CDSCO plays a crucial role in the regulation of medical devices in India, including the Short-wave diathermy treatment system.

The role of CDSCO extends far beyond simple regulatory control. The mission of CDSCO includes the assurance of safety, efficacy, and quality of drugs, cosmetics and medical devices. It oversees the regulatory framework for medical devices under which the standards and guidelines for their production, distribution, and use are defined.

How to manufacture a Short-wave diathermy treatment system

Manufacturing a Short-wave diathermy treatment system involves specific steps and processes that comply with the regulations of CDSCO. The manufacturing process must fulfill all stipulated guidelines, ensuring the produced devices are of high quality and safe for use.

Fees for manufacturing license for a Short-wave diathermy treatment system

As the Short-wave diathermy treatment system is categorized under Risk Class C, the required license is MD9. The fees for obtaining an MD9 license is Rs. 50,000 for the license and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Short-wave diathermy treatment system?

Having a manufacturing license is mandatory for the production of a Short-wave diathermy treatment system. It ensures the quality and safety of the device.

Notable highlights of having a license include enforcing regulatory compliance in the healthcare sector and protecting users from sub-par products. Consequently, having a license verifies that the producers have adhered to defined standards, which significantly contributes towards enhancing patient safety.

Steps to Obtain a CDSCO Manufacturing License for a Short-wave diathermy treatment system

Acquiring a CDSCO manufacturing license involves a thorough procedure, including pre-requisites and documentation. You must provide a Device Master File, a Quality Management Certificate, device details, site details, etc.

The application process involves submission and approval stages. Expect to encounter certain challenges, but with the right guidance, these can be easily overcome.

Frequently Asked Questions (FAQs)

  1. What is the risk class of the Short-wave diathermy treatment system as per Medical Device Rules, 2017?

The Short-wave diathermy treatment system falls under Risk Class C.

  1. What license is needed to manufacture a Short-wave diathermy treatment system?

    An MD9 license is required to manufacture a Short-wave diathermy treatment system.

  2. What is the fee for an MD9 license for a Short-wave diathermy treatment system?

    The fee for obtaining an MD9 license is Rs. 50,000, with an additional Rs. 1,000 per product.

  3. Who will issue a manufacturing license for the Short-wave diathermy treatment system?

    The MD9 license for manufacturing a Short-wave diathermy treatment system will be issued by the CDSCO HQ in New Delhi.

  4. Is repackaging of a Short-wave diathermy treatment system considered manufacturing?

    As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of any drugs (also medical devices) is considered manufacturing. Hence, repackaging of a Short-wave diathermy treatment system is also regarded as manufacturing and requires an MD9 license.

Conclusion

Securing a manufacturing license is a meticulous process. To ensure a smooth and successful procedure, we encourage you to reach out for consultation or assistance from industry experts like the Pharmadocx Consultants. Please visit their "website", call them on "+91-7404557227" or send them an email at "[email protected]" for more assistance.

You can also find more information about MD9 here

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