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CDSCO Manufacturing License for External transcutaneous cardiac pacemaker

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. With the mandate to protect and promote public health in India, CDSCO's fundamental role is the standardization and regulation of drugs, cosmetics, medical devices, clinical trials, and diagnostics. CDSCO plays a pivotal role in ensuring the quality of medical devices and patient safety.

Manufacturing licenses occupy a vital position in the medical device industry, as they ensure compliance with requisite norms and standards. A manufacturing license not only validates a manufacturer's adherence to required regulations but also infuses trust in medical professionals and patients regarding the safety, efficiency, and quality of the medical device.

This article focuses on the External Transcutaneous Cardiac Pacemaker, a unique medical device with significant therapeutic implications. More specifically, this blog post discusses the CDSCO manufacturing license associated with the production of this life-saving device. You can find extensive information regarding licensing and medical devices on CDSCO's official portal here.

What is an External Transcutaneous Cardiac Pacemaker?

An external transcutaneous cardiac pacemaker is a non-invasive medical device applied to the chest's surface through electrodes or defibrillator paddles. This device's primary function is to supply a periodic electrical pulse intended to synchronize the heart rhythm.

These pacemakers are commonly utilized in emergency medical procedures to restore a normal heart rhythm during cardiac events such as arrhythmias, heart blockages, and cardiac arrest.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a rich history in Indian healthcare regulation characterized by robust conviction in public health protection and promotion. The organization's mission primarily revolves around ensuring the effective regulation of drugs, cosmetics, and medical devices in India.

One crucial aspect of the CDSCO's regulatory framework is medical device regulation. The effort aims to regulate medical devices' manufacturing, sale, and distribution, ensuring standardisation, and reassuring the quality, efficacy, and safety of these products.

How to Manufacture an External Transcutaneous Cardiac Pacemaker

The manufacturing process of an external transcutaneous cardiac pacemaker consists of design and development, production, assembly, and testing phases. It should be noted that each phase demands absolute adherence to specified regulations and quality control norms to ensure the device's effective performance and patient safety.

Fees for Manufacturing License for an External Transcutaneous Cardiac Pacemaker

As per the risk classification, the manufacturing license needed for an external transcutaneous cardiac pacemaker, classified under Class C, is MD9. The fee for obtaining an MD9 license is Rs. 50,000, with a supplementary charge of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an External Transcutaneous Cardiac Pacemaker?

Securing a manufacturing license for a medical device is mandatory; it ensures compliance with regulations, promotes patient safety, and validates the quality of the device in question.

The manufacturing license also protects consumers and patients from substandard products by ensuring adherence to requisite quality standards and norms. In essence, it forms a basis for trust in the healthcare sector by encouraging transparency and accountability in medical device manufacturing.

Steps to Obtain a CDSCO Manufacturing License for an External Transcutaneous Cardiac Pacemaker

  • Submission of required documentation like Device Master File, Quality Management Certificate, device and site details, among others.
  • Filing of the application to CDSCO.
  • Review of the application by CDSCO
  • issuance of license upon successful review

While the process seems straightforward, it is peppered with challenges. Getting expert assistance will help you navigate these obstacles with ease.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of an External Transcutaneous Cardiac Pacemaker as per Medical Device Rules, 2017?

Answer: The External Transcutaneous Cardiac Pacemaker falls under Risk Class C as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture an External Transcutaneous Cardiac Pacemaker?

Answer: To manufacture an External Transcutaneous Cardiac Pacemaker, an MD9 License is required.

Q3. What are the fees for the MD9 license for an External Transcutaneous Cardiac Pacemaker?

Answer: The fees for MD9 License for an External Transcutaneous Cardiac Pacemaker is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for an External Transcutaneous Cardiac Pacemaker?

Answer: The manufacturing license for Class C devices, like the External Transcutaneous Cardiac Pacemaker, is issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of an External Transcutaneous Cardiac Pacemaker considered manufacturing?

Answer: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are considered drugs, repackaging of an external transcutaneous cardiac pacemaker also requires an MD9 License.

Conclusion

Seeking assistance from experts for the licensing process is always a prudent decision. For consultation or help regarding the CDSCO manufacturing license process, please reach out to Pharmadocx Consultants at https://www.pharmadocx.com, or call at +91-7404557227, or drop an email at [email protected].

If you want to know more about the process involved in obtaining the MD9 license needed to manufacture an External Transcutaneous Cardiac Pacemaker, refer to this blog post.

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