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CDSCO Manufacturing License for Pacemaker lead adaptor

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Introduction

The myriad of activities that keep the drugs and medical devices sector afloat in India are coordinated by the Central Drugs Standard Control Organization (CDSCO). This apex organization has a pivotal role in maintaining the safety, efficacy and quality of these critical products, ensuring that they adhere to the laid out regulatory and statutory requirements. Notably, various licenses are required for the manufacturing and distribution of medical devices, showcasing the significance of strict regulatory compliance in the healthcare industry.

A prime example of a medical device that features distinctively in the healthcare landscape is the Pacemaker Lead Adaptor, a device that has proven vital over the years. For information, queries and various services related to the acquisition of licences in India, one can visit the CDSCO's online portal here.

What is a Pacemaker Lead Adaptor?

A Pacemaker Lead Adaptor is a life-saving device that is used to modify a pacemaker lead, enabling it to connect to a pacemaker pulse generator created by another manufacturer. This is of paramount importance in the cardiovascular medical field, especially when addressing the heart's rhythmicity issues.

Commonly, this device is used in procedures related to installing, adjusting or replacing pacemaker systems, where interoperability between different manufacturers' products is necessary.

The Role of CDSCO in Medical Device Regulation

Throughout its existence, the CDSCO has persistently worked towards ensuring that all medical devices, including the Pacemaker Lead Adaptor, align with the required quality and safety standards. This is accomplished through their encompassing regulatory framework, which includes definition and classification of medical devices, granting of licenses, post-market surveillance, among other critical roles.

How to manufacture a Pacemaker Lead Adaptor

If you are considering entering the health market with this product, note that it falls under Class C of medical devices, hence you'll require an MD9 manufacturing license.

Fees for manufacturing license for a Pacemaker Lead Adaptor

For an MD9 license, the fees stand at Rs. 50,000 for the license and an additional Rs. 1,000 for each individual product.

Why is a Manufacturing License Necessary for Pacemaker Lead Adaptor?

In as much as obtaining a manufacturing license is legally mandatory, it plays a more critical role in ensuring that the devices are of the specified quality and safe for use by patients. This eventually shields consumers from substandard products and upholds the credibility of the healthcare industry.

Steps to Obtain a CDSCO Manufacturing License for Pacemaker Lead Adaptor

There are a number of key requirements needed in the application process for the license, such as a Device Master File, Quality Management Certificate, Device Details, and Site details. After gathering these, you submit your application and wait for the approval. Should you encounter any challenges, it's advisable to seek professional help. For more information on the MD9 license, click on this link.

Frequently Asked Questions (FAQs)

  1. Q: What is risk class of Pacemaker Lead Adaptor as per Medical Device Rules, 2017?
    A: It falls under Risk Class C.
  2. Q: What license in needed to manufacture a Pacemaker Lead Adaptor?
    A: An MD9 license is required to manufacture a Pacemaker Lead Adaptor.
  3. Q: What is fees for MD9 license for a Pacemaker Lead Adaptor?
    A: The fees stand at Rs. 50,000 for the license and Rs. 1,000 per individual product.
  4. Q: Who will issue manufacturing license for a Pacemaker Lead Adaptor?
    A: The manufacturing license for class C medical devices like the Pacemaker Lead Adaptor is issued by the CDSCO HQ in New Delhi.
  5. Q: Is repackaging of a Pacemaker Lead Adaptor considered manufacturing?
    A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of a Pacemaker Lead Adaptor is also considered manufacturing requiring a license on MD9.

Conclusion

Should you require any assistance or consultation regarding the licensing process, we implore you to reach out to Pharmadocx Consultants through their website, or by calling on "+91-7404557227", or emailing "[email protected]". Experts in the field are ready to make your journey a success!

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