Published on

CDSCO Manufacturing License for Cardiopulmonary bypass arterial line blood filter

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex drug regulatory authority in India. It lays down standards and measures for ensuring safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices in the country. A crucial aspect of CDSCO regulations is the manufacturing licensing of these items, especially medical devices.

This blog aims to dive deeper into the manufacturing license of a specific medical device - the Cardiopulmonary Bypass Arterial Line Blood Filter. This medical device plays a significant role in cardiovascular procedures, and obtaining the appropriate manufacturing license is essential to its production.

To gather more information and regulations, you can visit the official CDSCO's portal.

What is Cardiopulmonary Bypass Arterial Line Blood Filter?

A Cardiopulmonary Bypass Arterial Line Blood Filter is a medical device used as part of a gas exchange system. Its purpose is to filter non-biological particles and emboli (these refer to blood clots or foreign material in the bloodstream likely to block a vessel) out of the blood during the cardiovascular procedure. These medical devices are integral to therapies and procedures related to heart or lung difficulties.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a pivotal role in overseeing the healthcare sector in India. It assures that the standards of drugs and medical devices align with international standards. The regulatory framework set by CDSCO for medical devices ensures that these devices are effective and safe for usage.

How to manufacture Cardiopulmonary Bypass Arterial Line Blood Filter

Manufacturing medical devices like the Cardiopulmonary Bypass Arterial Line Blood Filter requires meticulous adherence to guidelines and regulations. Adherence to quality standards and meeting the specifications is crucial.

Fees for Manufacturing License for Cardiopulmonary Bypass Arterial Line Blood Filter

Being a Class C medical device, the license required for a Cardiopulmonary Bypass Arterial Line Blood Filter is MD9, the fee for which is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Needed for Cardiopulmonary Bypass Arterial Line Blood Filter?

A manufacturing license is mandatory for producing any medical device, including the Cardiopulmonary Bypass Arterial Line Blood Filter. It ensures that the medical devices meet safety and quality standards and protects consumers from substandard products. Compliance with these regulations is of paramount importance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Cardiopulmonary Bypass Arterial Line Blood Filter

Getting a manufacturing license involves a series of steps:

  1. Collect the necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the documents to the relevant authority
  3. Follow the due process, which may involve verifications and approvals
  4. Overcome challenges that might arise during the process

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Cardiopulmonary Bypass Arterial Line Blood Filter as per Medical Device Rules, 2017?

The Cardiopulmonary Bypass Arterial Line Blood Filter falls under Risk Class C as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Cardiopulmonary Bypass Arterial Line Blood Filter?

The license needed to manufacture the Cardiopulmonary Bypass Arterial Line Blood Filter is MD9.

Q3. What is the fee for MD9 license for Cardiopulmonary Bypass Arterial Line Blood Filter?

The fee for the MD9 license for Cardiopulmonary Bypass Arterial Line Blood Filter is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Cardiopulmonary Bypass Arterial Line Blood Filter?

The manufacturing license for a class C device like the Cardiopulmonary Bypass Arterial Line Blood Filter will be issued by the CDSCO HQ in New Delhi.

Q5. Is repackaging of Cardiopulmonary Bypass Arterial Line Blood Filter considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Therefore, repackaging of Cardiopulmonary Bypass Arterial Line Blood Filter is also considered manufacturing requiring a license on MD9.

Conclusion

The regulatory guidelines surrounding the manufacturing and disposal of medical devices can be complex and confusing. If you're seeking professional help regarding the licensing process, contact Pharmadocx Consultants. You can visit their website or call "+91-7404557227" or email at "[email protected]". For more details about MD9, you can visit this page.

Remember, securing the right guidance can make the procedure of obtaining a manufacturing license less tedious and ensure your business's smooth sailing.

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