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CDSCO Manufacturing License for Apexcardiograph (vibrocardiograph)

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Introduction

The Central Drugs Standard Control Organization (CDSCO) in India, under the Ministry of Health and Family Welfare, is pivotal in promoting the safety, efficacy, and quality of medical commodities that are produced inside the country or imported for the benefit of the public. Participating heavily in the regulation and control of standards, CDSCO engages in licensing, setting standards and guidelines, and prosecuting individuals and firms for violation of these standards.

The manufacturing of medical devices particularly involves many responsibilities and regulations to assure the delivery of safe, effective, and quality products. Manufacturing licenses are obtained through CDSCO, which permits organizations to manufacture, sell or distribute drugs. One such medical device going through this rigorous procedure is the Apexcardiograph(vibrocardiograph), a crucial cardiovascular device.

For a detailed understanding of these procedures, visit the official CDSCO portal here.

What is Apexcardiograph (vibrocardiograph)?

An apex cardiograph, also known as vibrocardiograph, is a medical device designed to amplify or condition the signal from an apex cardiographic transducer and provide a visual display of heart motion. This device also provides any necessary excitation energy required by the transducer.

Apexcardiographs are extensively used in medical procedures and tests involving detailed cardiovascular analysis. They play a vital role in the diagnosis and monitoring of heart diseases, especially for cases requiring constant tracking.

The Role of CDSCO in Medical Device Regulation

CDSCO's mission has always been to ensure the quality, efficacy, and safety of drugs and medical devices accessible to the public. They have been efficient in creating a comprehensive regulatory framework for licensing and regulating medical devices and implementing various health policies and standards in line with the global market.

How to manufacture Apexcardiograph (vibrocardiograph)

The manufacturing of Apexcardiograph involves several phases which are strictly monitored to ensure the production of quality devices. Ranging from the sourcing of the finest raw materials to the delivery of the finished device, each step follows stringent regulatory guidelines laid by the CDSCO.

Fees for manufacturing license for Apexcardiograph (vibrocardiograph)

The Apexcardiograph (vibrocardiograph) comes under Risk Class B, which requires a MD5 license for manufacturing. The fees for this MD5 license is Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Apexcardiograph (vibrocardiograph)?

Securing a manufacturing license for any medical device, including Apexcardiograph, is essential. It ensures adherence to production quality standards and safeguards patients from substandard products. Regulatory compliance in health industry gains more importance when it comes to devices like Apexcardiographs, which play a critical role in diagnosing and monitoring cardiovascular diseases.

Steps to Obtain a CDSCO Manufacturing License for Apexcardiograph (vibrocardiograph)

The procedure for obtaining a manufacturing license involves several steps and document submissions. These include providing the Device Master File, Quality Management Certificate, device details, site details, etc. More details can be found in this article.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Apexcardiograph as per Medical Device Rules, 2017?
A1. Risk Class for Apexcardiograph (vibrocardiograph) is Class B.

Q2. What license is needed to manufacture Apexcardiograph?
A2. To manufacture Apexcardiograph, an MD5 license is required.

Q3. What is the fee for MD5 license for Apexcardiograph?
A3. The fee for MD5 license is Rs. 5,000 and an additional Rs. 500 per product.

Q4. Who will issue manufacturing license for Apexcardiograph?
A4. For Class B devices like Apexcardiograph, the state FDA will issue the license.

Q5. Is repackaging of Apexcardiograph considered manufacturing?
A5. 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 Apexcardiograph is also considered manufacturing requiring a license on MD5.

Conclusion

Taking into account the complexities involved in obtaining a CDSCO Manufacturing License for medical devices, professional consultation certainly provides a significant advantage. Access expert advice and assistance regarding the licensing process from Pharmadocx Consultants through their website, email, or contacting directly on +91-7404557227.

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