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CDSCO Manufacturing License for Dry-heat sterilizer.

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Introduction

The Central Drugs Standard Control Organization (CDSCO), the principal regulatory body governing the production and distribution of drugs and medical devices in India, carries a significant responsibility in fostering public health. CDSCO plays a pivotal role in ensuring the safety, quality, and efficacy of medical products marketed and distributed across the country, having a far-reaching impact on the medical device industry.

An essential aspect of the CDSCO's regulatory mechanism is its oversight of manufacturing licenses. These licenses ascertain the adherence of manufacturers to quality standards and specifications, thereby protecting patient health and safety.

Among countless medical devices within the purview of the CDSCO are Dry-heat sterilizers. These sterilizers, intended for use by healthcare providers to sterilize medical devices using dry heat, are a critical component of healthcare delivery. Sterilization of medical devices directly contributes to patient safety, rendering a sterilizer key to medical procedures.

To learn more about the CDSCO and its regulatory practices, follow this link to the CDSCO's portal CDSCO's Online Portal.

What is a Dry-heat Sterilizer?

A Dry-heat sterilizer is a medical device used by healthcare providers to sterilize medical instruments and equipment. It uses dry heat to kill bacteria and other pathogens on medical devices, ensuring that they are safe for use on or in patients.

These sterilizers are commonly used in hospitals, clinics, and other healthcare settings. They are essential for procedures that require sterile equipment, such as surgeries, and aid in preventing the spread of infections.

The Role of CDSCO in Medical Device Regulation

With its inception, the CDSCO has been on a mission to safeguard public health in India. It oversees the quality of drugs and medical devices that reach consumers, applying a robust regulatory framework for medical devices.

This framework includes classifying medical devices based on risk, assessing the quality of these devices, and issuing necessary licenses to manufacture them. Standards and stringent procedures dictated by the CDSCO ensure the production of safe, reliable, and effective devices, including the Dry-heat sterilizer.

How to Manufacture a Dry-Heat Sterilizer

Fees for Manufacturing License for a Dry-Heat Sterilizer

For the manufacture of a Dry-Heat Sterilizer, classified as Class C medical device, an MD9 license is required. The fee for an MD9 license is Rs.50,000 for the license and an additional fee of Rs.1,000 per product.

Why is a Manufacturing License Necessary for a Dry-Heat Sterilizer?

Getting a license is not just a regulatory formality. It is an integral part of ensuring quality and safety in the production of medical devices. Regulatory compliance is vital in the healthcare sector. It helps manufacturers and marketers adhere to international quality standards, protect consumers, and prevent the circulation of sub-standard products.

Steps to Obtain a CDSCO Manufacturing License for a Dry-Heat Sterilizer

To obtain a manufacturing license for a Dry-Heat Sterilizer, the manufacturer needs to submit various documents including the Device Master File, Quality Management Certificate, Device Details, and Site details, to name a few.

The application process carries from submission to approval in four broad phases: Pre-submission consultation, review and evaluation, decision-making, and post-authorization activities. Each of these stages requires meticulous attention to detail and timely follow-ups.

Frequently Asked Questions (FAQs)

Q1. What is risk class of a Dry-Heat Sterilizer as per Medical Device Rules, 2017?
A1. A Dry-Heat Sterilizer falls under Risk Class C.

Q2. What license is needed to manufacture a Dry-Heat Sterilizer?
A2. An MD9 license is required to manufacture a Dry-Heat Sterilizer.

Q3. What is the fee for the MD9 license for a Dry-Heat Sterilizer?
A3. The fee for an MD9 license is Rs.50,000 for the license and an additional fee of Rs.1,000 per product.

Q4. Who will issue manufacturing license for a Dry-Heat Sterilizer?
A4. For Class C devices like Dry-Heat Sterilizer, CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of a Dry-Heat Sterilizer considered manufacturing?
A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since the Medical Device Rules have been made under the provisions of the Drug Act, repackaging of a Dry-Heat Sterilizer is also considered manufacturing, requiring an MD9 license.

For an extensive guide on how to obtain an MD9 license, we commend this article that provides elucidating details - Link to Article

Conclusion

Understanding regulatory compliance and obtaining necessary licenses can be challenging. Therefore, we encourage readers to reach out to Pharmadocx Consultants for consultation or assistance regarding the licensing process. You can visit their website at Pharmadocx Consultants, reach them via their helpline "+91-7404557227" or write to them at "[email protected]".

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