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Medical Equipment Manufacturing License in India under Medical Device Rule

The Indian Medical Device Industry has witnessed significant growth and transformation over the years, and the demand for Medical Equipment has been on the rise. As a result, medical equipment manufacturing has become a crucial sector contributing to the healthcare ecosystem. However, to ensure the safety, quality, and efficacy of medical equipment, stringent regulations are in place. This article delves into the process of obtaining a Medical Equipment Manufacturing License in India, highlighting the key regulations, steps, and considerations involved.

1. Regulatory Framework for Medical Equipment Manufacturing License

The manufacturing of medical equipment in India is regulated primarily by the Central Drugs Standard Control Organization (CDSCO), which operates under the purview of the Ministry of Health and Family Welfare. The CDSCO enforces the Medical Device Rules, 2017, which outline the requirements for obtaining a license to manufacture medical devices in India.

2. Types of Medical Equipment Manufacturing Licenses

Manufacturers seeking to produce medical equipment in India must obtain either a Manufacturing License or a Registration Certificate, depending on the classification of the medical device. Medical devices are categorized into four classes based on their risk and complexity, ranging from Class A (low risk) to Class D (high risk). Class A and B medical devices are required to obtain MD-5 Manufacturing License, while Class C and D devices necessitate MD-9 Manufacturing License.

3. Steps to Obtain a Medical Equipment Manufacturing License

3.1 Classify the Device

Determine the classification of the medical device according to the risk it poses and the intended use. This classification will determine whether you need MD-5 Manufacturing License or MD-9 Manufacturing License.

3.2 Prepare Documentation

Compile the Device Master File for Medical Devices, which includes information about the device’s specifications, manufacturing process, quality control procedures, and clinical data, Risk Management, Essential Principle Checklist, Device Validation

3.3 Quality Management System (QMS)

Establish a robust Quality Management System in accordance with ISO 13485 or ICMED 13485 Standards. A well-defined QMS demonstrates your commitment to maintaining the quality and safety of your medical devices.

3.4 Submit Application

Submit the application for Medical Device Manufacturing License to the CDSCO along with the required fees and supporting documents through SUGAM Portal.

3.5 Site Inspection

The Licensing Authority will conduct inspections of the manufacturing facility to ensure compliance with regulations. Adequate infrastructure, qualified personnel, and adherence to good manufacturing practices are key factors assessed during the inspection.

In the case of MD-5 Manufacturing License, a Registered Notified Body will conduct the inspection and if you are applying for MD-9 Manufacturing License, a Team from CDSCO will conduct an inspection.

3.6 Review Process

The Licensing Authority will review the application and assesses the submitted documentation. If further information is required, they may raise queries. The manufacturer will address the queries as appropriate.

3.7 Obtain Medical Equipment Manufacturing License

Upon successful review and inspection, the Licensing Authority will issue the appropriate Manufacturing License MD-5 or MD-9, allowing the manufacturers of medical devices to legally manufacture the medical equipment.

4 Fee for Medical Equipment Manufacturing License

For MD-5 Medical Device Manufacturing License for Class A and B Devices, the manufacturer is to pay ₹ 5,000/- for License Fee and ₹ 500/- for each distinctive medical device. For MD-9 Medical Device Manufacturing License for Class C and D Devices, the manufacturer is to pay ₹ 50,000/- for License Fee and ₹ 1,000/- for each distinctive medical device.

5 Validity of Medical Device License

The Medical Device Manufacturing License issued on Form MD-5 & MD-9 will remain valid forever if the manufacturer pays the renewal fee in an interval of five years and unless it is revoked by the Licensing Authority.

6 Considerations and Challenges

While the process of obtaining a license to manufacture medical equipment in India is outlined, there are several considerations and challenges that manufacturers should be aware of:

6.1 Stringent Regulations

The regulatory process is comprehensive and demands adherence to strict quality and safety standards, which may increase the time and resources required.

6.2 Clinical Data Requirements

For certain high-risk medical devices, clinical data demonstrating safety and efficacy may be required, adding to the complexity of the application process.

6.3 Changing Regulatory Landscape

The regulatory landscape for medical devices is continually evolving, and manufacturers must stay updated on any changes that might impact their licensing status.

7. Conclusion

The process of obtaining a license to manufacture medical equipment in India involves navigating a comprehensive regulatory framework aimed at ensuring the safety and efficacy of medical devices. Manufacturers must meticulously adhere to the requirements set forth by the CDSCO and prioritize establishing a robust Quality Management System. While the journey to obtaining a license might be intricate, it is essential for both manufacturers and regulatory authorities to collaborate to ensure that medical equipment produced in India meets the highest standards of quality and safety.

Manufacturing medical devices is a complex journey, where every step matters. At MedDev Experts, we specialize in guiding you through the intricate process of obtaining a medical device manufacturing license in India.

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