Certifications & Licenses
Galaxy Innovations
At Galaxy Innovations, we uphold the highest standards of quality, safety, and regulatory compliance. As a Made in India company, we are committed to ensuring that our products are manufactured with the utmost precision and in full alignment with global standards.
We operate with a clear focus on meeting and exceeding the regulatory requirements of the regions in which we operate, ensuring that our products are safe, reliable, and of the highest quality. Our stringent adherence to these standards has earned us certifications and approvals from leading international regulatory bodies, cementing our position as a trusted manufacturer of medical devices.
Certifications & Licence
Form MD-5 | CDSCO, Government of India
Medical Device Manufacturing Licence
This licence is issued to Galaxy Innovations, located at:
E-84, Sector-A7, Tronica City Industrial Area, Loni, Ghaziabad – 201102, Uttar Pradesh, India.
Galaxy Innovations holds a valid Form MD-5 licence issued by the Central Drugs Standard Control Organisation (CDSCO), Government of India, authorizing the manufacture and sale of Class A and Class B medical devices.
This licence confirms that our manufacturing facility at Tronica City Industrial Area, Ghaziabad, Uttar Pradesh meets the regulatory requirements of the Medical Devices Rules, 2017. It reflects our commitment to compliant manufacturing practices, quality control, and patient safety.
With this approval, Galaxy Innovations is authorized to manufacture and distribute medical devices in line with Indian regulatory standards, ensuring safe, reliable, and compliant products for healthcare applications.
Free Sale Certificate (FSC)
Issued by CDSCO, Government of India
This certificate is awarded to Galaxy Innovations, located at:
E-84, Sector-A7, Tronica City Industrial Area, Loni, Ghaziabad – 201102, Uttar Pradesh, India.
Galaxy Innovations holds a Free Sale Certificate (FSC) issued by the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India.
This certificate confirms that our medical devices, manufactured under a valid CDSCO manufacturing licence, are legally approved for sale in the Indian market and are eligible for export in accordance with applicable regulatory requirements. The FSC serves as official regulatory clearance, assuring international buyers and authorities that our products comply with Indian medical device regulations and meet the standards required for global distribution.
ISO 13485:2016
Medical Device - Quality Management System
This certificate is awarded to Galaxy Innovations, located at:
E-84, Sector-A7, Tronica City Industrial Area, Loni, Ghaziabad – 201102, Uttar Pradesh, India.
It certifies that the company is operating a Medical Device Quality Management System that complies with the requirements of ISO 13485:2016.
ISO 13485:2016 is a globally recognized certification specific to the medical device industry. It ensures that we maintain a quality management system that meets the regulatory requirements for the medical devices covering all aspects from design to development to manufacturing and distribution. This certification assures customers that the orthopedic and surgical instruments are produced in compliance with safety and regulatory standards, ensuring their safety, efficacy, and reliability. ISO 13485 also helps us to stay aligned with the changing medical device regulations worldwide, particularly for the products that are used in critical healthcare applications.
ISO 9001:2015
Medical Device - Quality Management System
This certificate is awarded to Galaxy Innovations, located at:
E-84, Sector-A7, Tronica City Industrial Area, Loni, Ghaziabad – 201102, Uttar Pradesh, India.
It certifies that the company is operating a Medical Device Quality Management System that complies with the requirements of ISO 9001:2015.
ISO 9001:2015 is the global benchmark for Quality Management Systems (QMS). Achieving
this certification demonstrates that Galaxy Innovations maintains effective processes for quality management across every stage, from product design to manufacturing. It reflects our commitment to continuous improvement, operational efficiency, and customer satisfaction. This certification validates our ability to consistently deliver medical devices that meet the highest standards of quality and reliability.
These certifications are not just pieces of paper - they represent our ongoing commitment to excellence and our responsibility to deliver only the best to the healthcare industry. Each certification assures our partners and customers that every product manufactured by Galaxy Innovations adheres to the most rigorous regulatory standards, ensuring quality and safety in every step of the process.
Why Certifications Matter
Our certifications go beyond simple marks of compliance – they reflect our steadfast dedication to excellence, safety, and innovation in the manufacturing of medical equipment.
Quality Assurance
We adhere to rigorous industry standards to ensure the highest level of quality in every product. Our certifications guarantee that every device is built with the utmost precision and reliability.
Patient Safety
We prioritize the safety of both patients and healthcare professionals. Our certifications affirm that all our products are designed, tested, and refined to meet the most demanding safety criteria.
Regulatory Compliance
As part of our commitment to integrity, we follow international regulations to ensure that our products meet the legal and ethical standards necessary for global healthcare markets.
Continuous Improvement
Certifications serve as a commitment to continuous improvement. They represent our drive to stay ahead of industry trends, implement cutting-edge technology, and provide the best medical solutions available.
Uncompromising Quality.
Unmatched Trust.
We continuously invest in improving our processes, ensuring that we meet the most stringent industry regulations and keep pace with the evolving needs of global healthcare. Our certifications are a testament to our unwavering dedication to producing medical devices that meet the highest standards of safety, efficacy, and quality.
Our Quality Assurance Process
We follow a rigorous and systematic approach to uphold and exceed certification standards throughout every stage of our production process.
Documentation & Training
Meticulous documentation is maintained at every phase of production, ensuring consistent processes. Additionally, our team undergoes comprehensive training programs to guarantee that every employee is equipped with the knowledge and skills to meet and surpass industry standards.
Continuous Monitoring & Auditing
Ongoing monitoring ensures that each product is in full compliance with safety regulations. Internal and external audits are regularly conducted to maintain accountability and assess areas for improvement.
Testing & Validation
Each product undergoes extensive testing in controlled environments to validate its performance and safety. This step is critical to ensuring that our products meet the highest quality benchmarks before reaching the market.
Feedback Loop & Improvement
We actively collect feedback from both end-users and healthcare professionals to refine our products. Continuous improvement is central to our process, allowing us to evolve with the latest technologies and industry advancements.
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