At NEST, we are dedicated to providing safe, clean, and high-quality pharmaceutical packaging and medical devices. Our global supply chain, combined with our ability to offer customizable services, enables us to meet the diverse and dynamic needs of the healthcare industry worldwide. With each achievement, we continue to push the boundaries of innovation. Below is a detailed timeline of our recent milestones that reflect our commitment to excellence and the future of medical device technology.
1. September 21, 2024: NEST Pen Injector Exports to the U.S. Market – A Major Leap Forward
On September 21, 2024, NEST proudly launched our Pen Injector in the U.S. market. This momentous occasion marked a significant step in our global expansion, bringing our cutting-edge medical device to one of the largest healthcare markets in the world. The Pen Injector is a user-friendly device that combines both medication and injector into one seamless system. Patients no longer need to manually extract medicine from a vial; instead, they can easily adjust the dose and inject, making it a more convenient and safe solution for chronic condition management.
This strategic move to export the Pen Injector to the U.S. was just the beginning. With the U.S. market known for its stringent regulatory standards, this launch solidified NEST’s reputation as a trusted global partner in the healthcare industry. Our Pen Injector ensures accuracy, ease of use, and patient comfort, positioning us to serve not just the U.S., but also future international markets with the same level of dedication and innovation.
2. August 16, 2024: NEST Pen Injector Achieves FDA 510(k) Clearance – A Historic Milestone
Just one month earlier, on August 16, 2024, NEST achieved a historic milestone with the FDA 510(k) clearance for our Reusable Pen Injector (K number: K240961). This FDA approval marked a groundbreaking achievement for NEST as we became the first company from China to receive FDA clearance for a pen injector. The FDA 510(k) clearance process is rigorous and ensures that devices meet the highest standards for safety, efficacy, and quality.
This accomplishment was followed shortly by the receipt of an FDA 510(k) letter for our Disposable Pen Injector, further solidifying our commitment to innovation and regulatory compliance. The clearance not only opens the door for NEST to expand in the U.S. market but also sets the stage for future growth in other regulated regions. With FDA 510(k) clearance, healthcare providers can trust that our Pen Injector delivers precise dosing with a focus on patient safety.
NEST’s focus on quality and compliance is evident in this achievement. We are committed to maintaining high standards while developing medical devices that enhance the patient experience and improve healthcare outcomes. Our Pen Injector is part of a growing portfolio of devices that aim to meet the diverse needs of patients and healthcare professionals alike.
3. November 14, 2024: NEST Nasal Device Receives FDA DMF Certification
In November 14, 2024, NEST achieved another key milestone when our Nasal Device received FDA Drug Master File (DMF) certification. The DMF certification is a critical step in the regulatory process for drug delivery systems, ensuring that our Nasal Device complies with the FDA’s strict standards for safety, performance, and quality. This device is designed for efficient and precise medication delivery, allowing patients to take medications in a way that’s more comfortable and accessible.
Disposable Intranasal Atomization Device (DMF Number: 38260)
Disposable Pre-filled Spray Device (DMF Number: 40629)
The FDA DMF certification not only validates our technology but also enhances our reputation as a company that develops and manufactures products with uncompromising quality. The certification makes the Nasal Device eligible for integration into various pharmaceutical formulations, further expanding NEST’s role in the global healthcare market. Our Nasal Device will now be an essential tool for healthcare professionals, ensuring safe, effective, and reliable medication delivery.
As a company, NEST remains deeply committed to advancing drug delivery technologies. The Nasal Device stands as a testament to our focus on developing medical products that meet real-world healthcare needs and improve patient outcomes. This milestone is a proud example of how we strive for innovation in every aspect of our product development.
4. November 27, 2024: NEST Pen Injector Achieves MDSAP Certification – A Global Recognition of Quality
Finally, on November 27, 2024, NEST’s Pen Injector received the highly regarded Medical Device Single Audit Program (MDSAP) certification. The MDSAP program, based on ISO 13485, is an international certification that ensures compliance with the regulatory requirements of five major markets: the U.S., Canada, Brazil, Australia, and Japan. This certification streamlines the auditing process, reducing regulatory burdens and ensuring faster access to international markets.
Achieving MDSAP certification represents NEST’s dedication to global quality standards. The recognition not only affirms that our Pen Injector meets international safety and performance standards but also enhances our ability to serve markets around the world more efficiently. With this certification, NEST is able to provide reliable, high-quality medical devices to a wider range of customers, ensuring that healthcare providers worldwide can access safe, effective tools for patient care.
The MDSAP certification also positions NEST as a leader in the global medical device industry, reinforcing our commitment to continuous improvement, patient safety, and regulatory compliance.
NEST: Your Trusted Partner in Global Medical Device Innovation
From FDA 510(k) clearance to MDSAP certification and FDA DMF approval, NEST has proven its ability to meet the highest standards in the medical device industry. These milestones represent not only our technical achievements but also our commitment to enhancing patient care globally.
At NEST, we pride ourselves on developing products that address the diverse and evolving needs of the healthcare industry. We offer a growing portfolio of medical devices, including:
NEST Pen Injector: Combining medication and injector into one device, the Pen Injector is ideal for managing chronic conditions. It ensures accurate dosing, patient comfort, and ease of use, making it a top choice for healthcare providers and patients worldwide.
NEST Nasal Device: Designed for efficient drug delivery, the Nasal Device allows for precise and reliable administration of medications. Its FDA DMF certification highlights our commitment to safety and efficacy, making it a trusted choice for healthcare professionals.
As we continue to expand and innovate, NEST is committed to delivering high-quality medical devices and customized solutions that meet the unique needs of our customers. Our global supply chain ensures that we can deliver these solutions quickly and effectively, no matter where in the world you are.
Stay connected with NEST as we continue to innovate and drive progress in the medical device field. Discover how our global supply chain, cutting-edge technology, and tailored services can support your medical and pharmaceutical packaging needs.
