2025-02-08
New Year Greetings | Pen Injector Obtains Medical Device Licence in Canada!

On January 30, 2025, coinciding with the Chinese Lunar New Year, on this day of nationwide celebration, Nest Life also received the first good news of the Year of the Snake. 


The disposable pen injector independently developed by Nest


successfully passed the Medical Device License (MDL) from the Canadian Ministry of Health once again!

Licence Number: 112619



This is another milestone achievement for NEST!


▶For customers using NEST-related products:

1.Quality Recognition: The MDL indicates that the product meets Canada’s safety and quality standards, enhancing trust among consumers and medical institutions.

2.International Recognition: Canada’s strict regulations on medical devices give the MDL high international recognition, facilitating entry into other markets.

3.MDL ensures the product complies with Canadian regulations, preventing fines or bans due to non-compliance.


▶For NEST:

1.After obtaining the MDL, the sales range of the product in global markets has been further expanded, enhancing the NEST brand image and increasing market competitiveness.

2.During the MDL application process, NEST continuously optimized product design and manufacturing processes, driving product technological innovation and quality improvement.

3.Through communication with the Canadian Ministry of Health, NEST also received valuable feedback on the product, which helped NEST further improve the product.


NEST Pen Injector

With the development of the times, the quality requirements for drug delivery systems, drug packaging, and combination products have been continuously improving. NEST obtained its Medical Device Manufacturing License in 2021 and has since developed a product lineup including disposable pen injector components, SP pen injector components, disposable fixed-dose pen injectors, reusable pen injectors, and pre-filled pen injectors. These products are designed to accommodate drugs such as semaglutide, follicle-stimulating hormone (FSH), liraglutide, insulin, growth hormone, and more.




In recent years, the momentum of domestic drug packaging materials going global has been rapid and continues to grow. From R&D and manufacturing to commercialization, 'Made in China' is accelerating its entry onto the international stage.


1.NEST’s disposable pen injector and reusable pen injector have both successfully obtained U.S. FDA 510(k) certification! They have also completed FTO (Freedom to Operate) reviews in both China and the U.S., ensuring no patent risks! 

(Disposable pen-style syringe 510(k) Number: K240961)

(Reusable pen-style syringe 510(k) Number: K240774)


2.Successfully passed the Medical Device Single Audit Program (MDSAP) certification!

3.Completed the FDA Drug Master File (DMF) Class III registration! (DMF Number: 40744)


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Wuxi NEST Biotechnology Co., Ltd.

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CONTACT US 

TEL:0510-6800 6788

E-mail:info@nest-wuxi.com

Web:www.cell-nest.com