ter six months of rigorous evaluation, NEST’s self-developed Disposable Pen Injector has officially received a Medical Device Licence (MDL) from Health Canada.

Licence Number: 113733

This achievement marks another significant milestone in NEST’s global expansion journey.

For customers using NEST products

Quality assurance – The MDL confirms compliance with Canada’s safety and quality standards, strengthening trust among consumers and healthcare institutions.

Global recognition – Canada’s stringent regulatory framework gives the MDL high international credibility, facilitating entry into additional markets.

Regulatory compliance – The licence guarantees adherence to Canadian regulations, preventing fines or market withdrawal due to non-compliance.

For NEST

The MDL further expands our global market reach, elevates the NEST brand, and boosts competitiveness.

Throughout the MDL application, NEST continuously refined product design and manufacturing processes, driving technological innovation and quality improvement.

Ongoing dialogue with Health Canada provided valuable feedback, enabling additional product enhancements.

NEST Pen Injector Portfolio

As demands increase for higher-quality drug-delivery systems, pharmaceutical packaging, and combination products, NEST obtained its medical-device manufacturing licence in 2021. The portfolio now includes:

• Disposable pen injectors

• SP pen-injector assemblies

• Disposable fixed-dose pens

• Reusable pen injectors

• Prefilled pen injectors

• Twist-in pen injectors

These devices are compatible with medications such as semaglutide, FSH, liraglutide, insulin, growth hormone, and more.

Accelerating Globalization of Made-in-China Drug Delivery Devices

From R&D to production and commercialization, Chinese drug packaging products are rapidly gaining global presence.

NEST’s pen injector series has achieved:

✅ U.S. FDA 510(k) clearance

– Disposable pen injector: 510(k) No. K240961

– Reusable pen injector: 510(k) No. K240774

✅ Freedom-to-Operate (FTO) assessments completed in both China and the U.S., ensuring no patent infringement risk.

✅ MDSAP certification (Medical Device Single Audit Program)

✅ Health Canada Medical Device Licence (MDL)

✅ U.S. FDA Type III Drug Master File (DMF) submission completed – DMF No.: 40744

Fast-Track Customization Now Available!

NEST’s custom pen injector solutions are now open for fast-track service.

Follow the official WeChat account “WUXI NEST”

→ Click the menu “Inquiry & Feedback”

→ Select “Pen Injector Customization”

→ Submit your customization request now!

https://pharmapack.nestscientificusa.com/customisation