On April 20, 2026, the NEST self-developed TSA disposable pen injector was granted a Class II medical device registration certificate (Jiangsu Approval No. 20262140629).

To date, NEST has obtained Class II certification for four products: pen injectors, disposable pen injectors, and single-use nasal drug delivery devices.

This marks another important milestone for NEST.

▶ For customers using NEST products:

1. Quality assurance:

The Class II medical device registration confirms that NEST pen injectors comply with NMPA regulations and technical requirements, demonstrating their safety and effectiveness, and enhancing customer confidence.

2. Clinical compliance:

Certification allows the product to be legally used in clinical and research settings, helping customers avoid compliance risks in procurement and use.

3. Improved market access:

With full regulatory approval, the product can enter a wider range of hospitals, research institutions, and medical channels, ensuring a more stable and reliable supply.

▶ For NEST:

1. Enhanced brand and competitiveness:

The certification not only enables market entry in China but also strengthens NEST’s brand image and competitiveness globally.

2. Driven innovation and quality improvement:

The registration process helped optimize product design, manufacturing, and quality management in line with national standards.

3. Strategic growth support:

This achievement lays a solid foundation for domestic expansion and supports future international market development.

As expectations for drug delivery systems, pharmaceutical packaging, and combination products continue to rise, NEST pen injectors are well positioned to meet evolving demands.

NEST obtained its Medical Device Manufacturing License in 2021 and has since developed a comprehensive product portfolio, including disposable pen injectors, SP pen injector assemblies, fixed-dose disposable pens, reusable pen injectors, prefilled pen injectors, and screw-type pen injectors. These products are compatible with drugs such as semaglutide, FSH, liraglutide, insulin, and growth hormone.

In recent years, Chinese pharmaceutical packaging has accelerated its global expansion. From R&D to commercialization, “Made in China” continues to gain international presence.

Key achievements:

1. Disposable, reusable, and TSA pen injectors have obtained US FDA 510(k) clearance and passed FTO reviews with no patent risks.

2. Multiple products, including pen injectors and nasal drug delivery devices, have received Class II medical device certification in China.

3. Pen injector assemblies and related products are certified under MDSAP and MDL.

4. Pen injector assemblies are listed under FDA DMF Type III.

5. NEST reusable pen injectors are certified under EU MDR.