尊龙凯时·(中国区)人生就是搏!

In today's highly competitive global medical market, obtaining overseas certifications for medical devices presents significant challenges. 

Recently, Hangzhou Zhengda Medical Equipment Co., Ltd. achieved a breakthrough as its self-developed Electric Pneumatic Tourniquet System successfully 

obtained Thailand FDA (TFDA) Medical Device Certification. This accomplishment not only marks a pivotal step in the company's international 

expansion but also underscores its leadership in medical device innovation.

1. Product Excellence: The Foundation for Certification

The certified Electric Tourniquet System is one of Zhengda's flagship products. Designed to meet critical clinical needs, it features:

✔ Precision pressure control

✔ Reliable hemostasis performance for surgical procedures

✔ User-friendly operation, widely recognized by medical institutions globally

2. Overcoming Registration Challenges

Thailand's medical device registration process is rigorous, requiring comprehensive reviews of technical documentation, clinical data, and quality management systems. Zhengda's team navigated three major hurdles:Regulatory differences: Adapted technical files to comply with TFDA requirements, distinct from EU/US standards.

Language barriers: Ensured accurate Thai translations for specialized terminology.

Extended review timelines: Meticulously addressed every detail to avoid delays.

Leveraging deep regulatory expertise, cross-cultural collaboration, and unwavering commitment to quality, Zhengda successfully secured the certification—a testament to its capabilities in global market access.

3. Strategic Impact

This certification authorizes Zhengda's Electric Tourniquet System for legal distribution and use in Thailand, delivering advanced solutions to 

the local healthcare sector. Moving forward, Zhengda remains dedicated to:

🔹 Streamlining global certifications for medical devices

🔹 Enhancing surgical safety worldwide

🔹 Empowering innovations to reach international markets