Hangzhou Zhengda Medical's Lower Limb Continuous Passive Motion & Automatic Tourniquet System Secure Malaysia MDA Certification

Hangzhou Zhengda Medical Equipment Co., Ltd. ("Hangzhou Zhengda Medical") achieves another milestone in global expansion as its Malaysian partner successfully obtains medical device registration certificates for the Lower Limb Joint Rehabilitation Device and Automatic Tourniquet System from the Medical Device Authority (MDA) of Malaysia.

Ⅰ. Three Decades of Innovation: Building a Professional Medical Brand

As a National High-Tech Enterprise in China, Hangzhou Zhengda Medical has specialized in orthopedic, rehabilitation, and surgical equipment R&D for over 30 years. With ISO 13485 certification and prior approvals from the EU CE and US FDA, the company continues to expand its global footprint.

Key Products Registered in Malaysia:

1. Lower Limb Joint Rehabilitation Device Applications: Postoperative rehabilitation for hip, knee, and ankle dysfunction.

Features:

Smart touchscreen control system

High-precision sensor technology

Modular design supported by 26 precision molds

Ergonomic support structure for clinical efficacy

2.Electric Pneumatic Tourniquet System Applications: Hemostasis in limb surgeries.

Automatic tourniquet system suitable for hemostasis in orthopedic limb surgery. The product adopts a full touch screen display and control system with good intelligent functions. It has high-end technical functions such as system fault self-check, pressure calibration, LOP, etc. The system pressure accuracy of the product can reach ±5mmHg, and it has clinical functions such as fast and slow deflation. The replaceable built-in lithium battery, combined with the low CPU power consumption system, can meet the clinical surgery needs of more than 10 hours.

Ⅱ. Navigating Strict Regulations: A Collaborative Triumph

Malaysia’s rigorous medical device registration process was overcome through:

1. Multilingual Precision

Professionally translated technical documents in Bahasa Malaysia to comply with local requirements.

2. Full Compliance with Malaysian Regulations

Tailored technical files, including:Malaysia-specific product testing reports, Customized regulatory documentation.Adaptation of ISO 13485 QMS to align with Malaysian standards.

Ⅲ. Market Potential & Future Partnerships

As an important medical market in Southeast Asia and a major transportation hub in East Asia and West Asia, Malaysia has a growing demand for high-quality medical devices. The successful registration not only brings more quality options to local medical institutions, but also opens up another channel for Hangzhou Zhengda to further expand into the international market.

In the future, Hangzhou Zhengda will work together with its partners to continue to increase investment in research and development, launch more innovative products, and contribute the collective wisdom and solutions of its partners to the development of the global medical industry.