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origin：Hangzhou Zhengda Medical Co., Ltd. Time：2025-7-8 Hits：379
Recently, Hangzhou Zhengda Medical Equipment Co., Ltd. (hereinafter referred to as "Hangzhou Zhengda") has once again achieved the results of international cooperation - our Malaysian partner has successfully obtained the Malaysian medical device registration certificate for the lower limb joint rehabilitation device and electric pneumatic hemostatic device. This marks that Hangzhou Zhengda's internationalization strategy continues to make gratifying progress.
1. Hangzhou Zhengda focuses on research and development to create a professional medical device brand
Since its establishment, Hangzhou Zhengda Medical Equipment Co., Ltd. has always focused on the research and development and manufacturing of orthopedic, rehabilitation and surgical equipment. As a specialized and new small and medium-sized enterprise in Zhejiang Province, the company has a complete technology research and development, production and quality management system. Many of the company's products have passed the ISO 13485 international medical device quality management system certification. After obtaining the EU CE and US FDA certification for many products, partners in many countries around the world have also carried out product registration in local countries.
The two products successfully registered in Malaysia this time are Hangzhou Zhengda's most competitive products, including the following features:
① Lower limb joint rehabilitation device: suitable for rehabilitation treatment of patients with lower limb joint dysfunction such as orthopedic hip, knee, ankle, etc. The product adopts a full touch intelligent control system, high-precision sensor control technology, and three-dimensional support rods that meet the needs of clinical treatment. The product uses 26 sets of molds and has an excellent level of large-scale manufacturing.
②Electric pneumatic hemostat: 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.
2. Work together to overcome registration difficulties and demonstrate professional strength
Malaysia's medical device registration process is known for its strictness. Hangzhou Zhengda worked together with local partners to overcome multiple challenges:
① Accurately overcome language barriers
Faced with the Malay documents required by the Malaysian government, the customer team communicated and coordinated closely with Hangzhou Zhengda Medical Devices Co., Ltd., and under the translation of the professional medical team, ensured that all technical documents, system documents and registration materials were translated accurately, laying the foundation for smooth registration.
② Comprehensive research and compliance with local national regulations
The two teams conducted in-depth research on Malaysian medical device regulations and carefully prepared the following:
Complete local medical device industry and product regulatory documents;
Product technical documents that need to be prepared according to local country regulations;
Product test reports with local characteristics that need to be prepared according to local country requirements.
③ Quality management system documents with local country characteristics
The medical device product production system of each country has certain local national characteristics. The two teams worked closely together, conducted serious research, and combined with reality, and finally successfully completed the construction of the ISO13485 system that meets the requirements of Malaysian national regulations.
3. Broad market prospects and promising future cooperation
As an important medical market in Southeast Asia and a major transportation route between East Asia and West Asia, Malaysia has a growing demand for high-quality medical devices. The successful registration not only brings more high-quality choices 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.
