How KeHui Medical Became the Preferred CDMO for Smith & Nephew and Zimmer Biomet Over 29 Years

As a business model that provides customers with integrated services ranging from product design and development to manufacturing, the medical device CDMO sector has matured abroad and established a complete industrial chain. However, for a long period in the past, China’s medical device CDMO industry remained in its nascent stage, awaiting further development.

In 2017, the Marketing Authorization Holder (MAH) system for medical devices was officially implemented in China, laying the institutional foundation for the vigorous promotion of the CDMO model domestically and ushering in new development opportunities for medical device CDMOs.

This system allows holders of medical device registration certificates to conduct research, development, and production by entrusting medical device manufacturers with sound quality management systems. Currently, new entities such as research institutions, universities, hospitals, and scientific researchers have also emerged in the medical device R&D outsourcing industry, and are permitted to develop products through entrusted arrangements.

Since the formal implementation of the Marketing Authorization Holder (MAH) system for medical devices in China, and with the addition of the Medical Device Registrant system in the 2021 revised Regulations on the Supervision and Administration of Medical Devices, this policy combination has provided guidance from the source of the entire industry chain, including R&D, clinical trials, product ownership rights, and manufacturing enterprises. These measures encourage innovation in pharmaceuticals and medical devices, streamline regulatory processes, and accelerate approval speeds, thereby creating new development opportunities for Medical Device Contract Development and Manufacturing Organizations (CDMOs) in China.

With the improvement of China’s policy environment and the growth of market demand, medical device CDMOs are gradually emerging in China and showing a trend toward diversified development.

Zhejiang Canwell Medical Co., Ltd. (hereinafter referred to as “Canwell Medical”), established in 1994, is among the first enterprises in China specializing in the research, development, and production of orthopedic implantable medical devices, orthopedic surgical instruments, and rehabilitation equipment, with a portfolio coveringWith approximately 4,000 product specifications spanning orthopedic trauma, spine, sports medicine, joints, dental implants, and biomedical materials, the company is among the first batch of national “Little Giant” enterprises specializing in refined, distinctive, and innovative products, as well as a National Intellectual Property Advantage Enterprise.

To address the lack of mature domestic suppliers for foreign brands and to meet the needs of multinational enterprises for local production and sales in China, Canwell Medical established a comprehensive production system and equipment infrastructure in line with the high standards of renowned overseas companies from its inception, thereby accumulating extensive experience in contract manufacturing.

Since 2003, the company has provided OEM services to globally renowned orthopedic device manufacturers such as Smith & Nephew and Zimmer Biomet., with product quality and performance indicators meeting advanced international standards, it is the only orthopedic medical device manufacturer in China that started as an OEM supplier for globally renowned companies.

“At that time, the OEM (Original Equipment Manufacturer) collaboration model was widely advocated. Under this model, clients provided drawings and specifications, while Canwell handled production and manufacturing. Initially, the company exclusively provided OEM services to Zimmer Biomet’s Jinhua factory. As the partnership deepened and the company’s influence in international contract manufacturing grew, other industry players such as Smith & Nephew and MicroPort successively sought collaborations with us. Currently, we are the largest OEM service provider in Asia for both Smith & Nephew and Zimmer Biomet, and the Canwell brand ranks among the top three in Asia’s contract manufacturing sector,” said the founder of Canwell Medical.

Having collaborated with foreign-invested enterprises for many years, Canwell Medical has established a comprehensive project transfer process, enabling both parties to complete the transfer in a step-by-step manner according to requirements. Meanwhile, Canwell Medical’s regulatory affairs department regularly monitors changes in domestic and international regulatory policies and organizes training sessions to ensure the company remains fully compliant with current regulations.

In 2015, Shanghai began piloting the Marketing Authorization Holder (MAH) system, opening the door for Contract Development and Manufacturing Organizations (CDMOs). Currently, clients’ expectations of CDMOs have extended upstream in the industry chain, with a greater emphasis on suppliers’ capabilities in design, development, and regulatory registration.

Driven by the Marketing Authorization Holder (MAH) system, the Contract Development and Manufacturing Organization (CDMO) industry has experienced rapid growth, giving rise to numerous outstanding enterprises. In the future, the industry may evolve toward a model in which clients need only propose a product concept, with CDMO companies assuming responsibility for the entire process from design and regulatory registration to manufacturing.

Canwell Medical boasts extensive experience in collaborating with enterprises both domestically and internationally, enabling it to meet a wide range of customer needs. The company is not only capable of providing comprehensive services for contracted product R&D, registration, and contract manufacturing, but also offers tailored solutions such as CDO (Medical Device Design and Development Support), medical technology transfer and commercialization, product registration, regulatory consulting, QMS establishment consulting, CDMO (contract manufacturing services during the market access phase), CMO (batch production management services for marketed products), and localization of overseas projects for domestic production. Its holistic solutions cover the entire process from R&D, product registration, and supply chain management to contract manufacturing.

As CDMOs span multiple industries, cross-disciplinary integration presents a major challenge for medical device CDMOs.

Canwell Medical’s ability to address this challenge stems from its comprehensive portfolio of approximately 4,000 product specifications spanning orthopedic trauma, spine, sports medicine, joints, dental implants, and biomedical materials. This capability is driven not only by the company’s agility in enhancing the rapid learning abilities of its technical staff—through a fast-learning platform built on combined external and internal training, with dedicated departments collecting regulatory requirements to ensure customer needs are met in full compliance with regulations—but also by Canwell Medical’s mature expertise in product development and project management. In summary:

The first isRegistration Capability. Canwell Medical possesses extensive experience in the field of medical device registration. As a pilot enterprise for the Marketing Authorization Holder (MAH) system, the company is able to accelerate the product registration process and shorten time-to-market. Furthermore, the company maintains a professional regulatory affairs team with substantial experience in registering Class II and Class III medical devices, and has established a comprehensive Quality Management System (QMS) to meet stringent registration requirements. The company also provides regulatory consulting services to help clients understand changes and impacts in domestic and international regulatory policies, thereby formulating reasonable registration strategies and solutions for them.

The second isTechnical Team. The company’s technical team comprises engineering and quality resources. The engineering resources encompass experienced process and programming teams, with each engineer capable of independently conducting process development, program development, fixture design, tooling design, mold design and manufacturing, 2D & 3D model analysis, and special process validation. The quality resources include seasoned Quality Engineering (QE) and Quality Control (QC) teams responsible for quality control planning, gauge design, Measurement System Analysis (MSA), Process Capability Index (CPK), Process Failure Mode and Effects Analysis (PFMEA), Statistical Process Control (SPC), Design of Experiments (DOE), and supplier quality management. The company’s technical team provides customers with comprehensive services ranging from product design and development to manufacturing, ensuring product quality and efficiency.

Third,Manufacturing CapabilityThe company owns more than 100 units of high-end precision production equipment, including Swiss Mikron five-axis machining centers and Japanese Citizen Swiss-type lathes, demonstrating strong manufacturing capabilities. Furthermore, the company has established a production quality system compliant with FDA and CE certifications, and through OEM services for internationally renowned orthopedic device companies, it possesses production technologies that meet international brand manufacturing standards. Additionally, the company operates independent workshops providing surface treatment services, including electropolishing, passivation, cleaning, sandblasting, and anodizing. The company is able to provide customized production services based on customers’ product characteristics and requirements, fulfilling orders of varying specifications and quantities.

Fourth,Quality SystemThe company regards product quality as its primary lifeline and has established a rigorous quality management system, obtaining certifications from the U.S. FDA, the EU CE, and ISO 13485. Quality control encompasses incoming material inspection, in-process control, and finished product inspection. The company is specially equipped with precision measuring instruments and testing machines, such as coordinate measuring machines (CMM), profile projectors, OGP 3D video measuring systems, tensile testing machines, fatigue testing machines, and torque testing machines, to ensure that products meet high-quality standards. Additionally, the company provides QMS establishment consulting services to help clients develop QMS processes compliant with domestic and international regulatory requirements.

Finally,Client Collaboration Experience. The Company has established strategic partnerships with multiple internationally renowned companies and undertakes contract manufacturing for products of three globally top-five famous brands, including Smith & Nephew, Zimmer Biomet, and MicroPort. In addition, the Company is also involved in surgical robot projects, military products, and CDMO projects.

In the future, Canwell Medical will continue to uphold its corporate philosophy of “Technological Innovation and Service for the Benefit of Society,” constantly enhance its core competitiveness, strengthen exchanges and cooperation with domestic and international partners, expand market opportunities, and strive to become a globally leading CDMO service provider in the medical device industry, contributing to the development and advancement of the sector.