In the medical technology industry, quality and compliance are the foundation on which a company stands, and innovation and honors are the proof of real strength. As a company focused on the research and manufacture of medical technology, Hubei Kangquan Medical Technology Co., Ltd. (“Kangquan Medical”) has always treated product quality and its management system as the lifeline of its development. Over the years, Kangquan Medical has won authoritative recognition in China for technological innovation. With a global outlook, it has also moved faster on its international strategy, aligned itself with the highest international quality standards, and steadily built market access and compliance that reaches worldwide.

1. Driven by innovation: national and provincial honors

Kangquan Medical knows that innovation is the first driving force of development. With solid research strength and continued investment in innovation, the company has been recognized many times by national and provincial authorities, moving from a technology-based enterprise to a high-tech enterprise, and then to a specialized and sophisticated SME.

2022: Two honors in one year. The company was named a Technology-based SME and, in the same year, an Innovative SME of Hubei Province. This showed that its technological innovation and product development had taken shape and received official recognition.

2023: Named a National High-tech Enterprise (certificate No. GR202342000723). This was not the first time. In 2020, Kangquan Medical already held high-tech enterprise certificate No. GR202042003185. Remaining a national high-tech enterprise across these years shows the company’s technical depth and continued ability to innovate.

2024: Specialized and sophisticated, a further step. The company was selected into the sixth batch of Specialized and Sophisticated SMEs of Hubei Province. This means Kangquan Medical has made important progress in specialization, refinement, distinctiveness, and novelty, and stands among the leaders in its market segment.

2. Built on quality: international and domestic certification

Kangquan Medical has always put quality first. It has built a complete quality management system and kept pace with international regulations.

ISO 13485. As early as 2019, the company obtained ISO 13485 certification for medical-device quality management systems. This internationally used certification supports the stability and reliability of its product quality.

CE. In 2019, Kangquan Medical obtained the MDD CE certificate, with coverage through 2024. As the European Union moved fully to the Medical Device Regulation (MDR), the company planned ahead and obtained the MDR CE certificate in 2026. This means its product quality and system management meet the European Union’s latest and strictest regulatory requirements.

3. Compliance first: domestic registration and production licenses

In China, the company holds a Class II medical device production license and has obtained several Class II medical device registration certificates. On the basis of these domestic registration and production licenses, the corresponding Free Sale Certificates (FSC) have been approved by the National Medical Products Administration. This closed loop shows that Kangquan Medical’s products meet the strict supervision of the national authority, and it gives overseas customers an official basis for trust when the products are exported.

4. Working together: inviting partners worldwide

With complete qualifications, a strict quality system, and sufficient capacity, Kangquan Medical is open to cooperation worldwide. We sincerely invite distributors in China and abroad, and we undertake contract manufacturing and registrant cooperation, so as to support partners across the medical industry.

Distributors in China and abroad. We supply high-quality medical products covered by MDR CE, domestic registration certificates, and FSC. This set of qualifications lets distributors promote the products at home and abroad with less compliance concern, and develop the market together with us.

OEM/ODM manufacturing. Under the ISO 13485 quality system and the Class II medical device production license, we have a professional production team and strict quality control, and can provide stable, efficient, and compliant custom manufacturing.

Registrant (MAH) cooperation. Kangquan Medical has registration experience at home and abroad and a mature compliance system. Partners are welcome to use our platform for registrant cooperation, so that products can obtain market authorization in a faster and compliant way.

In closing

From a technology-based SME in 2020, to a National High-tech Enterprise in 2023, and a provincial specialized and sophisticated enterprise in 2024; from ISO 13485 in 2019 to the MDR CE certificate in 2026 — behind each date and each certificate is Kangquan Medical’s commitment to quality first and compliant operation.

In the future, Hubei Kangquan Medical Technology Co., Ltd. will continue to take these honors as a spur, and its international and domestic certification system as the foundation. We will keep raising our research strength and quality management, and provide safer, more efficient, and higher-quality medical devices and services to healthcare institutions and patients around the world.