Zhongya Medical Successfully Obtains ISO 13485 Certification, Elevating Dental Implant Quality Control to a New Level
Recently, Zhongya Medical, a company dedicated to the R&D and production of dental implants and supporting accessories, officially announced that it successfully passed the ISO 13485 Medical Device Quality Management System certification in May 2025. This marks that the company has reached international standards in full-life-cycle product quality control and compliance management, laying a solid foundation for expanding domestic and overseas markets.
Zhongya Medical has deeply rooted itself in the dental implant sector, with core businesses covering the R&D, production and sales of various dental implants as well as supporting accessories like abutments and healing caps. It has always adhered to the core philosophy of "ensuring oral medical safety and improving the quality of diagnosis and treatment services". The acquisition of ISO 13485 certification went through multiple rigorous procedures including system establishment, internal audit, management review and on-site audit by the certification body. Eventually, the company successfully passed all audit stages by virtue of its sound quality management system, standardized production process control and robust risk management mechanism.
As an internationally recognized authoritative quality management standard in the medical device industry, ISO 13485 is specially designed for the full life cycle of medical devices. It covers the entire processes of product design and development, production and manufacturing, storage and circulation, installation and service, as well as final decommissioning and disposal. It focuses on strengthening regulatory compliance and product safety risk management, serving as a "passport" for enterprises to enter mainstream international medical device markets such as the EU and the United States. For implantable medical devices such as dental implants, passing this certification means Zhongya Medical’s product quality and management standards have gained international recognition, enabling it to provide more reliable safety guarantees for clinical applications.
The relevant person in charge of Zhongya Medical stated that the successful acquisition of ISO 13485 certification is an important milestone in the company’s development. Going forward, taking this certification as a catalyst, the company will continuously deepen the effective operation of its quality management system, strictly control all links including R&D, production and inspection in accordance with international standards, and constantly improve the safety and stability of its products. Meanwhile, leveraging the international market recognition brought by the certification, it will actively expand domestic and overseas business channels, promote domestic dental implant products to broader markets, and contribute to the high-quality development of the oral medical industry.
Insiders pointed out that with the enhancement of residents’ awareness of oral health, the demand for dental implants keeps growing, and the industry’s requirements for product quality and compliance are becoming increasingly stringent. The popularization of ISO 13485 certification will accelerate industry reshuffle and drive high-quality enterprises to stand out. Zhongya Medical’s passing of this certification not only demonstrates its core competitiveness, but also sets a benchmark for the standardized development of small and medium-sized enterprises in the industry.
