Medical Device Quality Management System Certification

The medical device quality management system certification is based on ISO13485 Medical devices - Quality management systems - Requirements for regulatory purposes, which was developed by the International Standardization Organization Technical Committee (ISO/TC210). This standard has been widely implemented and applied worldwide since its publication in 1996.

In 2015, ISO/TC210 conducted the third revision of the ISO13485 standard and officially released it in March 2016. Based on ISO 9001:2008, the ISO 13485: 2016 version takes into account the features of the medical device industry, and can be independently used as a quality management system for the medical device industry. This management standard for regulatory environments is also a quality management system requirement for regulatory environments. Different from general listed products in terms of commercial operation environment internationally, medical devices are also subject to supervision and management by national and regional laws and regulations, such as the FDA in the United States, the European Union Medical Device Directive (MDD), and the Regulations on the Supervision and Administration of Medical Devices in China. Therefore, this standard must be subject to legal constraints, operated in a regulatory environment, and fully consider the risks of medical device products, requiring risk management throughout the entire implementation process of medical device products.

On January 19, 2017, China equivalently adopted and transformed this standard into YY/T0287-2017 Medical devices - Quality management systems - Requirements for regulatory (ministerial standard). On October 12, 2022, this standard was upgraded to the national standard GB/T42061:2022 Medical devices - Quality management systems - Requirements for regulatory, which was officially implemented on November 1, 2023.

Certification/Evaluation Standard

GB/T42061:2022 idt ISO13485:2016

Significance of Certification

- Improve the management level of enterprises, avoid legal risks, and increase the visibility of enterprises

- Optimize and ensure the quality of products, and enhance their competitiveness to enable enterprises to achieve greater economic benefits;

- Effectively reduce the risk of product quality accidents or adverse events through effective risk management;

- Help remove trade barriers and obtain the access to the international market;

- Enhance employees’ sense of responsibility, motivation, and dedication.

Application Scenario

With the increasing regulatory efforts in the medical device industry and rising attention of social groups to the quality of medical devices, the acceptance of ISO13485 in this industry will continue to improve. Given the requirements for the entire life cycle of medical devices from raw materials to final disposal of products, all enterprises within the life cycle of medical devices can apply for this service.

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