ISO13485

ISO 13485 is called "Quality Management System for Medical Devices" in Chinese. As medical devices are special products that save lives and treat diseases, it is not enough to regulate them according to the general requirements of ISO 9000 standards. Therefore, ISO has issued ISO 13485:1996 version standards (YY/T0287 and YY/T0288), which provide specific requirements for the quality management system of medical device manufacturers and play a good role in promoting the safety and effectiveness of medical device quality.

Application for ISO13485 Medical Device Quality Management System Certification Registration Requirements:
1. The applying organization should hold a legal entity business license or a document proving its legal status.
2. Has obtained a production license or other qualification certificate (when required by national or departmental regulations);
3. The products covered by the quality management system applying for certification should comply with relevant national standards, industry standards, or registered product standards (enterprise standards), and the products should be standardized and mass-produced.
4. The applying organization shall establish a management system that complies with the certification standards to be applied for, and for medical device production and operation enterprises, it shall also comply with the requirements of YY/T 0287 standard. For enterprises producing Class III medical devices, the quality management system operation time shall not be less than 6 months, and for enterprises producing and operating other products, the quality management system operation time shall not be less than 3 months. And have undergone at least one comprehensive internal audit and one management review.
5. Within one year prior to submitting the certification application, there have been no significant customer complaints or quality incidents regarding the products of the applying organization.

The significance of ISO13485 certification:

1. Improve and enhance the management level of enterprises, avoid legal risks, and increase the visibility of enterprises;
2. Improve and ensure the quality level of products to enable enterprises to achieve greater economic benefits;
3. Beneficial for eliminating trade barriers and obtaining a passport to enter the international market;
4. Beneficial for enhancing product competitiveness and increasing market share.
5. Through effective risk management, the risk of product quality accidents or adverse events can be effectively reduced.
6. Enhance employees' sense of responsibility, motivation, and dedication.