Recently, the regulations of the medical device industry have been intensively updated, and the dual supervision of the state and local governments has continued to increase! On June 20, the State Food and Drug Administration issued the "Measures on Optimizing the Supervision of the Whole Life Cycle to Support the Innovation and Development of High-end Medical Devices", and the "Quality Management Standards for Online Sales of Medical Devices" to be implemented on October 1 has put forward higher requirements for the industry. From strategic support at the national level, to the detailed implementation of local policies, to the evolution of international regulatory trends, every change in medical device regulations has attracted much attention.

Summary of the key points of the new regulations

1. Stricter qualification review

The new regulations require that all online medical devices must be "certified", and all products must have complete medical device registration certificates/filing certificates, which can be checked and verified on the official website and e-commerce platform pages.

2. Full coverage of quality control

From procurement to after-sales, the new regulations have established full-process quality management requirements. Therefore, it is extremely important to have a complete ISO 13485 quality management system to ensure that every product is traceable.

3. Transparent information makes you feel more at ease

The new regulations clearly require that product information be displayed in a standardized manner. All online product pages of enterprises must display complete information in accordance with the requirements of the regulations, including: registration certificate number, scope of application, contraindications and other key information.

Health is no small matter, choosing the right device is a big deal!

The new regulations on online sales of medical devices are introduced to make it safer and more assured for ordinary people to buy medical devices online!There are some "three-no" medical devices on the market now (no registration certificate, no production license, no quality assurance), the quality is not guaranteed, and using them may not only fail to cure the disease, but also endanger health. This time, the state strictly stipulates that all regular medical devices must be marked with the "National Medical Device Registration Permit/Medical Device Registration Entry/Medical Device Registration Permit" number, so that everyone can check the authenticity of the official website of the State Food and Drug Administration (https://www.nmpa.gov.cn) at any time to avoid being deceived.

We recommend that you must recognize the regular information of the product when purchasing, reject "three-no" products, and don't let your health become a "test product" for unscrupulous merchants! Forward to remind people around you to protect health and safety together!

Conclusion:

The continuous innovation of medical device regulations is aimed at promoting the development of the medical device industry in the direction of innovation, standardization and safety. Under the guidance of regulations, the medical device industry will continue to improve product quality and technical level, better serve the medical and health industry, and bring more high-quality medical solutions to patients. 

Source:

https://www.nmpa.gov.cn/yaowen/ypjgyw/ylqxyw/20250620174847121.html