Chinese premier signs decree unveiling revised rule on medical equipment supervision

BEIJING, March 19 (Xinhua) -- Chinese Premier Li Keqiang has signed a State Council decree unveiling a revised regulation on the supervision and management of medical equipment.

The new regulation aims to further promote innovation and better meet people's expectations for high-quality medical equipment amid the rapid development of the industry, the State Council said in a statement.

It will come into effect on June 1. A State Council executive meeting on Dec. 21 adopted the draft revision.

The new regulation requires the registrants or filing applicants of medical equipment to shoulder the responsibility for the safety and efficacy of medical equipment by setting up and effectively running a quality management system, strengthening the postmarket management of their products, and establishing a traceability and recall system.

After the new regulation comes into effect, the punishment for breaking the rules will be more severe while the costs will be higher.

The new regulation further improves the country's system of medical equipment supervision. More efforts will go to making the supervision team more professional and specialized while the means of supervision will be enhanced.

It also encourages innovation and will streamline the approval process for such innovation.