In order to promote the production of medical equipment quality management standards implementation work, according to the "Regulations on the supervision and administration of medical devices" (State Council Order No. 650th) and "medical device manufacturing supervision and management methods" (the State Administration of food and drug administration order No. seventh) regulations, the relevant matters are hereby notified as follows:

A, sterile and implantable medical device production enterprise shallcontinue in accordance with the production of medical equipment quality management requirements, establish a sound with the production ofmedical equipment to adapt to the quality management system and ensure its effective operation.

Two, since October 1, 2014, when a new run medical equipment manufacturing enterprises, the existing medical device manufacturers to increase production of third types of medical equipment, transfer orincrease production site, shall be in accordance with the production of medical equipment quality management specification.

Three, since January 1, 2016, all third types of medical equipmentproduction enterprise shall conform to the production of medical equipmentquality management specification.

Four, since January 1, 2018, all the medical device production enterprise shall conform to the production of medical equipment quality managementspecification.

Five, medical equipment manufacturing enterprises should actively in accordance with the norms of quality management of medical equipment production and related requirements for rectification, and constantly improve the quality management system, improve overall qualitymanagement assurance ability, achieve the medical device productionquality management specification requirements within the prescribed time limit. Within the prescribed time limit according to the existing provisions ofthe former still.

Six, food and drug supervision and management departments at all levelsshall strengthen the implementation of medical equipment productionimplementation and guiding quality management rules, does not meet thespecification of medical device manufacturing and quality managementrequirements of the production enterprises within the prescribed time limit,shall be handled in accordance with the "Regulations" the relevant provisions of the supervision and administration of medical devices.

Source: Food and Drug Administration