Medical network - on July 13, Beijing, tianjin, liaoning, Shanghai, zhejiang, shandong, hubei, guangdong province (city) the food and drug administration, China's food and drug verification research institute (administration of medical devices standard management center), oral medicine oral medical equipment inspection center of Peking University, Beijing China YiXie uh guano certification co., LTD. :
According to the revision of the standard system for medical devices industry in 2017 work schedule and will now project revision of the standard system for medical devices industry in 2017 printed and distributed to you. Among them, the central subsidies to local medical instrument standard system revision project 71, the central financial support of medical instrument standard system revision 15 projects. To do a good job in the standard system revision will now about that notice the following:
A unit, the standard system revision project must be strictly in accordance with the "measures for the management of medical instrument standard" (the state food and drug supervision and administration of administration makes no. 33) for medical devices industry standard system revision work, ensure that all work tasks are completed as required.
Second, the administration of medical devices standard management center to seriously organize and coordinate the project units to carry out the standard system revision work, strengthening management and inspection guidance. To clear requirements relating to the compulsory standards, the related medical equipment standardization technical committee in the process of amending to understand and grasp the main products involved; To change to clear the contents of the revision of the standard, the standard implementation time and registered need clear requirements should be put forward technical advice, and in the standard examination and approval materials including the above content.
Three, each related provinces (municipalities), more attention must be paid to the food and drug administration to strengthen standard project and revising their respective administrative areas in charge of supervision and management of the unit, urged all relevant units in accordance with the relevant standard system revision work requirements, complete the standard drafting, authentication, for advice, review and approval work.
Four, each related provinces (municipalities) food and drug administration and medical equipment standard system revision project unit should strictly according to the regulations of the state financial funds management and financial system, individual, strengthen the supervision over the use process of the standard capital allocation and revising management, special fund is special, improve the service efficiency of funds.
The food and drug supervision administration office
On July 7, 2017
