State Food and Drug Administration to adjust some changes to the approval of medical devices and quality management system and inspection duties

　　To implement the " State Council reform and functional transformation program " to further deepen the reform of administrative examination and approval system for medical devices , according to "the State Council on the issuance of the major responsibilities of internal organs and the development of compliance officers State Food and Drug Administration 's notice" ( State Office Fa [ 2013 ] No. 24) requires the State food and Drug administration decided to adjust some of the duties to assume the provincial food and drug supervision and management departments . Recently, the Administration issued a circular on the matter .
　　The circular pointed out that since October 1, 2013 , will be part of the territory in accordance with the provisions of the General Administration of Class III medical devices carry a certificate of registration and approval items adjusted to change the provincial food and drug administration departments. Since October 1, 2013 , will be part of the Administration to carry out within the third category of in vitro diagnostic reagents entry change to adjust to the approval of the provincial food and drug supervision and management departments to implement . Since July 1, 2013 , part of the medical device original State Food and Drug Administration Drug Certification Center organized the third category of in vitro diagnostic reagents and quality management system inspection ( examination ) work adjustment to the provincial food and drug administration departments to implement .
　　Notice of the change on the medical device approval inspection duties and responsibilities of the quality management system to adjust the work to make specific comments . And asked the provincial food and drug supervision departments should attach great importance to the duties adjustment , fully prepared to complete the information system adjustment , strict admissibility criteria , requirements specification review and strengthen food and drug administration departments at all levels of communication , to ensure the implementation of the work .
Global sales of hearing aids for their situation is the beginning of three-legged
　　To know the specific hearing aid sales data really difficult, especially in the Asia Pacific region, including China , but the high demand for these diminished expectations of industry data . China Netcom audiology its partners and its own database in the world, has been trying to collect, analyze and publish , became the authoritative data publishing organization . Recently, the Chinese audiology network will gradually release the latest industry data , the most important is the global hearing aid sales data.
　　According to analysis of Chinese audiology network, the total global sales of hearing aids has shipped over 10 million units, from major regional and economic development point of view , has initially formed a global full three-legged posture , namely: the United States , Europe and Asia each one-third of the market share , but slightly larger amount in Europe , the United States accounted for 31 %, Europe 38% , while Asia and the Pacific 22% , the rest of the country a total of only 9%. If subdivided , then the United States annually hearing aid sales of 280 million units , while Germany 8% , Japan 7% , which basically represents the height of the aging developed a hearing aid penetration. According to the rapid development of China's recent test , the country could become the world's fourth largest single hearing aid sales , estimated at around 3.5-4 %.
Growth of the global hearing aid station number is between 2-4 % , in 2012 the number of U.S. units net growth of 2.9 % in the past decade, the growth rate of the U.S. hearing aid sales hovered between 2-4% . Due to the global economic recession and some European countries to cut subsidies , such as Norway and Switzerland , for the sale of hearing aids are also affected to some extent , we have seen growth in Europe about hearing aids 2% , below the historical growth trend. However , sales in emerging countries also began hearing aids , including some countries in South and Southeast Asia demand gradually strengthening .

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