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Decentralization of authority to examine and approve imported medical devices in China

Click Rate:6773    Datetime:2018/4/10  

On April 8, the State Council issued a decision on suspending the implementation of the regulations on Supervision and Administration of Medical Devices in the International Medical Tourism area of Boao Le City, Hainan (hereinafter referred to as "decision").Import approval shall be carried out by Hainan Provincial Government and used in designated medical institutions.Industry experts pointed out that the "decision" means that China's pilot import of medical devices for the first time from the state to the local authority, but also conducive to the rapid entry of foreign advanced medical equipment into the country.


Public information shows that the current domestic import of medical devices approved by the State Council food and drug regulatory authority.After suspending the implementation of the relevant provisions of the current regulations on Supervision and Administration of Medical Devices, for the pilot provinces, the authority to examine and approve imported medical devices will be delegated to the local government.


It is reported that at present, the import of medical devices in our country involves the second kind, the third kind of medical devices, that is, by the medium risk or the higher risk, special measures should be taken to strictly control the management to ensure the safety and effectiveness of the medical devices.In January, the website of the State Administration of Food and Drug Administration announced a total of 88 products approved for registered medical devices, with imports of the second and third categories accounting for 58 percent of the total approved products.


Chen Hongyan, deputy secretary general of the China Medical supplies Association and secretary general of the Medical Devices Branch, said thatThe devolution of the approval of imported medical equipment in Hainan Province will play a greater role in promoting both the medical tourism industry in Hainan Province and the domestic medical device industry as a whole.For Hainan Province, it is possible to support the pilot development of international medical tourism-related industries in Hainan Province by means of tourism and medical treatment, so as to attract and retain tourists.For domestic medical devices, science and technology have a guiding nature, foreign advanced medical equipment can quickly enter the country, can promote the innovation and development of domestic enterprises.


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