State Council: Imported medical devices that are not approved for registration in China can be used first in Hainan

Today (April 8), the website of the Central People's Government officially issued the "Decision of the State Council on Suspension of the Relevant Provisions on the Regulations on the Supervision and Administration of Medical Devices" in the Pilot Area of ​​International Medical Tourism in Boao Lecheng, Hainan (Guo Fa [2018] No. 10 ).

The "Decision" pointed out that in order to further support the pilot development of international medical tourism-related industries in Hainan Province, the State Council decided to suspend the implementation of the provisions of Article 21, paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices in the Pioneer Area of ​​International Medical Tourism in Boao Lehai, Hainan. Medical devices that are urgently needed in the medical institutions in the first place and that are not approved for registration in China, are approved by the Hainan Provincial People's Government for use in designated medical institutions.

The "Decision" also clarified that the State Drug Administration and the Hainan Provincial People's Government, in conjunction with relevant departments, formulate specific management measures, standardize the conditions and procedures for approval, and refine the use specifications of imported medical devices, monitoring of adverse events, import ports, etc. Regulatory responsibilities to ensure the safe use of imported medical devices and to effectively protect the health and safety of the people.

Attachment: Article 11 and the second paragraph of the Regulations

An overseas production enterprise that exports Class II and Class III medical devices to China shall submit its application for registration to the Food and Drug Administration of the State Council as an agent of its representative office established within the territory of China or an enterprise legal person designated within the territory of China. And the certification document that the competent authority of the country where the applicant is registered permits the sale of the medical device. (Central People's Government Network)

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