Regulations on the safety and protection of radioisotope and ray devices.

The purposes of these Regulations is to strengthen the supervision and administration of the safety and protection of radioisotopes and radiation devices, promote the safe application of radioisotopes and radiation devices, safeguarding the human health and protecting the environment. The Regulations consist of 69 Articles divided into 7 Chapers: General Provisions: Licensing and Filing; Safety and Protection (III); Emergency Response to Radiation Accidents (IV); Supervision and inspection (V); Legal liabilities (VI); Supplementary provisions (VII).
The Regulations govern the production, sale and use of radioisotopes and radiation devices as well as the transfer, import and export of radioisotopes. The term “radioisotopes” as mentioned in this Regulation shall include radioactive sources and unsealed radioactive substances. The state shall implement the classified administration of radioactive sources and radiation devices. In accordance with the degree of potential harm of radioactive sources and radiation devices to human health and environment, radioactive sources may be divided, from high to low, into Class I, Class II, Class III, Class IV and Class V; radiation devices may be divided into Class I, Class II and Class III.
An entity producing, selling or using radioisotope and ray devices shall obtain the relevant licenses. A medical or health institution using radioisotopes or radiation devices for radiation diagnosis and therapy shall also obtain an institutional license for radioactive source diagnosis and therapy technologies and medical radiation. The competent department of foreign trade of the State Council shall formulate and publish a catalogue of radioisotopes restricted from import and export and a catalogue of radioisotopes prohibited from import and export. For the import of any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the competent department of foreign trade of the State Council shall, after the examination and approval of the competent department of environmental protection of the State Council, issue an import license according to the relevant provisions of the state on foreign trade.