The radioisotopes referred to in these Regulations include radioactive sources and unsealed radioactive substances. Article 3 The competent department of environmental protection under the State Council shall carry out unified supervision and management of the safety and protection of radioisotopes and ray devices throughout the country.
Departments of the State Council, such as public security and health, shall, in accordance with the division of responsibilities and the provisions of these Regulations, supervise and manage the safety and protection of radioisotopes and radiation devices.
The competent department of environmental protection of the local people's government at or above the county level and other relevant departments shall, in accordance with the division of responsibilities and the provisions of these Regulations, supervise and manage the safety and protection of radioisotopes and radiation devices in their administrative areas. Article 4 The State shall implement categorized management of radioactive sources and radiation devices. According to the radioactive sources, radiation devices on human health and the environment of the potential hazards, from high to low radioactive sources are divided into Class I, Class Ⅱ, Class Ⅲ, Class Ⅳ, Class V, the specific classification of the competent department of the State Council Department of Environmental Protection; radiation devices are divided into Class Ⅰ, Class Ⅱ, Class Ⅲ, the specific classification of the competent department of the State Council Department of Environmental Protection, the State Council Department of Health developed. Chapter II Licensing and Filing Article 5 The production, sale and use of radioisotopes and radiation devices shall be licensed in accordance with the provisions of this chapter. Article 6 The licenses for units producing radioisotopes, selling and using Class I radioactive sources and selling and using Class I radiation devices shall be approved and issued by the competent department for environmental protection under the State Council.
Licenses for units other than those provided for in the preceding paragraph shall be approved and issued by the competent department for environmental protection under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
The competent environmental protection department of the state council to the production of radioisotopes to the unit before the issuance of licenses, shall print the application materials to the competent authorities of its industry for comments.
The competent department of environmental protection shall notify the public security department at the same level, the competent health department for approval of the issuance of licenses. Article 7 The production, sale and use of radioisotopes and radiation devices units applying for a license shall have the following conditions:
(1) with the scale of production, sale and use of the activities engaged in, with the appropriate professional knowledge and protection of professional and technical personnel with the appropriate professional knowledge and health conditions;
(2) have in line with the national standards for environmental protection, occupational health standards and safety and protection requirements of the premises, facilities and equipment;
(c) have a special safety and protection management organization or full-time or part-time safety and protection management personnel, and equipped with the necessary protective supplies and monitoring instruments;
(d) have a sound safety and protection management rules and regulations, and emergency response to radiation accidents;
(e) generation of radioactive waste gas, waste liquid, Solid waste, with radioactive waste gas, waste liquids, solid waste to ensure that the discharge of standard treatment capacity or feasible treatment program. Article 8 Units producing, selling or using radioisotopes and radiation devices shall apply for a license in advance to the competent department for environmental protection which has the right of approval, and submit supporting materials that meet the conditions stipulated in Article 7 of these Regulations.
The use of radioisotopes and radiation devices for radiological diagnosis and treatment of medical and health institutions, but also should obtain a radioactive source diagnosis and treatment technology and medical radiation agency license. Article IX of the environmental protection department shall accept the application within 20 working days from the date of completion of the review, meet the conditions, the issuance of licenses, and shall be announced; does not meet the conditions, notify the applicant in writing and explain the reasons. Article 10 The license includes the following main contents:
(1) the unit's name, address, legal representative;
(2) the type and scope of activities engaged in;
(3) the validity period;
(4) the date of issuance and certificate number. Article XI of the licensee to change the name of the unit, address, legal representative, shall, within 20 days from the date of registration of the change, to the original licensing authority to apply for a license change procedures. Article XII of the following circumstances, the licensee shall apply in accordance with the original application procedures, re-apply for a license:
(a) change the type or scope of activities engaged in;
(b) new or altered, expanding the production, sales, use of facilities or premises. Article XIII license is valid for five years. The expiration of the validity period, the need for continuation, the licensee shall be valid for 30 days before the expiration of the license, to the original licensing authority to apply for continuation. The original licensing authority shall accept the continuation of the application from the date of expiration of the license to complete the review, meet the conditions to be continued; does not meet the conditions, notify the applicant in writing and explain the reasons. Article XIV of the licensee to partially terminate or completely terminate the production, sale, use of radioisotopes and radiation device activities, should be part of the original licensing authority to apply for change or cancellation of the license by the original licensing authority to verify the eligibility of the license shall be changed or canceled. Article 15 It is prohibited to engage in the production, sale or use of radioisotopes and radiation devices without a license or not in accordance with the types and scope specified in the license.
It is prohibited to forge, alter or transfer the license.