This Circular promulgates national technical regulations for linear accelerators used in radiation therapy to ensure safety and effectiveness when using this medical device. The standards apply to healthcare facilities, production units, and importers of the aforementioned equipment.
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CIRCULAR
Issuing the "National Technical Regulation on Linear Accelerators for Radiation Therapy"
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Pursuant to the Atomic Energy Law dated June 3, 2008;
Pursuant to the Standards and Technical Regulations Law dated June 29, 2006;
Pursuant to Decree No. 95/2017/NĐ-CP dated August 16, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;
Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing and guiding implementation of certain provisions of the Standards and Technical Regulations Law;
Pursuant to Decree No. 07/2010/NĐ-CP dated January 25, 2010 of the Government detailing and guiding implementation of certain provisions of the Atomic Energy Law;
Pursuant to Decree No. 39/2016/NĐ-CP dated May 15, 2016 of the Government detailing and guiding implementation of certain provisions of the Occupational Safety and Health Law;
At the proposal of the Director of the Radiation and Nuclear Safety Administration and the Head of the Legal Department;
The Minister of Science and Technology hereby issues the National Technical Regulation on Linear Accelerators for Radiation Therapy.
Article 1. This Circular annexes the National Technical Regulation on Linear Accelerators for Radiation Therapy (QCVN 13: 2017/BKHCN).
Article 2. This Circular takes effect from December 15, 2018.
Article 3. The Director of the Radiation and Nuclear Safety Administration, Heads of relevant agencies, organizations, and individuals are responsible for implementing this Circular.
During implementation, if any issues arise, agencies, organizations, and individuals shall promptly report to the Ministry of Science and Technology for study and amendment./.
VICE MINISTER
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