Decision No. 32/2007/QĐ-BKHCN Issuing regulations on the inspection of medical diagnostic X-ray equipment

Pursuant to …;

Issuing Regulations on the Inspection of Medical Diagnostic X-ray Equipment

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THE MINISTER

MINISTRY OF SCIENCE AND TECHNOLOGY

 

Pursuant to Decree No. 54/2003/NĐ-CP dated May 19, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology, and Decree No. 28/2004/NĐ-CP dated January 16, 2004 of the Government amending and supplementing certain articles of Decree No. 54/2003/NĐ-CP dated May 19, 2003;

Pursuant to Decree No. 50/1998/NĐ-CP dated July 16, 1998 of the Government detailing the implementation of the Radiation Safety and Control Ordinance;

Considering the proposal of the Director of the Radiation and Nuclear Safety Control Department,

 

DECISION:

 

Article 1. These Regulations on the Inspection of Medical Diagnostic X-ray Equipment are hereby issued together with this Decision.

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.

Article 3. The Radiation and Nuclear Safety Control Department and relevant agencies, organizations, and individuals are responsible for implementing this Decision./.

 

REGULATIONS

On the Inspection of Medical Diagnostic X-ray Equipment

(Issued together with Decision No. 32/2007/QĐ-BKHCN dated December 31, 2007 of the Minister of Science and Technology)

dated December 31, 2007 (of the Minister of Science and Technology)

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PART I

GENERAL PROVISIONS

Article 1. Inspection of Medical Diagnostic X-ray Equipment

1. Inspection of medical diagnostic X-ray equipment is the process of determining and certifying the reliable operating mode of the equipment compared to its design, carried out by authorized inspection organizations.

2. Medical diagnostic X-ray equipment must be inspected and calibrated after initial installation, reinstallation, or repair before being put into use, and must undergo annual inspections during operation.

3. Organizations using medical diagnostic X-ray equipment must comply with the provisions of Clause 2 of this Article.

Article 2. Inspection Procedures

The inspection of medical diagnostic X-ray equipment shall be conducted according to procedures corresponding to each type of equipment as specified in Appendices I, II, and III of these Regulations.

Article 3. Organizations and Individuals Authorized to Conduct Inspections of Medical Diagnostic X-ray Equipment

1. Only the following organizations are permitted to conduct inspections of medical diagnostic X-ray equipment:

a) Healthcare facilities that self-inspect their own medical diagnostic X-ray equipment and meet the conditions stipulated in Article 6 of these Regulations (hereinafter referred to as Self-Inspection Healthcare Facilities);

b) Service organizations that inspect medical diagnostic X-ray equipment and meet the conditions stipulated in Article 7 of these Regulations (hereinafter referred to as Inspection Service Organizations).

Self-Inspection Healthcare Facilities and Inspection Service Organizations are collectively referred to as Inspection Organizations.

2. Individuals may only conduct inspections of medical diagnostic X-ray equipment when working in the organizations mentioned in Clause 1 of this Article and meeting the qualification requirements stipulated in Clause 1 of Article 6 of these Regulations (hereinafter referred to as Inspection Personnel).

Article 4. Responsibilities of the Radiation and Nuclear Safety Control Department

1. To organize the assessment and evaluation of capabilities to recognize the ability or issue radiation safety service permits for the inspection of medical diagnostic X-ray equipment.

2. To inspect and audit compliance with regulations on the inspection of medical diagnostic X-ray equipment and handle violations in such activities within its authority.

3. To resolve complaints and reports related to the inspection of medical diagnostic X-ray equipment.

Article 5. Responsibilities of Organizations Conducting Medical Diagnostic X-ray Equipment Inspections

1. Carry out inspections of medical diagnostic X-ray equipment according to the corresponding procedures specified in Appendices I, II, and III of this Regulation.

2. Calibrate inspection equipment once every twelve months.

3. Prepare inspection result records. Specifically, organizations providing inspection services must prepare two copies of the inspection result record, one copy to be returned to the customer and one copy to be kept in the file.

4. Retain inspection result files for at least five years.

5. Report to the Radiation Control and Nuclear Safety Administration when there is a change in inspection staff, accompanied by the new inspector's declaration form according to Form No. 03 in Appendix VI of this Regulation.

6. Annually, prepare and submit reports (before November 30) on the medical diagnostic X-ray equipment inspection activities carried out during the year to the Radiation Control and Nuclear Safety Administration according to Form No. 01, and to the local Science and Technology Department and Health Department where the inspected equipment is located according to Form No. 02 specified in Appendix IV of this Regulation; submit ad hoc reports as required by these authorities.

7. Be subject to inspection and audit by competent state management agencies regarding the inspection of medical diagnostic X-ray equipment in accordance with current regulations.

8. Be responsible for the results of the inspection.

Chapter II

REQUIREMENTS FOR INSPECTION ORGANIZATIONS

Article 6. Medical Institutions Conducting Self-inspection

Medical institutions conducting self-inspection must meet the following conditions:

1. Have at least one inspector meeting the following qualification requirements:

a) Graduated from university or college and hold a certificate of completion of a training course on medical diagnostic X-ray equipment inspection and radiation safety issued by the Radiation Control and Nuclear Safety Administration, or

b) Graduated from a university majoring in medical physics.

2. Have sufficient inspection equipment according to the corresponding procedures for inspecting medical diagnostic X-ray equipment specified in Appendices I, II, and III of this Regulation and calibrated in accordance with Clause 2 of Article 5 of this Regulation.

3. Have a quality assurance program for inspection activities with contents specified in Appendix V of this Regulation.

4. Hold a certificate recognizing the capability to inspect medical diagnostic X-ray equipment issued by the Radiation Control and Nuclear Safety Administration.

Article 7. Inspection Service Organizations

Inspection service organizations must meet the following conditions:

1. The conditions stipulated in Clauses 1, 2, and 3 of Article 6 of this Regulation.

2. Hold a radiation safety service permit issued by the Radiation Control and Nuclear Safety Administration.

Chapter III

RECOGNITION OF SELF-INSPECTION CAPABILITY,

ISSUANCE OF RADIATION SAFETY SERVICE LICENSES

Article 8. Recognition of Self-inspection Capability

1. Medical institutions conducting self-inspection must submit a request for recognition of inspection capability for medical diagnostic X-ray equipment according to the form specified in Appendix VI of this Regulation to the Radiation Control and Nuclear Safety Administration.

2. Within thirty working days from the date of receipt of the complete application for recognition of inspection capability, the Radiation Control and Nuclear Safety Administration must organize an assessment of the application, conduct on-site inspections, and evaluate the capabilities of the applying medical institution according to Clauses 1, 2, and 3 of Article 6 of this Regulation, and proceed to issue or notify the refusal to issue a certificate recognizing the capability to inspect medical diagnostic X-ray equipment to the applying medical institution. The certificate recognizing the capability to inspect medical diagnostic X-ray equipment must clearly state the condition that the medical institution conducting self-inspection must fulfill all responsibilities as stipulated in Article 5 and ensure the conditions specified in Clauses 1, 2, and 3 of Article 6 of this Regulation.

3. Costs for inspection and on-site evaluation activities of state management agencies to recognize inspection capability shall be borne by the medical institution conducting self-inspection according to the current travel expense regulations.

Article 9. Issuing a Radiation Safety Service Permit

1. The radiation safety service inspection organization must submit the application file for a Radiation Safety Service Permit according to the form prescribed in Appendix VI of this Regulation to the Radiation and Nuclear Safety Control Department.

2. Within thirty working days from the date of receiving the complete application file for a Radiation Safety Service Permit, the Radiation and Nuclear Safety Control Department must organize the review of the application file, conduct on-site inspections, and evaluate the organization's capability based on the conditions stipulated in Clause 1 of Article 7 of this Regulation, and proceed to issue or notify the refusal to issue a Radiation Safety Service Permit to the requesting organization. The Radiation Safety Service Permit must clearly state the condition that the inspection service organization must fulfill all responsibilities as prescribed in Article 5 and ensure the conditions stipulated in Clauses 1, 2, and 3 of Article 6 of this Regulation.

3. The organization applying for a Radiation Safety Service Permit must pay fees and charges as prescribed in Decision No. 38/2006/QD-BTC dated July 24, 2006 of the Ministry of Finance regarding the determination of fee and charge levels, collection, payment, management, and utilization in the field of radiation safety and control.

Article 10. Duration and Renewal of the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection and the Radiation Safety Service Permit

1. The duration of the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection and the Radiation Safety Service Permit is three years.

2. At least sixty (60) days before the expiration of the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection or the Radiation Safety Service Permit, if the inspection organization wishes to continue performing these tasks, it must submit the renewal application file according to the form prescribed in Appendix VII of this Regulation to the Radiation and Nuclear Safety Control Department.

3. Within thirty working days from the date of receiving the complete renewal application file, the Radiation and Nuclear Safety Control Department is responsible for processing and renewing or notifying the refusal to renew the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection and the Radiation Safety Service Permit for the requesting organization.

4. Self-inspection medical facilities applying for renewal of the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection must ensure funding for the on-site evaluation activities of the state management agency according to the current travel expense regulations. The inspection service organizations applying for renewal of the Radiation Safety Service Permit must pay renewal fees and charges according to Decision No. 38/2006/QD-BTC dated July 24, 2006 of the Ministry of Finance regarding the determination of fee and charge levels, collection, payment, management, and utilization in the field of radiation safety and control.

Chapter IV

IMPLEMENTING PROVISIONS

Article 11. Handling Violations

1. If the radiation safety service inspection organization does not comply with the conditions of the Radiation Safety Service Permit, it will be handled according to the provisions of Decree No. 51/2006/NĐ-CP dated May 19, 2006 of the Government concerning "Administrative Sanctions for Violations in the Field of Radiation Safety and Control."

2. If self-inspection medical facilities do not comply with the conditions of the Certificate of Capability for Medical Diagnostic X-ray Equipment Inspection, they will be treated similarly to the radiation safety service inspection organizations that do not comply with the conditions of the Radiation Safety Service Permit.

Article 12. Guidance on Implementation

1\. Decisions recognizing the capability to calibrate measuring instruments (medical X-ray diagnostic equipment) issued by the General Department of Standardization, Metrology and Quality before the effective date of Decision No. 13/2007/QĐ-BKHCN dated July 6, 2007 of the Minister of Science and Technology on the issuance of the "List of Measuring Instruments Required for Calibration" shall remain valid as radiation safety service permits until such Decisions recognizing the capability to calibrate measuring instruments (medical X-ray diagnostic equipment) become invalid. After the expiration of these Decisions, organizations inspecting medical X-ray diagnostic equipment must complete procedures to apply for certificates recognizing their capability to inspect medical X-ray diagnostic equipment or radiation safety service permits in accordance with this Regulation.

2\. The Radiation and Nuclear Safety Control Agency is responsible for guiding the implementation of this Regulation.

3\. During the implementation process, if there are any difficulties, they should be reported to the Ministry of Science and Technology for prompt resolution./.