What do applications for radiation-related affair permit - use of diagnostic X-ray devices in medical in Vietnam comprise?
What do applications for radiation-related affair permit - use of diagnostic X-ray devices in medical in Vietnam comprise? What do applications for issuance of radiation-related affair permit – operation of irradiators in Vietnam comprise?
Please advise.
1. What do applications for radiation-related affair permit - use of diagnostic X-ray devices in medical in Vietnam comprise?
Pursuant to Article 20 of Decree 142/2020/ND-CP stipulating applications for radiation-related affair permit - use of diagnostic X-ray devices in medical are as follows:
1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.
2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.
3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.
4. Copies of certificates of radiation employees of safety personnel. In case safety personnel have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.
5. Copies of certificates for radiation safety training of radiation employees.
6. Declarations of diagnostic X-ray devices in medical using Form No. 7 under Annex III of this Decree.
7. Copies of manufacturers’ documents providing information on diagnostic X-ray in medical as stated in the declarations. In case manufactures’ documents on such information are not available, applicants must submit verification results of devices’ technical specifications.
8. Copies of assessment certificates of diagnostic X-ray devices in medical.
9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 5 under Annex V of this Decree.
10. Copies of radiation monitoring records.
11. Response plans shall conform to Annex II of this Decree.
2. What do applications for issuance of radiation-related affair permit – operation of irradiators in Vietnam comprise?
According to Article 21 of Decree 142/2020/ND-CP, applications for issuance of radiation-related affair permit – operation of irradiators are as follows:
1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.
2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.
3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.
4. Copies of certificates for radiation employees of employees specified under Point a and Point b Clause 1 Article 8 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.
5. Copies of certificates for radiation safety training of radiation employees. Copies of certificates or degrees on medical physics training for medical physics employees of radiotherapy facilities.
6. Declarations of irradiators using corresponding form under Annex III of this Decree.
7. Copies of manufacturers’ documents providing information on irradiators as stated in the declarations. In case manufactures’ documents on such information are not available, applicants must submit verification results of irradiators’ technical specifications.
8. Copies of assessment certificates for irradiators used in medical.
9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 6 under Annex V of this Decree.
10. Copies of radiation monitoring records.
11. Response plans shall conform to Annex II of this Decree.
Best Regards!
