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| MINISTRY OF HEALTH ——- |
SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ————— |
| Number: 06/2022/TT-BYT |
Hanoi, August 1, 2022 |
CIRCULAR
REGULATIONS ON THE LIST AND ISSUANCE OF CIRCULATION NUMBERS FOR MEDICAL EQUIPMENT FOR PREVENTION AND CONTROL OF COVID-19 EPIDEMIC IN EMERGENCY CASES
Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management;
At the request of the Director of the Department of Medical Equipment and Construction;
The Minister of Health issued a Circular stipulating the list and granting of circulation numbers for medical equipment serving the prevention and control of COVID-19 in urgent cases.
Article 1. List of medical equipment for COVID-19 prevention and control in urgent cases as prescribed in Clause 3, Article 29 of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management
1. PCR machine.
2. Chemicals (biological products) to run the PCR machine to test for SARS-CoV-2.
3. Rapid test kit for SARS-CoV-2 antigen/antibody.
4. High function ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high flow oxygen machines, portable ventilators.
5. Continuous hemodialysis machine.
6. Mobile X-ray machine.
7. Blood gas meter (measures electrolytes, lactate, hematocrite).
8. Patient monitor ≥ 5 parameters.
9. Electric syringe pump; Infusion pump.
10. Pacemaker defibrillator.
11. Blood clotting time meter.
12. Hemodynamic monitor.
Article 2. Supplementing the certificate of registration for circulation of medical equipment of type C and D serving the prevention and control of COVID-19 epidemic in urgent cases
Supplementing the form of certificate of registration for circulation of medical equipment of type C, D serving the prevention and control of COVID-19 epidemic in urgent cases (specified in Appendix I attached to this Circular).
Article 3. Entry into force
1. This Circular takes effect from August 1, 2022.
2. Circular No. 13/2021/TT-BYT dated September 16, 2021 of the Minister of Health regulating the issuance of circulation numbers and import of medical equipment for COVID-19 prevention and control activities in urgent cases ceases to be effective from the effective date of this Circular.
Article 4. Transitional provisions
Applications for issuance of circulation registration certificates for medical equipment of types C and D serving COVID-19 prevention and control that have been received by the Ministry of Health before January 1, 2022 will continue to be processed according to the provisions of Circular No. 13/2021/TT-BYT dated September 16, 2021 of the Minister of Health regulating the issuance of circulation numbers and import of medical equipment serving COVID-19 prevention and control activities in urgent cases.
Article 5. Implementation
Chief of the Ministry Office; Chief Inspector of the Ministry; Directors of Departments, Bureaus, and General Directors of the Ministry of Health; Directors of Health Departments of provinces and centrally run cities and relevant agencies, organizations, and individuals are responsible for implementing this Circular.
In the process of implementation, if there are any difficulties or problems, agencies, organizations and individuals are requested to promptly report to the Ministry of Health for consideration and resolution./.
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Recipient: |
KT. MINISTER Do Xuan Tuyen |
APPENDIX I
(Issued with Circular No. 06/2022/TT-BYT dated August 1, 2022 of the Minister of Health)
| MINISTRY OF HEALTH ——- |
SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ————— |
| Number: ……………. |
Hanoi, date … month … year 20… |
CERTIFICATE OF REGISTRATION FOR CIRCULATION OF MEDICAL EQUIPMENT OF TYPE C, D FOR PREVENTION AND CONTROL OF COVID-19 EPIDEMIC IN EMERGENCY CASES
Pursuant to Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management;
Pursuant to Circular No. /2022/TT-BYT dated August 2022 of the Minister of Health stipulating the list and issuance of circulation numbers for medical equipment serving the prevention and control of COVID-19 epidemic in urgent cases.
The Ministry of Health issues a certificate of registration for circulation of medical equipment (new 100%) as follows:
1. Name of medical equipment:
2. Trade name:
3. Global Medical Device Nomenclature code – GMDN (if any):
4. Types:
5. Product code (if any):
6. Packaging specifications (if any):
7. Type of medical equipment:
8. Purpose of use:
9. Name and address of the manufacturing facility:
10. Name and address of the owner of the medical equipment:
11. Name and address of the owner of the circulation number:
12. Name and address of warranty facility (if any):
The circulation number is valid from the date of signing and issuance to the date ……
|
Recipient: |
POSITION OF THE SIGNOR |