{"id":1635,"date":"2022-08-24T17:18:43","date_gmt":"2022-08-24T10:18:43","guid":{"rendered":"https:\/\/mednovum.com.vn\/?p=1635"},"modified":"2022-08-24T17:27:55","modified_gmt":"2022-08-24T10:27:55","slug":"thong-tu-06-2022-tt-byt-quy-dinh-danh-muc-va-cap-so-luu-hanh-trang-thiet-bi-y-te-phuc-vu-phong-chong-dich-covid-19-trong-truong-hop-cap-bach","status":"publish","type":"post","link":"http:\/\/mednovum.com.vn\/en\/thong-tu-06-2022-tt-byt-quy-dinh-danh-muc-va-cap-so-luu-hanh-trang-thiet-bi-y-te-phuc-vu-phong-chong-dich-covid-19-trong-truong-hop-cap-bach\/","title":{"rendered":"Circular 06\/2022\/TT-BYT regulating the list and issuance of circulation numbers for medical equipment serving COVID-19 prevention and control in urgent cases"},"content":{"rendered":"
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\u21d3 View and download Circular<\/span><\/strong><\/p>\n\n\t\t<\/div>\n\t<\/div>\n

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Circular 06\/2022\/TT-BYT regulating the list and issuance of circulation numbers for medical equipment serving COVID-19 prevention and control in urgent cases<\/h3><\/div> <\/div> <\/div> <\/a><\/div> <\/div><\/div><\/div><\/div>
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\u2014\u2014\u2013<\/p>\n

 <\/p>\n\n\n\n\n
MINISTRY OF HEALTH
\n\u2014\u2014-<\/strong><\/td>\n		SOCIALIST REPUBLIC OF VIETNAM
\nIndependence \u2013 Freedom \u2013 Happiness
\n\u2014\u2014\u2014\u2014\u2014<\/strong><\/td>\n<\/tr>\n
Number: 06\/2022\/TT-BYT<\/td>\n\n

Hanoi, August 1, 2022<\/em><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

CIRCULAR<\/strong><\/p>\n

REGULATIONS ON THE LIST AND ISSUANCE OF CIRCULATION NUMBERS FOR MEDICAL EQUIPMENT FOR PREVENTION AND CONTROL OF COVID-19 EPIDEMIC IN EMERGENCY CASES<\/p>\n

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;<\/em><\/p>\n

Pursuant to Decree No. 98\/2021\/ND-CP dated November 8, 2021 of the Government on medical equipment management;<\/em><\/p>\n

At the request of the Director of the Department of Medical Equipment and Construction;<\/em><\/p>\n

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.<\/em><\/p>\n

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<\/strong><\/p>\n

1. PCR machine.<\/p>\n

2. Chemicals (biological products) to run the PCR machine to test for SARS-CoV-2.<\/p>\n

3. Rapid test kit for SARS-CoV-2 antigen\/antibody.<\/p>\n

4. High function ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high flow oxygen machines, portable ventilators.<\/p>\n

5. Continuous hemodialysis machine.<\/p>\n

6. Mobile X-ray machine.<\/p>\n

7. Blood gas meter (measures electrolytes, lactate, hematocrite).<\/p>\n

8. Patient monitor \u2265 5 parameters.<\/p>\n

9. Electric syringe pump; Infusion pump.<\/p>\n

10. Pacemaker defibrillator.<\/p>\n

11. Blood clotting time meter.<\/p>\n

12. Hemodynamic monitor.<\/p>\n

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<\/strong><\/p>\n

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).<\/p>\n

Article 3. Entry into force<\/strong><\/p>\n

1. This Circular takes effect from August 1, 2022.<\/p>\n

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.<\/p>\n

Article 4. Transitional provisions<\/strong><\/p>\n

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.<\/p>\n

Article 5. Implementation<\/strong><\/p>\n

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.<\/p>\n

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.\/.<\/p>\n\n\n\n
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 <\/p>\n

Recipient:
\n<\/em><\/strong>\u2013 Social Committee of the National Assembly;
\n\u2013 Government Office (Department of KGVX, Official Gazette,
\nGovernment Portal);
\n\u2013 Ministry of Justice (Department of Inspection of Legal Documents);
\n\u2013 Ministries, ministerial-level agencies, Government agencies;
\n\u2013 Q. Minister of Health (for report);
\n\u2013 Deputy Ministers of Health (for coordination and direction);
\n\u2013 People's Committees of provinces and centrally-run cities;
\n\u2013 Department of Health of provinces and centrally run cities;
\n\u2013 Department of Science and Technology of provinces,
\ncentrally run city;
\n\u2013 Vietnam Social Security;
\n\u2013 Units under the Ministry of Health; health of ministries and branches;
\n\u2013 Departments, Bureaus, General Departments, Ministry Office, Ministry Inspectorate; Ministry of Health's electronic information portal;
\n\u2013 Save: VT, PC, TB-CT.<\/p><\/td>\n

\n

KT. MINISTER<\/strong>
\nDEPUTY MINISTER<\/strong><\/p>\n

Do Xuan Tuyen<\/strong><\/p><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

APPENDIX I<\/strong><\/p>\n

(Issued with Circular No. 06\/2022\/TT-BYT dated August 1, 2022 of the Minister of Health)<\/em><\/p>\n\n\n\n\n
MINISTRY OF HEALTH
\n\u2014\u2014-<\/strong><\/td>\n		SOCIALIST REPUBLIC OF VIETNAM
\nIndependence \u2013 Freedom \u2013 Happiness
\n\u2014\u2014\u2014\u2014\u2014<\/strong><\/td>\n<\/tr>\n
Number: \u2026\u2026\u2026\u2026\u2026.<\/td>\n\n

Hanoi, date \u2026 month \u2026 year 20\u2026<\/em><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

CERTIFICATE OF REGISTRATION FOR CIRCULATION OF MEDICAL EQUIPMENT OF TYPE C, D FOR PREVENTION AND CONTROL OF COVID-19 EPIDEMIC IN EMERGENCY CASES<\/strong><\/p>\n

Pursuant to Decree No. 98\/2021\/ND-CP dated November 8, 2021 of the Government on medical equipment management;<\/p>\n

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.<\/p>\n

The Ministry of Health issues a certificate of registration for circulation of medical equipment (new 100%) as follows:<\/p>\n

1. Name of medical equipment:<\/p>\n

2. Trade name:<\/p>\n

3. Global Medical Device Nomenclature code \u2013 GMDN (if any):<\/em><\/p>\n

4. Types:<\/p>\n

5. Product code (if any):<\/em><\/p>\n

6. Packaging specifications (if any):<\/em><\/p>\n

7. Type of medical equipment:<\/p>\n

8. Purpose of use:<\/p>\n

9. Name and address of the manufacturing facility:<\/p>\n

10. Name and address of the owner of the medical equipment:<\/p>\n

11. Name and address of the owner of the circulation number:<\/p>\n

12. Name and address of warranty facility (if any):<\/em><\/p>\n

The circulation number is valid from the date of signing and issuance to the date \u2026\u2026<\/p>\n

 <\/p>\n\n\n\n
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 <\/p>\n

Recipient:
\n<\/em><\/strong>\u2026\u2026<\/p><\/td>\n

\n

POSITION OF THE SIGNOR<\/strong>
\nSignature (Full name and title)<\/em>
\nConfirm by stamp or signature
\n<\/em><\/p><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"⇓ Xem và tải Thông tư Thông tư 06\/2022\/TT-BYT quy định danh mục và cấp số lưu hành trang thiết bị y tế phục vụ phòng, chống dịch COVID-19 trong","protected":false},"author":4,"featured_media":268,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4],"tags":[],"class_list":["post-1635","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-co-so-phap-ly","category-van-ban-phap-quy"],"acf":[],"_links":{"self":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/posts\/1635","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/comments?post=1635"}],"version-history":[{"count":0,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/posts\/1635\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media\/268"}],"wp:attachment":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media?parent=1635"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/categories?post=1635"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/tags?post=1635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}