Circular No. 06/2022/TT-BYT stipulates the list and circulation number for medical devices serving the prevention and control of COVID-19 in emergency situations. This document applies to production facilities, importers, and users of medical devices.
Đối tượng áp dụng
["Production facilities", "Importers", "Users"]
Các điểm cốt lõi
- "PCR machine" → shall be granted a circulation number when it falls within the list prescribed in Article 1 of this Circular → no specific level, refer to Article 1
- Chemicals (biological products) for running PCR tests for SARS-CoV-2 → shall be granted a certificate of registration for medical device circulation type C, D according to the model prescribed in Appendix I of this Circular → no specific level, refer to Article 2
- Electric syringe pump; Infusion pump → must comply with regulations on circulation number and certificate of registration for medical device circulation as prescribed by the Ministry of Health → no specific level, refer to Article 1
- Coagulation time measuring machine; Hemodynamic measuring machine → shall be granted a certificate of registration for medical device circulation type C, D according to the model prescribed in Appendix I of this Circular → no specific level, refer to Article 2
- Applications for certificates of registration for circulation of medical devices type C, D submitted to the Ministry of Health before January 1, 2022 → shall continue to be processed according to the provisions of Circular No. 13/2021/TT-BYT → no specific level, refer to Article 4
🌐 Tác động xã hội từ văn bản này
- Production facilities, importers, and users of medical devices benefit from rapid issuance of certificates of registration for circulation in emergency situations.
- Citizens benefit from having more types of medical devices serving the prevention and control of COVID-19.
- Production facilities, importers, and users of medical devices must comply with regulations on circulation number and certificate of registration for circulation as stipulated in this Circular.
❓ Câu hỏi thường gặp
Which medical devices are eligible for circulation numbers?
"PCR machine," "Chemicals (biological products) for running PCR tests for SARS-CoV-2," and other medical devices listed in Article 1 of this Circular.
Must production facilities and importers comply with regulations on issuing certificates of registration for circulation?
Must comply with regulations on circulation number and certificate of registration for medical device circulation as stipulated in this Circular.
How will applications received by the Ministry of Health before January 1, 2022 be processed?
Continue to be processed according to the provisions of Circular No. 13/2021/TT-BYT.
When does this Circular take effect?
Takes effect from August 1, 2022.
When does Circular No. 13/2021/TT-BYT cease to be effective?
Ceases to be effective from the date this Circular takes effect.
Toàn văn
CIRCULAR
Regulations on the list and circulation number for medical equipment serving prevention and control of COVID-19 in emergency situations
Pursuant to Decree No. 75/2017/NĐ-CP dated October 27, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health; the 6 year of 2017 Cof the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on management of medical equipment;
On the proposal of the Director of the Department of Medical Equipment and Infrastructure;
The Minister of Health issues this Circular stipulating the list and circulation number for medical equipment serving prevention and control of COVID-19 in emergency situations.
Article 1. List of medical equipment serving prevention and control of COVID-19 in emergency situations as prescribed in Clause 3, Article 29 of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on management of medical equipment
1. PCR machine.
2. Chemicals (biological reagents) for running PCR tests for SARS-CoV-2.
3. Rapid antigen/antibody test kits for SARS-CoV-2.
4. High-function ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high-flow oxygen machines, portable ventilators.
5. Continuous renal replacement therapy machine.
6. Mobile X-ray machine.
7. Blood gas analyzer (capable of measuring electrolytes, lactate, hematocrit).
8. Patient monitor with ≥ 5 parameters.
9. Electric syringe pump; Infusion pump.
10. Defibrillator with pacing function.
11. Coagulation time measurement machine.
12. Hemodynamic monitoring machine.
Article 2. Supplementing the certificate of registration for circulation of medical equipment category C, D serving prevention and control of COVID-19 in emergency situations
Supplementing the model of the certificate of registration for circulation of medical equipment category C, D serving prevention and control of COVID-19 in emergency situations (as specified in Appendix I attached hereto).
Article 3. Effectiveness
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 stipulating circulation number and importation of medical equipment serving prevention and control of COVID-19 in emergency situations shall cease to be effective from the date this Circular takes effect.
Article 4. Transitional Provisions
Applications for certificates of registration for circulation of medical equipment category C, D serving prevention and control of COVID-19 that have been received by the Ministry of Health before January 1, 2022 shall continue to be processed according to the provisions of Circular No. 13/2021/TT-BYT dated September 16, 2021 of the Minister of Health stipulating circulation number and importation of medical equipment serving prevention and control of COVID-19 in emergency situations.
State-owned enterprises that have been assigned by the Ministry of Agriculture and Rural Development to conduct offshore wind power project surveys before the effective date of this Circular shall continue to implement according to the assigned documents; any new matters arising after the effective date of this Circular shall be implemented in accordance with the provisions of this Circular.
The Head of the Ministry's Office; the Inspector General of the Ministry; Directors of Departments, Heads of Bureaus, Directors of General Departments under the Ministry of Health; Directors of Provincial Health Services and relevant agencies, organizations, and individuals are responsible for implementing this Circular. In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly report to the Ministry of Health for consideration and resolution.
In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly report to the Ministry of Health for consideration and resolution./.
DEPUTY MINISTER
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