Circular No. 10/2023/TT-BYT amends and supplements certain provisions of Circular No. 19/2021/TT-BYT regarding model documents and reports implementing Decree No. 98/2021/NĐ-CP on medical equipment management. This document specifies the amendments and supplements to related forms concerning medical equipment management.
Scope of application
Organizations and individuals in the healthcare sector involved in medical equipment management
Key points
- Amend and supplement certain model documents and reports as specified in Appendix I (Form No. 02.01; Form No. 02.02; Form No. 03.01; Form No. 03.02; Form No. 03.03; Form No. 03.04 and Form No. 03.05) (Article 1, Clause 1)
- Add new model documents such as Form No. 05.A and Form No. 05.B in Appendix I and IV (Article 1, Clauses 1b and 2b)
- Amend and supplement other forms as specified in Appendix IV (Form No. 02.01; Form No. 02.02; Form No. 03; Form No. 05 and Form No. 07) (Article 1, Clause 2a)
- Add a power of attorney form for issuing import permits for medical equipment as specified in Appendix VI.A (Article 1, Clause 3)
- Amend and supplement other model documents as specified in Appendix VIII (Form No. 04) and add Form No. 06 (Article 1, Clause 4)
🌐 Social impact of this document
- Enhance the strictness of medical equipment management through updating model documents and reports
- Contribute to improving healthcare service quality by ensuring the accuracy and completeness of records related to medical equipment
- Create initial difficulties for organizations and individuals who have not yet updated new document models
❓ Frequently asked questions
When does this Circular take effect?
This Circular takes effect from the date of issuance.
Can old forms submitted before this Circular takes effect continue to be used?
Yes, except in cases where the file requires amendments or supplements (Article 2, Clause 1).
Can power of attorney forms signed before this Circular takes effect continue to be used?
Continue to use them for submitting applications for import permits for medical equipment (Article 2, Clause 2).
What specific model documents does this Circular regulate?
Specifies amendments and supplements to models such as Form No. 02.01; Form No. 02.02; Form No. 03.01; Form No. 03.02; Form No. 03.03; Form No. 03.04 and Form No. 03.05 (Article 1, Clause 1).
What does this Circular stipulate regarding the power of attorney form?
Adds Appendix VI.A: Power of Attorney Form for Issuing Import Permits for Medical Equipment (Article 1, Clause 3).
Full text
CIRCULAR
AMENDING AND SUPPLEMENTING CERTAIN ARTICLES OF CIRCULAR NO. 19/2021/TT-BYT DATED OCTOBER 16, 2021 ISSUED BY THE MINISTER OF HEALTH ON SAMPLE DOCUMENTS AND REPORTS IMPLEMENTING GOVERNMENT DECREE NO. 98/2021/NĐ-CP DATED OCTOBER 8, 2021 REGARDING MEDICAL EQUIPMENT MANAGEMENT
Pursuant to Government Decree No. 95/2022/NĐ-CP dated November 15, 2022 on the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Government Decree No. 98/2021/NĐ-CP dated October 8, 2021 on medical equipment management;
Pursuant to Government Decree No. 07/2023/NĐ-CP dated March 3, 2023 amending and supplementing certain articles of Government Decree No. 98/2021/NĐ-CP dated October 8, 2021 on medical equipment management;
At the proposal of the Director of the Department of Medical Equipment and Health Facilities;
The Minister of Health issues this Circular amending and supplementing certain articles of Circular No. 19/2021/TT-BYT dated October 16, 2021 issued by the Minister of Health on sample documents and reports implementing Government Decree No. 98/2021/NĐ-CP dated October 8, 2021 on medical equipment management.
Article 1. Amending and supplementing Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 issued by the Minister of Health on sample documents and reports implementing Government Decree No. 98/2021/NĐ-CP dated October 8, 2021 on medical equipment management
1. Amending and supplementing Clause 1 of Article 3 as stipulated in Appendix I as follows:
a) Amending and supplementing Sample No. 02.01; Sample No. 02.02; Sample No. 03.01; Sample No. 03.02; Sample No. 03.03; Sample No. 03.04 and Sample No. 03.05.
b) Supplementing Sample No. 05.A and Sample No. 05.B.
2. Amending and supplementing Clause 4 of Article 3 as stipulated in Appendix IV as follows:
a) Amending and supplementing Sample No. 02.01; Sample No. 02.02; Sample No. 03; Sample No. 05 and Sample No. 07.
b) Supplementing Sample No. 05.A and Sample No. 05.B.
3. Supplementing Clause 6a of Article 3 as follows:
“Clause 6a: Appendix VI.A: Sample authorization letter for issuing import permits for medical equipment in accordance with Clause 18, Article 1 of Government Decree No. 07/2023/NĐ-CP.”
4. Amending and supplementing Clause 8 of Article 3 as stipulated in Appendix VIII as follows:
a) Amending and supplementing Sample No. 04.
b) Supplementing Sample No. 06.
Article 2. Transitional Provisions
1. Documents submitted in the standard application dossier or the registration permit application dossier or the import license application dossier before this Circular takes effect shall continue to be used for issuing circulation numbers and import licenses, except where the dossiers require amendments or supplements.
2. Power of attorney forms prescribed by the owner of medical devices signed and issued before this Circular takes effect may continue to be used to submit applications for medical device import permits.
Article 3. Implementation Provisions
1. This Circular shall take effect from the date of issuance.
2. During implementation, if there are difficulties or obstacles, organizations and individuals shall report them to the Ministry of Health for consideration and resolution./.
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