From 11/5/2023, 19 forms on management of medical equipment in Vietnam shall be amended
From 11/5/2023, what forms on management of medical equipment in Vietnam shall be amended? - Question from Ms. Thuong (Ha Noi).
The Ministry of Health issued latest Circular amending a number of forms on management of medical equipment in Vietnam
On May 11, 2023, the Minister of Health issued the Circular 10/2023/TT-BYT amending Circular 19/2021/TT-BYT on forms and reports on the implementation of Decree 98/2021/NĐ-CP (management of medical equipment).
Circular 10/2023/TT-BYT has amended 19 forms related to the field of medical equipment management.
Circular 10/2023/TT-BYT takes effect from May 11, 2023.
What are principles of management of medical equipment in Vietnam?
Pursuant to Article 3 of the Decree 98/2021/NĐ-CP stipulating principles of management of medical equipment in Vietnam as follows:
- The quality, safety and efficacy of the medical device must be verified.
- Adequate, accurate and timely information about specifications and intended purpose of the medical device and potential risks to the user must be provided.
- The traceability of medical devices must be ensured.
- Medical devices shall be managed in accordance with risk classification rules and relevant national technical regulations and/or national standards issued or recognized by competent regulatory authorities or announced standards applied by organizations/individuals in accordance with regulations of law.
- Medical devices that are measuring devices or radiation equipment must be managed in accordance with regulations of the law on measurement, the law on atomic energy and regulations herein.
- Chemicals and preparations intended solely for disinfection of medical devices shall be managed in accordance with regulations herein. Chemicals and preparations intended for other purposes, in addition to the disinfection of medical devices, shall be managed in accordance with regulations of law on insecticidal and germicidal chemicals and preparations for medical and household use.
- Medical devices, raw materials or ingredients used for manufacturing of medical devices, and substances for external quality assessment that contain narcotic substances and precursors must be managed in accordance with regulations of law on drug control, if they are imported or exported, and regulations herein.
- Regulations on classification, issuance of registration number, and eligibility requirements for trading of medical devices laid down herein shall not apply to:
+ Software used for medical devices;
+ Medical devices that are traded as normal goods and imported as gifts or presents given to individuals or organizations other than health facilities.
From 11/5/2023, what forms on management of medical equipment in Vietnam shall be amended?
Pursuant to Article 1 of the Circular 10/2023/TT-BYT stipulating forms on management of medical equipment in Vietnam as follows:
Amending and supplementing Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health providing for the form of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 16, 2021. November 8, 2021 of the Government on medical equipment management
1. Amend and supplement Clause 1, Article 3 specified in Appendix I as follows:
a) Amend and supplement 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.
b) Add Form No. 05.A and Form No. 05.B.
2. Amend and supplement Clause 4, Article 3 specified in Appendix IV as follows:
a) Amend and supplement Form No. 02.01; Form No. 02.02; Form No. 03; Form No. 05 and Form No. 07.
b) Add Form No. 05.A and Form No. 05.B.
3. Add Clause 6a to Article 3 as follows:
“6a. Appendix VI.A: Form of authorization letter to grant import license for medical equipment as prescribed in Clause 18, Article 1 of Decree No. 07/2023/ND-CP.”
4. Amend and supplement Clause 8 Article 3 specified in Appendix VIII as follows:
a) Amend and supplement Form No. 04.
b) Add Form No. 06.
Thus, from May 11, 2023, the amended forms on medical equipment management are:
In Appendix I:
Form No. 02.01 Appendix I issued together with Circular 19/2021/TT-BYT: Form of declaration of applicable standards of medical equipment of class A.
Form No. 02.02 Appendix I issued together with Circular 19/2021/TT-BYT: Form of declaration of applicable standards of medical equipment of class B.
Form No. 03.01 Appendix I promulgated together with Circular 19/2021/TT-BYT: Form of request for new issuance of free-sale registration number of medical equipment of type C, D with national technical regulations.
Form No. 03.02 Appendix I issued together with Circular 19/2021/TT-BYT: sample of a written request for a new free-sale registration number for medical equipment of categories C and D which is a measuring instrument subject to sample approval.
Form No. 03.03 in Appendix I issued together with Circular 19/2021/TT-BYT: sample of a written request for a new free-sale registration number for medical equipment of categories C and D in the case of fast issuance.
Form No. 03.04 Appendix I promulgated together with Circular 19/2021/TT-BYT: sample of a written request for a new free-sale registration number of type C, D medical equipment in case of emergency.
Form No. 03.05 Appendix I promulgated together with Circular 19/2021/TT-BYT: sample of a written request for a new free-sale registration number of other medical equipment of categories C and D.
Form No. 05.A (additional) Appendix I issued together with Circular 10/2023/TT-BYT: Form of application form for a license to import medical equipment to comply with the provisions of Clause 18 of this Article. 1 Decree 07/2023/ND-CP.
Form No. 05.B (additional) Appendix I issued together with Circular 10/2023/TT-BYT: Order form for import of in vitro diagnostic biological products to comply with the provisions of Clause 18, Article 1 of Decree 07 2023/ND-CP.
In Appendix IV:
Form No. 02.01 Appendix IV issued together with Circular 19/2021/TT-BYT: sample information about application for publication of applicable standards of medical equipment of class A
Form No. 02.02: Appendix IV issued together with Circular 19/2021/TT-BYT: form of information on application for publication of applicable standards of medical equipment of type B
Form No. 03: Appendix IV issued together with Circular 19/2021/TT-BYT: Sample certificate of registration of circulation of medical equipment of categories C, D
Form No. 05: Appendix IV issued together with Circular 19/2021/TT-BYT: form of license to import medical equipment
Form No. 07: Appendix IV issued together with Circular 19/2021/TT-BYT: Sample certificate of free sale of medical equipment
Form No. 05.A (additional) Appendix IV issued together with Circular 19/2021/TT-BYT: Sample import license to comply with the provisions of Clause 18, Article 1 of Decree 07/2023/ND-CP .
Form No. 05.B (additional) Appendix IV issued together with Circular 19/2021/TT-BYT: Sample license to import in vitro diagnostic biological products to comply with the provisions of Clause 18, Article 1 of Decree 07 2023/ND-CP.
In Appendix VI.A:
Form of authorization letter to grant import license for medical equipment as prescribed in Clause 18, Article 1 of Decree 07/2023/ND-CP
In Appendix VIII:
Form No. 04, Appendix IV issued together with Circular 19/2021/TT-BYT: Form of document with brief technical description of imported medical equipment
Form No. 06 (additional) Appendix IV issued together with Circular 10/2023/TT-BYT: Form of technical document describing types of medical equipment imported for grant of import permits.
Best regards!
