Circular 29/2024/TT-BYT stipulates the economic and technical characteristics of medical devices subject to price declaration, issued by the Minister of Health.

✦ Tóm lược thông minh

This Circular stipulates the economic and technical characteristics of medical devices required for price declaration, including specific types and detailed names of each device. The document applies to organizations and individuals involved in managing and using medical devices.

Đối tượng áp dụng

Organizations and individuals in the healthcare sector; Infrastructure and Medical Equipment Department - Ministry of Health; National Health Information Center - Ministry of Health; People's Committees of provinces and centrally governed cities.

Các điểm cốt lõi

The economic and technical characteristics of medical devices subject to price declaration are specified in the Appendix attached to this Circular (Article 1).
The Infrastructure and Medical Equipment Department is responsible for announcing the forms of receiving price declaration documents for medical devices, reviewing lists of entities required to declare prices, and posting them on the Online Public Service System (Article 3.1).
The National Health Information Center is responsible for building an information technology system to implement price declarations for medical devices (Article 3.2).
People's Committees of provinces and centrally governed cities are responsible for organizing the implementation of receiving price declarations according to laws on pricing (Article 3.3).
The Infrastructure and Medical Equipment Department must review and compile the economic and technical characteristics of medical devices subject to price declaration at least once every two years to submit to the Ministry of Health for issuance of amendments and supplements to this Circular (Article 3.1d).

🌐 Tác động xã hội từ văn bản này

Strengthen state management over prices for medical devices to ensure transparency and fairness in price declarations.
Facilitate access to information about the economic and technical characteristics of medical devices required for price declaration for relevant organizations and individuals.
Challenges faced by units unfamiliar with new regulations on price declaration and updating appropriate information technology systems.

❓ Câu hỏi thường gặp

To whom does this Circular apply?

This Circular applies to organizations and individuals in the healthcare sector; Infrastructure and Medical Equipment Department - Ministry of Health; National Health Information Center - Ministry of Health; People's Committees of provinces and centrally governed cities.

Where are the economic and technical characteristics of medical devices specified?

The economic and technical characteristics of medical devices subject to price declaration are specified in detail in the Appendix attached to this Circular.

What responsibilities does the Infrastructure and Medical Equipment Department have?

The Infrastructure and Medical Equipment Department is responsible for announcing the forms of receiving price declaration documents for medical devices, reviewing lists of entities required to declare prices, and posting them on the Online Public Service System.

What role does the National Health Information Center play?

The National Health Information Center is responsible for leading the construction of an information technology system to implement price declarations for medical devices.

When does this Circular take effect?

This Circular takes effect from January 1, 2025.

Toàn văn

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
Number: 29/2024/TT-BYT	Hanoi, November 3, 2024

CIRCULAR

Regulations on economic and technical characteristics of medical devices subject to price declaration

Pursuant to the Law on Prices number 16/2023/QH15 dated June 19, 2023, adopted by the National Assembly;

Pursuant to the Government Decree number 85/2024/NĐ-CP dated July 10, 2024, detailing certain provisions of the Law on Prices; Pursuant to the Government Decree number 95/2022/NĐ-CP dated November 15, 2022, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Infrastructure and Medical Equipment Department,

The Minister of Health issues this Circular regulating the economic and technical characteristics of medical devices subject to price declaration.

Article 1. Economic and technical characteristics of medical devices subject to price declaration The economic and technical characteristics (detailed name, specific type) of medical devices subject to price declaration are set forth in the Appendix attached to this Circular.

1. The Infrastructure and Medical Equipment Department of the Ministry of Health shall be responsible for:

a) Announcing the form of acceptance and organizing the acceptance of price declaration documents for medical devices in accordance with the laws on prices;

Article 2. Effective Date

This Circular shall take effect from January 1, 2025.

Article 3. Implementation Organization

b) Reviewing and compiling a list of entities required to declare prices in accordance with the laws on prices and posting it on the online public service system for medical equipment management of the Ministry of Health;

c) Cooperating with the National Health Information Center of the Ministry of Health to build an information technology system for price declarations of medical devices;

d) Cooperating with relevant agencies of the Ministry of Finance to connect and update price declaration data of medical devices into the national price database in accordance with the laws on prices;

đ) Based on the requirements of state management on prices and the needs for price market analysis and forecasting, within a maximum period of two years, the Infrastructure and Medical Equipment Department shall take the lead and cooperate with related units to review, compile, and submit to the Ministry of Health for issuance of a Circular to amend, supplement, and update the economic and technical characteristics of medical devices subject to price declaration as prescribed.

2. The National Health Information Center of the Ministry of Health shall take the lead and cooperate with the Infrastructure and Medical Equipment Department to build an information technology system for price declarations of medical devices.

3. Provincial People's Committees directly under the central government shall be responsible for organizing the implementation of the acceptance of price declarations in accordance with the laws on prices to ensure convenience for organizations and individuals making declarations.

During the implementation process, if there are difficulties or obstacles, organizations and individuals should report them to the Ministry of Health (Infrastructure and Medical Equipment Department) for consideration and resolution./.

Place of receipt:

- Social Committee of the National Assembly;

- Office of the Government (Department of Legal Affairs, Official Gazette; Government Portal); - Minister (for reporting);
- Ministry of Justice (Office of Legal Document Supervision);
- Ministries, agencies at ministerial level, and agencies under the Government;
- People's Committees of provinces and centrally governed cities;
- Units under and affiliated with the Ministry of Health;
- Health sectors of ministries and agencies;
- Deputy Ministers of Health;
- Vietnam Medical Equipment Association;
- Health Departments of provinces and centrally governed cities;
- Ministry of Health Electronic Information Portal;
ECONOMIC AND TECHNICAL CHARACTERISTICS
OF MEDICAL DEVICES SUBJECT TO PRICE DECLARATION
(Issued together with Circular number 29/2024/TT-BYT dated November 3, 2024, issued by the Minister of Health)
- To be filed: VT, HTTB, PC.

DEPUTY MINISTER
DEPUTY MINISTER

(Signed)

Do Xuan Tuyen

ANNEX

SPECIFIC TYPES

DETAILED NAMES
Type Name

Medical Device Name (According to the registration number issued)		Artificial Kidney Machine
Section	Respirator	Serial number	High-Frequency Resuscitation Respirator for Children and Newborns
I	Respirator for Children and Newborns	1	Respirator for Children and Newborns
II	Neonatal Respirator	2	Neonatal Respirator
		3	Portable Respirator
		4	Non-Invasive Neonatal Respirator
		5	Anesthesia Machine
		6	Anesthesia Machine with Ventilation
		7	Anesthesia Machine with Ventilation Used in MRI Rooms
III	Patient Monitoring Machine	8	Patient Monitoring Machine
		9	Central Patient Monitoring Machine
		10	Electric Syringe Pump
IV	Electric Syringe Pump with Target Controlled Infusion (TCI) Function	11	Electric Syringe Pump with Target Controlled Infusion (TCI) Function
		12	Electric Syringe Pump for MRI Machines
V	Infusion Machine	13	Infusion Machine
		14	Defibrillator
		15	Automated External Defibrillator
VI	Automatic Defibrillator	16	Automatic Defibrillator
VII	Electrosurgical Knife	17	Electrosurgical Knife
		18	High-Frequency Electrosurgical Knife
		19	High-Frequency Electrosurgical Knife with Hemostasis Function
VIII	Plasma Electrosurgical Knife	20	Plasma Electrosurgical Knife
		21	Ultrasonic Electrosurgical Knife
		22	X-Ray System
		23	Dental and ENT CT X-Ray System
		24	Digital Radiography X-Ray System
IX	Dental X-Ray System	25	Fixed High-Frequency X-Ray System
		26	Diagnostic X-Ray System
		27	Digital Diagnostic X-Ray System
		28	Digital Fluoroscopy X-Ray System
		29	Mobile X-Ray System
		30	Two-Arm Suspended Robotic X-Ray System
		31	Digital X-Ray System
		32	Digital Radiography (DR) X-Ray System
		33	Digital Mammography X-Ray System
		34	Image Intensifier X-Ray System
		35	Portable X-Ray Machine
		36	Handheld X-Ray Machine
		37	Dental CT X-Ray Machine
		38	Mobile X-Ray Machine
		39	Digital Radiography X-Ray Machine
		40	Dental X-Ray Machine
		41	Image Intensifier X-Ray Machine
		42	High-Frequency X-Ray Machine
		43	C-Arm X-Ray Machine
		44	Portable C-Arm X-Ray Machine
		45	Digital Portable C-Arm X-Ray Machine
		46	Digital Mobile C-Arm X-Ray Machine
		47	Diagnostic X-Ray Machine
		48	Digital Diagnostic X-Ray Machine
		49	Digital Fluoroscopy X-Ray Machine
		50	Mammography X-Ray Machine
		51	Mobile X-Ray Machine
		52	High-Frequency Mobile X-Ray Machine
		53	Digital Mobile X-Ray Machine
		54	Digital X-Ray Machine
		55	Dental X-Ray Machine
		56	Panoramic Dental X-Ray Machine
		57	Total: 09 (nine) specific types and 60 (sixty) detailed names./.
		58	Dental X-ray machine
		59	Tooth X-ray machine
		60	Full-mouth dental X-ray machine

In total, there are 09 (nine) specific types and 60 (sixty) detailed names./.

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Căn cứ 3

16/2023/QH15 Luật Giá số 16/2023/QH15 Còn hiệu lực 85/2024/NĐ-CP Nghị định số 85/2024/NĐ-CP quy định chi tiết một số điều của Luật Giá Còn hiệu lực 95/2022/NĐ-CP Nghị định số 95/2022/NĐ-CP quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế Hết hiệu lực

29/2024/TT-BYT

Circular 29/2024/TT-BYT stipulates the economic and technical characteristics of medical devices subject to price declaration, issued by the Minister of Health.

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Tiếng Việt Thông tư 29/2024/TT-BYT quy định đặc điểm kinh tế - kỹ thuật của thiết bị y tế thực hiện kê khai giá do Bộ trưởng Bộ Y tế ban hành 한국어 시범규칙 29/2024/TT-BYT는 의료기기 가격신고에 필요한 경제-기술적 특징을 규정하며, 보건복지부 장관이 발포한 것임. 中文通知29/2024/TT-BYT规定了需要申报价格的医疗器械的经济和技术特征，由卫生部部长发布。

Circular 29/2024/TT-BYT stipulates the economic and technical characteristics of medical devices subject to price declaration, issued by the Minister of Health.

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