Circular No. 12/2026/TT-BYT on the List of congenital diseases requiring prenatal and neonatal screening

CIRCULAR

ON THE LIST OF CONGENITAL DISEASES REQUIRING PRENATAL AND NEONATAL SCREENING

Pursuant to the Law on Population No. 113/2025/QH15;

Pursuant to the Law on Medical Examination and Treatment No. 15/2023/QH15;

Pursuant to Decree No. 42/2025/ND-CP dated February 27, 2025 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;

At the request of the Director General of the Vietnam Population Authority;

The Minister of Health promulgates the Circular on the List of congenital diseases requiring prenatal and neonatal screening.

Article 1. The List of congenital diseases recommended for prenatal and neonatal screening

The List of congenital diseases recommended for prenatal screening prescribed in Appendix I and the List of congenital diseases recommended for neonatal screening prescribed in Appendix II are attached to this Circular to elaborate clause 1, Article 21 of the Law on Population.

Article 2. Definitions

Congenital disease means structural or functional abnormalities (including metabolic disorders) that occur during the fetal period and have adverse effects on an individual’s health.

Article 3. Principles for development of the List of congenital diseases

The selection of congenital diseases for the List shall comply with the following principles:

1. Prevalence and disease burden:

a) Congenital diseases with a high prevalence or high frequency of gene mutations in the population, or those causing severe consequences for a child’s health, physical condition and intellectual development;

b) Congenital diseases with high mortality rates in children or those causing lifelong disabilities and affecting the quality of the population.

2. Screening and diagnostic capacity:

a) There are appropriate, safe and easy-to-implement screening methods;

b) There are diagnostic methods or techniques to confirm the disease after screening results are obtained.

3. Feasibility and socio-economic effectiveness:

a) Compatible with the capacity of Vietnam’s healthcare system in terms of equipment and human resources;

b) Screening costs are appropriate for the financial capacity of the population, the state budget, or health insurance;

c) The socio-economic benefits gained from early detection, treatment and intervention are greater than those obtained from late detection.

Article 4. Effect

This Circular comes into force from July 01, 2026.

Article 5. Implementation

1. The Vietnam Population Authority shall:

a) Take charge and cooperate with relevant units in providing guidelines, directing and inspecting the implementation of this Circular nationwide;

b) Every two years, or when there are professional, technical or legal requirements, the Vietnam Population Authority shall take charge in reviewing and proposing amendments to the List attached to this Circular;

c) Take charge and cooperate with the Administration of Maternal and Children’s Affairs, the Department of Medical Service Administration and relevant units in developing, updating and proposing competent authorities for issuance of technical procedures and guidelines on prenatal and neonatal screening, diagnosis and treatment in accordance with the Law on Medical Examination and Treatment;

d) Publish the List of congenital diseases recommended for prenatal and neonatal screening on the electronic information portal of the Vietnam Population Authority and the electronic information portal of the Ministry of Health.

2. The Administration of Maternal and Children’s Affairs shall cooperate with the Vietnam Population Authority, the Department of Medical Service Administration and relevant units in developing, updating and proposing competent authorities for issuance of technical procedures and guidelines on prenatal and neonatal screening, diagnosis and treatment in accordance with the Law on Medical Examination and Treatment.

3. The Department of Medical Service Administration shall cooperate with the Vietnam Population Authority, the Administration of Maternal and Children’s Affairs and relevant units in developing, updating and proposing competent authorities for issuance of technical procedures and guidelines on prenatal and neonatal screening, diagnosis and treatment in accordance with the Law on Medical Examination and Treatment.

4. Health authorities under province-level People’s Committees shall:

a) Take charge and organize the implementation of this Circular;

b) Within their authority, direct, or review and advise competent authorities on investing in facilities, equipment and human resource training for medical examination and treatment establishments under their management to ensure sufficient capacity for implementing prenatal and neonatal screening;

c) Disseminate information and promote communication so that the public understands and voluntarily participates in prenatal and neonatal screening for congenital diseases.

5. Medical examination and treatment establishments shall:

a) Provide counseling and screening for congenital diseases during the prenatal and neonatal stages in accordance with professional procedures issued by the Ministry of Health. The diagnosis and treatment of congenital diseases in the prenatal and neonatal stages comply with the Law on Medical Examination and Treatment;

b) Regional prenatal and neonatal screening and diagnostic centers shall perform assigned functions and tasks, and shall be responsible for relevant affairs in provinces and cities as assigned by the Minister of Health.

Authorities, organizations and individuals shall report any issues during the implementation to the Ministry of Health (Vietnam Population Authority) for guidelines and resolution./.

APPENDIX I

THE LIST OF CONGENITAL DISEASES RECOMMENDED FOR PRENATAL SCREENING
(Attached to Circular No. 12 /2026/TT-BYT dated May 15, 2026 of the Minister of Health)

APPENDIX II

THE LIST OF CONGENITAL DISEASES RECOMMENDED FOR NEONATAL SCREENING
(Attached to Circular No. 12 /2026/TT-BYT dated May 15, 2026 of the Minister of Health)

A. Basic congenital disorders recommended for screening without the use of dried blood spots (DBS) on filter paper

B. List of congenital disorders recommended for screening using dried blood spot (DBS) specimens on filter paper