Healthcare Facility Licensing in Vietnam

Healthcare facility licensing in Vietnam — the regulation of who may establish and operate hospitals, clinics and other healthcare facilities — was substantially reshaped by Law 15/2023/QH15 and its implementing instruments effective 1 January 2024. The defining change is the abolition of the long-standing administrative hierarchy (hạng đặc biệt / I / II / III; tuyến trung ương / tỉnh / huyện / xã) for licensing purposes, replaced by a three-tier professional-technical level classification (cấp ban đầu, cấp cơ bản, cấp chuyên sâu) determined by clinical capacity, technical support, training and research — not by administrative position in the health system.

Scope of this page:

• The Giấy phép hoạt động khám bệnh, chữa bệnh (GPHĐ KCB) — what it is and who needs it.
• The new three-tier professional-technical level scheme and the 2024–2025 transition.
• Recognised facility types — hospitals, clinics, traditional-medicine facilities, commune health stations.
• Issuing authority split between Bộ Y tế and Sở Y tế.
• Personnel and leadership requirements.
• Quality accreditation under Circular 35/2024/TT-BYT and the legacy MOH quality criteria.
• Sanctions for operating without a licence.

What the GPHĐ KCB is: The GPHĐ KCB is the establishment-level operating licence that every facility delivering medical examination and treatment in Vietnam must hold. The licence specifies the facility type, the scope of medical activities authorised, the professional-technical level, and any specialty limitations. The GPHĐ KCB is open-ended in duration but subject to periodic inspection and quality assessment; it may be suspended or revoked for breach of operating conditions or for falling below the basic quality standards now mandated by Circular 35/2024/TT-BYT.

The new three-tier classification (from 1 January 2025): Under the 2024 reform, every licensed facility is classified into one of three professional-technical levels:

• Cấp ban đầu (initial level) — primary care: commune health stations, family-medicine clinics, basic outpatient facilities. Limited to defined first-contact services.
• Cấp cơ bản (basic level) — general hospitals and multi-specialty clinics providing the routine range of inpatient and outpatient services for the population.
• Cấp chuyên sâu (specialised level) — tertiary hospitals with advanced sub-specialty capacity, training and research function, complex surgery, organ transplantation, advanced diagnostic and therapeutic technologies.

Implementation: every existing licensed facility was required to self-score against the new technical-level criteria via chatluongbenhvien.vn by 25 October 2024 per Công văn 5845/BYT-KCB (2024). The new tiering took practical effect from 1 January 2025. Legacy hạng labels (hạng đặc biệt / I / II / III) continue to appear in some BHYT pricing and salary-grade contexts but are no longer the licensing classifier.

Recognised facility types under Law 15/2023:

• Bệnh viện (hospital) — general or specialty.
• Phòng khám đa khoa (multi-specialty clinic).
• Phòng khám chuyên khoa (single-specialty clinic).
• Phòng khám y học gia đình (family-medicine clinic).
• Phòng chẩn trị y học cổ truyền (traditional-medicine examination and treatment establishment).
• Nhà hộ sinh (maternity facility).
• Cơ sở dịch vụ cận lâm sàng (paraclinical/diagnostic service facility — imaging, laboratory).
• Cơ sở khám bệnh, chữa bệnh nhân đạo (charitable medical facility).
• Trạm y tế xã, phường, thị trấn (commune-, ward- and township-level health station — the primary-care base of the public system).
• Other facility types as defined by Decree 96/2023.

Issuing authority:

• Bộ Y tế (Cục Quản lý Khám, Chữa bệnh) issues the GPHĐ KCB for hospitals under direct MOH management, foreign-invested medical facilities, and facilities of central ministries (other than Defence and Public Security, which operate their own systems).
• Sở Y tế cấp tỉnh issues the GPHĐ KCB for all other facilities operating in the province — the majority pathway by volume, covering provincial hospitals, district hospitals, private hospitals, the full range of private clinics, and commune health stations.

Personnel and leadership requirements: Decree 96/2023/NĐ-CP sets minimum personnel requirements per facility type, including the qualifications of the người chịu trách nhiệm chuyên môn (responsible professional lead, equivalent to a clinical director). Generally:

• The responsible professional lead must hold a valid CCHN KCB in the appropriate specialty.
• Minimum 36 months of post-license practice in the specialty.
• Senior staff (heads of department, heads of clinical service) must hold the appropriate CCHN KCB scope.
• Minimum aggregate staffing per facility type is specified in the Decree's Annexes.

Quality accreditation:

• Circular 35/2024/TT-BYT (issued 16 November 2024) introduces basic quality standards (tiêu chuẩn chất lượng cơ bản) applied from 1 January 2025. Annual self-assessment against the basic standards is now a statutory requirement under Article 57 of Law 15/2023; falling below triggers corrective measures and may lead to GPHĐ KCB suspension.
• The Bộ tiêu chí chất lượng bệnh viện Việt Nam v2.0, issued by Decision 6858/QĐ-BYT (2016), remains in use for the annual MOH quality check; Decision 3652/QĐ-BYT (3 December 2024) issued the 2024–2025 implementation plan.
• No state-mandated equivalent of Joint Commission International (JCI) or ISO 9001 — these accreditation systems are voluntary and pursued by some private and foreign-invested hospitals for international branding.

Sanctions:

• Administrative — Decree 117/2020/NĐ-CP, as amended by Decree 124/2021/NĐ-CP, covers operating without a GPHĐ KCB, operating beyond the licensed scope, and below-standard quality. Penalties range from fines to suspension or revocation of the licence.
• Criminal — Penal Code Article 315 (medical-practice violations) can attach to facility operators in the case of aggravated breaches involving patient harm.

Foundational law:

• Law 15/2023/QH15 — Chương IV on healthcare facilities. Effective 1 January 2024.
• Law 112/2025/QH15 — terminology update, effective 1 March 2026.

Implementing decree:

• Decree 96/2023/NĐ-CP — Chương III on facility conditions, establishment, organisation, and the personnel matrix.

Implementing circulars:

• Circular 32/2023/TT-BYT — technical details for facility scope, signage, list of techniques.
• Circular 35/2024/TT-BYT — basic quality standards, applied from 1 January 2025.

Quality criteria:

• Bộ tiêu chí chất lượng bệnh viện Việt Nam v2.0 (Decision 6858/QĐ-BYT, 2016).
• Decision 3652/QĐ-BYT (3 December 2024) — 2024–2025 implementation plan for the annual MOH quality check.

Transition:

• Công văn 5845/BYT-KCB (2024) — self-scoring instruction for the new three-tier classification.

Sanctions:

• Decree 117/2020/NĐ-CP (amended by Decree 124/2021).
• Penal Code Article 315.

Law and decree:

• Law 15/2023/QH15 — https://vanban.chinhphu.vn/?pageid=27160&docid=207396
• Decree 96/2023/NĐ-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=209491

Circulars:

• Circular 32/2023/TT-BYT — https://thuvienphapluat.vn/van-ban/the-thao-y-te/circular-32-2023-tt-byt-elaboration-of-the-law-on-medical-examination-and-treatment-595654.aspx
• Circular 35/2024/TT-BYT (basic quality standards) — see thuvienphapluat.vn search.
• Công văn 5845/BYT-KCB 2024 — https://luatvietnam.vn/y-te/cong-van-5845-byt-kcb-2024-xep-cap-chuyen-mon-ky-thuat-co-so-kham-benh-chua-benh-366960-d6.html

Operational portals:

• Bộ Y tế — Cục Quản lý KCB — https://kcb.vn
• Hospital quality assessment — https://chatluongbenhvien.vn

Sanctions:

• Decree 117/2020/NĐ-CP — https://vanban.chinhphu.vn/default.aspx?pageid=27160&docid=201105

Medibase cross-references:

• Reference — Medical Practice Licensing — /practice/practice-licensing/
• Reference — Telemedicine — /practice/telemedicine/
• Reference — Traditional Medicine (phòng chẩn trị YHCT) — /medicine/traditional-medicine/

9 January 2023 — Law 15/2023/QH15 passed.

30 December 2023 — Decree 96/2023/NĐ-CP issued.

31 December 2023 — Circular 32/2023/TT-BYT issued.

1 January 2024 — Law 15/2023, Decree 96/2023, and Circular 32/2023 enter into force.

16 November 2024 — Circular 35/2024/TT-BYT (basic quality standards) issued.

25 October 2024 — Deadline for facilities to self-score against the new three-tier classification per Công văn 5845/BYT-KCB.

3 December 2024 — Decision 3652/QĐ-BYT issued the 2024–2025 implementation plan for the annual MOH quality check.

1 January 2025 — Circular 35/2024/TT-BYT basic quality standards apply; new three-tier professional-technical level classification takes practical effect.

1 March 2026 — Law 112/2025/QH15 terminology update effective.