Healthcare & Medical Legal Services

Why is healthcare law complex?

Healthcare demand in Vietnam is rising fast with incomes and population ageing, drawing investment waves into private hospitals, clinics, pharmacy chains, pharmaceuticals, medical devices, cosmetics and digital health. It is also a sector the State manages with particular strictness: almost every activity attaches to a licence or notification procedure, administered by different authorities and sequenced interdependently. Missing any link can stall the project — or draw penalties once operating.

Legal map by sub-sector

1. Medical examination and treatment: hospitals, clinics

The framework is the Law on Medical Examination and Treatment 2023 (15/2023/QH15, effective 01/01/2024), with two parallel licence layers:

• Operation licence: new issuance conditions include lawful establishment; suitable physical facilities and medical equipment; IT infrastructure connected to the sector’s management system; sufficient practitioners; one person professionally in charge (Article 52). Authority: the Ministry of Health or the provincial health specialised agency (Article 51).
• Practice licences of each professional: doctors, nurses and other titles must all hold valid licences. Foreign specialists may be considered for recognition of foreign practice licences if recognised under an international treaty to which Vietnam is a party (or the issuing authority is assessed and recognised by the Ministry of Health), still valid and with an equivalent title to Article 26 (Article 29).

2. Pharmaceuticals: manufacturing, import, distribution, retail

The framework is the Pharmacy Law 2016 as amended by Law No. 44/2024/QH15 (effective 01/7/2025). Key points:

• Marketing registration is mandatory before drugs reach the market (under Circular 12/2025/TT-BYT); the amending law prioritises procedures for new drugs, rare drugs and vaccines.
• For the first time there is a corridor for pharmacy chains and pharmaceutical e-commerce — alongside newly prohibited acts, including online retail of certain drug categories.
• Drug manufacturing, import/export, wholesale and retail establishments must all meet conditions on facilities, personnel with pharmacy practice certificates and good practices (GMP, GSP, GDP).

3. Medical devices: classification and circulation numbers

Under Decree 98/2021/ND-CP (effective 01/01/2022), medical devices are classified by risk level from A (low) to D (high): types A and B undergo standard publication at the Department of Health (the publication number is the circulation number); types C and D require circulation registration. Circulation numbers are valid indefinitely (Article 21). Wrong classification is a common reason dossiers are returned.

4. Cosmetics: notification before circulation

Under Circular 06/2011/TT-BYT, cosmetics may only circulate after being granted a notification receipt number; the organisation placing the product on the market is responsible for safety, efficacy and quality (post-inspection). Dossiers go to the Drug Administration (imports) or the Department of Health (domestic manufacturing); receipt numbers are valid 05 years. The cosmetics–pharmaceuticals boundary must be drawn correctly from the start: products claiming “therapeutic” effects may be treated as drugs.

5. Digital health and healthcare: data and advertising

Digital health (telemedicine, electronic health records, appointment platforms) carries two additional regulatory layers:

• Health data is sensitive personal data: obligations on consent, impact assessment, protection measures and restrictions on cross-border transfer. See Cross-border personal data transfer and Personal data processing impact assessment.
• Advertising is tightly controlled: prescription drugs are banned from advertising (Article 7 of the Advertising Law 2012); health protection foods must register content before advertising, must carry the warning “This food is not medicine and does not replace medicinal treatment”, and may not use doctors’ images or patients’ thank-you letters (Decree 15/2018/ND-CP).

What should foreign investors note?

Healthcare is a conditional market-access sector for foreign investors: before choosing the investment form — greenfield, joint venture or acquisition — the applicable condition group, permitted ownership ratios and additional conditions on capital and personnel must be determined (Market access conditions for foreign investors).

For M&A, legal due diligence matters even more: the operation licence, professionals’ practice licences, health insurance contracts, tax obligations and pending patient complaints all “travel with” the facility to the new owner (Corporate legal due diligence, M&A and corporate restructuring).

How does FLAT LAW FIRM support?

• Investment structuring: choosing the presence form, assessing market access conditions, building the overall licensing roadmap.
• Licences and product notifications: preparing dossiers and representing procedures for operation licences, drug marketing registration, medical device publication/circulation registration, cosmetics notification.
• Medical personnel: recognition of practice licences for foreign specialists, work permits, labour contracts and internal rules for healthcare facilities.
• Operating compliance: pre-release advertising review, health data protection policies, supplier and health insurance contracts, tax obligations.
• Healthcare M&A: comprehensive legal due diligence of healthcare facilities, pharmacy chains, pharmaceutical companies — from licences and practising personnel to financial obligations and disputes.
• Disputes: working with regulators during inspections and penalties; handling patient complaints, commercial disputes and debts.

Implementation process

1. Receiving project information — mapping the required licences and implementation sequence.
2. Reviewing legal conditions: market access (with foreign elements), facilities, personnel, sector-specific requirements.
3. Preparing and filing dossiers at competent authorities; monitoring and handling supplementation requests and explanations.
4. Completing operating compliance: contracts, advertising, data protection, periodic post-licensing reports.
5. Long-term accompaniment: retainer advice, legal updates, expansion or restructuring support.

Legal updates as of September 2026

The Law on Medical Examination and Treatment 2023 (15/2023/QH15, effective 01/01/2024): shifting from “certificates” to “practice licences”; recognition of foreign practice licences (Article 29); new operation licence conditions tied to IT infrastructure (Article 52).

The Law amending the Pharmacy Law (44/2024/QH15, effective 01/7/2025): corridors for pharmacy chains and pharmaceutical e-commerce; prioritised procedures for new drugs, rare drugs and vaccines; marketing registration under Circular 12/2025/TT-BYT.

Medical devices under Decree 98/2021/ND-CP (effective 01/01/2022): A–D risk classification; A and B published at the Department of Health; C and D registered for circulation; indefinite circulation numbers (Article 21). Full texts at the Government’s legal normative document system.

Why choose FLAT LAW FIRM?

In healthcare, legal mistakes are paid for in downtime. FLAT LAW FIRM works on the principle of “licence map first, dossiers after” — listing all licences, notifications and procedures the project needs, sequencing them correctly and flagging time bottlenecks. The team has hands-on experience from sector dossiers, working in Vietnamese, Chinese and English (Chinese investors, Foreign investment in Vietnam).

Frequently asked questions

Useful links

You should talk to a lawyer if:

• You are preparing to open a hospital or clinic — needing a licence map and procedure roadmap before signing the premises lease.
• You are recruiting foreign doctors and medical specialists — needing practice licence recognition and work permits.
• You are preparing to import or distribute drugs, medical devices or cosmetics — needing correct classification and registration/notification procedures.
• You operate a digital health platform collecting user data — needing sensitive data protection review.
• You are preparing to advertise OTC drugs, health protection foods or medical services — needing content checks before release.
• You are considering acquiring a healthcare facility, pharmacy chain or pharmaceutical company — needing comprehensive legal due diligence before signing.