Opening a private medical laboratory is not as simple as renting premises and buying equipment: it is a medical examination and treatment facility that must hold an operating license and meet detailed conditions on laboratory floor area (minimum 10–20 m² depending on scope), biosafety and professional personnel under Decree 96/2023/ND-CP.
This article systematizes the operating-license requirements for private medical laboratories under current law.
1. Applicable legal framework
- Law on Medical Examination and Treatment 2023 (15/2023/QH15): laboratories are medical facilities operating under a license;
- Decree 96/2023/ND-CP: Article 40 (general licensing conditions), Article 53 (specific conditions for paraclinical service facilities — laboratories);
- Decree 103/2016/ND-CP: biosafety-standard certification for laboratories.
2. General conditions (Article 40, Decree 96/2023)
Before the specific conditions, a laboratory must satisfy the general conditions for all medical facilities:
- Premises: fixed location; structural safety, fire prevention, infection control, environmental protection, radiation safety (if applicable); adequate electricity and water; signage, diagrams and directions;
- Medical equipment: consistent with the registered list of professional techniques and scope of operation;
- Personnel: sufficient practitioners for the scale; a person in charge of professional techniques who practices full-time at the facility with at least 36 months of practice in the relevant scope.
3. Specific premises conditions (Article 53)
This is what fundamentally distinguishes a laboratory from an ordinary clinic:
- Waiting area for sample collection, sample reception area, and instrument-cleaning area;
- Minimum floor area by testing scope: 10 m² for 1 of 4 groups (hematology, biochemistry, medical genetics, immunology); 15 m² for 2–3 groups; 20 m² for all 4 groups;
- Anatomical pathology–cytology and microbiology testing: minimum 20 m² rooms, separate from other testing rooms;
- Walls of waterproof material up to the ceiling; floors waterproof, flat, with no water pooling.
4. Biosafety conditions
The laboratory must hold a Certificate of biosafety-standard compliance matching the biosafety level of its tests (Decree 103/2016/ND-CP). Issuance, re-issuance, self-declaration and revocation procedures for this certificate remain effective until 30/6/2027 under Decree 165/2026/ND-CP. Many investors overlook this while focusing only on the operating license.
5. Dossier and licensing procedure
- File the dossier with the Department of Health where the facility is located;
- The competent authority conducts an on-site appraisal before licensing — inspectors verify each condition on area, equipment, personnel and biosafety;
- The operating license is granted only when all conditions are met; operating without one incurs administrative sanctions and forced closure.
6. Common mistakes
- Renting premises too small for the minimum area of the registered scope;
- Combining microbiology with hematology/biochemistry rooms — the law requires separation;
- Forgetting the biosafety certificate;
- The professional lead lacking 36 months of relevant experience or not working full-time.
Planning a private laboratory and need a licensing-conditions review? Contact us for advice.
This article was prepared by the FLAW AI Legal Council. It is pending QA Council review and owner approval before publication. The information is for reference only and does not replace legal advice for your specific case.