Recently, Vietnam’s Ministry of Health officially issued a unified general naming specification for medical devices, clarifying naming principles, prohibited terms, terminology usage rules, and a large number of positive and negative examples. Failure to comply with the new product naming requirements will directly result in supplementary registration corrections, review delays, and even barriers to market launch.
The Vietnamese name of a medical device must match the actual attributes and clinical intended use of the device, and shall be clearly distinguishable from ordinary commercial goods.
Non-compliant example: Dây dẫn (Guidewire)
Compliant name: Dây dẫn dùng trong can thiệp tim mạch (Guidewire for cardiovascular intervention)
Simply put: Do not only state the broad category. It must reflect the medical application scenario of the product, without stacking redundant modifiers.
| Prohibited Content in Product Names | Negative Example | Compliant Name |
|---|---|---|
| Color | 0.5 mm blue surgical suture | Surgical suture |
| Technical parameters | 128–256 slice CT scanning system | Computed tomography scanning system |
| Brand names, non-generic English proper nouns | IntellaNav Cardiac Electrophysiology Ablation Catheter | Cardiac Electrophysiology Ablation Catheter |
| Technical marketing concepts (proprietary technology) | EDOF technology intraocular lens | Intraocular lens |
| Advertising and promotional wording | Intelligent multi-function X-ray machine | X-ray machine |
| Non-scientific / non-clinical conceptual claims | Cancer treatment ultrasound equipment | Ultrasound equipment |
| Exaggerated therapeutic effects, claims of universal cure | Skin rejuvenation, whitening & anti-aging therapeutic laser device | Laser device for dermatological treatment |
| Generalized descriptions such as "various types", "multiple sizes" | Multi-specification spinal screw | Spinal screw |
Tips:
Model numbers, parameters, colors and brands may be placed in the model field, labels or other sections of the instructions for use, and must not be included in the generic product name.
Generic device names shall normally be written in Vietnamese in lowercase, not all caps.
Commercial names, manufacturer names, product codes and model numbers shall not be mixed into the generic name. Multiple medical device names cannot be combined into one.
English terms are generally prohibited unless the term cannot be translated into Vietnamese or is widely accepted in professional fields (e.g. Catheter).
| Non-compliant Name (Prohibited) | New Compliant Vietnamese Name | Chinese Definition |
|---|---|---|
| Metal embolization coil system | Bộ Coil nút mạch bằng kim loại | Metal Embolization Coil Kit |
| Artificial hip joint system | Bộ khớp háng nhân tạo | Artificial Hip Joint Kit |
| CT-Scanner 256-slice system | Hệ thống chụp cắt lớp vi tính | Computed Tomography Scanning System |
| Advanced / High-Frequency Ventilator | Máy thở | Ventilator |
| CPAP/BiPAP Respiratory Resuscitator | Máy thở không xâm nhập | Non-invasive Ventilator |
| INTERGARD Silver-Coated Artificial Vessel | Mạch máu nhân tạo phủ bạc | Silver-Coated Artificial Blood Vessel |
| Dialysate Filter | Quả lọc dịch cho chạy thận nhân tạo | Dialysate Filter for Hemodialysis |
Product identity information in Vietnam application forms, CSDT and supporting documents shall remain consistent or clearly traceable. Generic name, commercial name, main model and product code shall be declared in separate corresponding fields and shall not be confused.
Draft the Vietnamese product name in advance in accordance with Annex II, and have it reviewed by medical translators familiar with Vietnam medical device regulations.
Do not simply rely on machine translation. Brand / commercial name corresponds to Tên thương mại; main model / product family corresponds to Chủng loại; product code has a separate field Mã sản phẩm. Specifications, dimensions, colors etc. shall be placed in corresponding model numbers, codes, labels or technical documentation as appropriate.
For drug-coated and MRI-compatible products, add the required descriptions strictly following the rules and do not omit any content.
Common consequences of non-compliant naming:
