Uso previsto e indicación de uso en el registro chino de dispositivos médicos.
1. International Definitions
Across international regulatory frameworks, two key terms help define a medical device’s scope and safe application:
- Instrucciones de uso (IFU): Información proporcionada por el fabricante para informar al usuario del dispositivo sobre su finalidad, su correcto funcionamiento y las precauciones necesarias.
- Intended Purpose (Intended Use): The use for which the device is designed, as indicated by the manufacturer in labeling, IFU, and promotional materials.
These definitions are harmonized in global regulatory standards (e.g., ISO 13485, MDR in the EU) and form the foundation for technical documentation.
2. Requisitos reglamentarios chinos
En la Guía de Revisión Técnica para el Registro de Dispositivos Médicos de China (CH2.5), los conceptos de "uso previsto" e "indicación de uso" se abordan en detalle.
CH2.5.1 Ámbito de aplicación
Manufacturers must clearly describe:
- Therapeutic/diagnostic function and relevant medical process (e.g., IVD, rehabilitation, contraception, disinfection).
- Targeted disease/condition for diagnosis, treatment, prevention, alleviation, or cure.
- Parámetros de monitorización y consideraciones relacionadas.
- Requisitos del usuario previsto (habilidades/conocimientos/formación).
- Single-use vs. reusable characteristics.
- Combination with other products needed for intended use.
In addition, target patient population must be specified (e.g., adults, neonates, children, or general populations) along with relevant inclusion criteria and monitored parameters.
CH2.5.2 预期使用环境 (Intended Use Environment/Installation Requirements)
La documentación debe identificar la ubicación prevista (hospital, laboratorio, ambulancia, domicilio, etc.) y las condiciones ambientales (temperatura, humedad, presión, vibración, altitud) que puedan afectar al rendimiento.
CH2.5.3 儿童使用相关说明 (Use in Children)
If neonates, infants, or children are among the target population, specific usage and clinical context must be described.
CH2.5.4 Contraindicaciones
Where applicable, contraindications should be included, particularly for vulnerable groups (e.g., elderly, pregnant women, patients with renal/hepatic impairment).
(Reference: AnyTesting article)
3. Consideraciones prácticas para los fabricantes
In practice, China requires submission of both intended use and scope of application, which overlap with the internationally understood concept of “indication for use.”
- Indication for Use in China (Chapter 1.4 of product certificate): This section effectively carries the same meaning as intended use.
- Wording Advantage: If a manufacturer wants to emphasize specific claims in “indication for use,” these must align with Chapter 1.4, since regulators consider them interchangeable.
4. Take-Home Message
The terms intended use and indication for use are closely related internationally and in China. In Chinese device registration, indication for use (Chapter 1.4) is essentially treated as intended use. To avoid confusion and potential regulatory rejection, manufacturers should carefully align the language across all documents—labeling, IFU, promotional materials, and technical files.
👉 Si un fabricante desea destacar afirmaciones específicas en el apartado “Indicación de uso”, deberá adaptarlas de forma coherente al Capítulo 1.4 del certificado del producto.
