Medical device registration service is a solution that supports businesses in completing all legal documents and procedures required for their products to be legally authorized for circulation in the market. The service includes device classification consulting, preparation of technical documentation, declaration of applicable standards, and coordination with regulatory authorities, helping to reduce processing time while ensuring full compliance with current regulations.

Medical device classification is the process of determining the risk level of a medical device based on its intended use and the potential impact on patient health. In Vietnam, medical devices are typically classified into four groups: Class A (low risk): Simple devices with minimal impact on the body (e.g., bandages, medical gloves). Class B (low to moderate risk): Devices with limited interaction or intervention (e.g., basic blood pressure monitors). Class C (moderate to high risk): Devices used for important diagnostic or therapeutic purposes (e.g., ultrasound machines). Class D (high risk): Devices that directly affect life-support or involve invasive use (e.g., ventilators, implantable devices). Accurate classification is a crucial first step in the medical device registration process, as it determines the required regulatory pathway and documentation.    

Technical document translation refers to the process of translating specialized documents that contain technical, scientific, or industry-specific content while ensuring accuracy, consistency, and correct use of terminology. In the context of medical devices, this service typically includes translating user manuals, technical specifications, certificates, clinical documents, and regulatory files, ensuring they meet the requirements of regulatory authorities and maintain their original meaning and precision.