Descriptions of non-in vitro medical equipment in Vietnam

Descriptions of non-in vitro medical equipment in Vietnam 

(1) Description and presentation of features of medical devices 

* Required contents: 

- Detailed descriptions of features of medical devices. 

- Descriptions of components and accessories used for the operation and packaging of devices. 

- Comprehensive descriptions of each functional component, material, or ingredient of medical devices, enclosed with representative images of medical devices in the form of diagrams, photos, or drawings if appropriate.

* Assessment guidelines: 

- Detailed descriptions of features of medical devices for the explanation of the operational principles of such medical devices and fundamental scientific terms forming the basic principles of medical devices. 

- Descriptions of components and accessories used for the operations and packaging of devices, including designed configurations and functions of components.

- Comprehensive descriptions of each functional competent, material, or ingredient of medical devices, enclosed with representative images of such medical devices in the form of diagrams, photos, or drawings if appropriate.

* Proving documents: 

- Documents on detailed descriptions of medical devices. 

- Technical documents issued by owners. 

(2) Instructions

* Required contents: 

Provision of information on instructions from product owners.

* Assessment guidelines: 

Necessary information provided by product owners includes summaries of procedures, measures, frequencies, time, quantity, and preparation requiring compliance for the safe use of medical devices. 

* Proving documents: 

- Detailed descriptions of medical devices (if any) or original instructions issued by owners of medical devices (enclosed with Vietnamese translation).

- Technical documents issued by owners. 

See more details in Decision No. 166/QD-BYT, effective as of January 22, 2024. 

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE