EXPORTING MEDICAL DEVICES INTO VIETNAM
Download 1. Overview Medical equipment is specified in Article 2, Decree 98/2021/ND-CP, as follows: 1.“medical device” means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements: a) The device is intended by the product owner to be used, whether separately or in combination with each other, for human beings for one or more of the following purposes: - diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma; - investigation, replacement, modification or support of the anatomy or of a physiological process; - supporting or sustaining life; - control of conception, - disinfection of medical devices; - providing information serving diagnosis, monitoring...
Continue reading