Vietnam Drafts Tighter Regulations on Medical Devices

Continuing to refine its nascent laws regulating the sale of medical devices and IVDs, Vietnam’s Ministry of Health in March drafted new legal parameters that tighten controls on classifying, testing, and conducting clinical trials of medical devices. As drafted, the new regulations would also increase government oversight of medical device clinical trials, registration, and advertisements, as well as the use of raw materials and narcotics in medical devices.