Although underdeveloped, the healthcare sector in Vietnam is rapidly expanding. The Vietnamese government has pledged about VND 46 trillion (US$2.2 billion) to improve and build more specialty hospitals and provincial-level general hospitals in less developed regions by 2013. In 2010, the Vietnamese medical device market was estimated at US$515 million. It is expected that the device market will continue to expand at about 15% a year. Some experts believe that the Vietnamese market will surpass US$1 billion in six more years.
The Vietnamese healthcare system needs a wide variety of medical devices, especially in the cardiovascular, liver cancer, diabetes, and orthopedic areas. The best sales prospects for this market include imaging diagnostic equipment (i.e., X-ray machines, CT Scanners, Color Ultrasound machines, Magnetic Resonance Imaging machines), operating theaters, sterilizing equipment, patient monitoring equipment and emergency equipment.
In Vietnam, the Ministry of Health (MOH) oversees medical device regulations. Within the MOH, the Department of Medical Equipment and Health Works (DMEHW) regulates medical devices. An important fact about medical device registration in Vietnam is that the basic process is different for imported devices than for domestically manufactured devices. Technically, imported devices do not need product registration at all, just an import license. Domestic devices, on the other hand, do generally require product registration and must be renewed.
The dossier for new import licenses includes documents such as the original catalog, product use instructions and technical specifications, quality control certificates, and the permit for product free sales certificate in the manufacturing country.