Vietnam Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-24-2011, 23:54 PM

General Market Condition: Restricted
The Government has recognized that neither the State budget nor even the largesse of official development assistance (ODA) donors can cope with Vietnam's needs for investment in health care facilities, and over the past few years has promulgated measures to encourage private investment in this sector, which was previously reserved for the State. Although private hospitals only serve a limited market of wealthier Vietnamese and some foreign nationals, the number of private hospitals grew from 6 in 1999 to 10 in 2000, each with around US$2 miilion in invested capital. Private hospitals are more open to purchasing new equipment and employing advanced techniques that will allow them to differentiate themselves in the market.
Supplementing hospitals, the system also has 19,836 private health care clinics (many run as 'sidelines' by staff doctors from State-owned hospitals), 7,015 traditional medicine centers, 3,432 specialized clinics, and 550 family-run clinics. These establishments are predominately small-scale and are not likely to procure much high-end equipment. However, they may represent a market for used equipment with service and warranty.
Regarding used equipment, Decision 2019/1997/QD-BKHCNMT dated December 1, 1997, stipulates that the Ministry of Science, Technology, and Environment (MOSTE) must inspect imported used medical equipment. Imported used medical equipment must retain at least 80 percent of its life expectancy and must not consume more than 10 percent of fuels or electricity used by newer versions of the equipment.
Import Climate
Importation of medical equipment into Vietnam must go through a trading company that has an import license. In the past, only state-own enterprises had licenses to import medical equipment to Vietnam, and these trading companies charged the real equipment buyers or distributors a few percent commission rate on the total value of the imported goods. Now, any business entity, including foreign invested enterprises that have a legally registered business license, can be engaged in direct import and export activities.
Decree 11/1999/ND-CP issued on 3 March 1999 stipulates the ban of medical equipment. Only medical equipment intended for sex enhancement and aphrodisiac purposes have been clearly identified as banned medical equipment. Decision 088/2000/QD/BTM issued 18/2/2000 provides further detailed instructions and a list of banned medical equipment.
According to the Government's Decree 89/CP promulgated on 12 December 1995, each year the Ministry of Health, in consultation with the Ministry of Trade, issues a list of equipment in which importation must be registered and approved by the Ministry of Health. Decree 89/CP has been altered many times and importation of medical equipment is now regulated by Decision 242/1999/QD/TTg issued on 30 December 1999. Decree 89/CP is now replaced by Circular 05/2000/TT-BTM issued 21 February 2000.
The current list for equipment needing to be registered and approved is detailed below:

CT Scanner and gamma scanner;
Cobalt and accelerator equipment;
Simulator equipment;
Magnetic resonance equipment;
Blood filter/sterilizing equipment;
Ultra-sound color Doppler equipment;
X-ray equipment;
Emergency/Recovery equipment;
Laboratory equipment;
Specialty equipment, ie obstetrician, pediatric, and optical equipment;
Sterilizing equipment

Based on Decision 2019/1997/QD-BKHCNMT issued 1 December 1997, the Ministry of Science, Technology, and Environment must inspect imported used medical equipment. The Decision stipulates that imported used medical equipment must retain equal to or more than 80 percent of its life expectancy and must not consume more than 10 percent of fuels or electricity than newer versions of the equipment.
Import tax for medical equipment generally ranges from 0 percent to 5 percent, and the equipment is subjected to a value added tax. Effective as of 1 January 1999, a new value added tax was imposed on goods and services consumed in Vietnam. The standard VAT rate for medical equipment is 5 percent and a spare part is 10 percent. Unless otherwise approved by the Ministry of Finance, taxes are based upon the calendar year, regardless of a company's fiscal year. Medical equipment imported from countries that have bilateral trade agreements with Vietnam receive a preferential tax rate. Import taxes imposed on medical equipment are classified in Decision 172/TT-BTC issued on 22 December 1998.
In general, all importation procedures for medical equipment take about two to three weeks and there are no major difficulties during this process.
Labeling Requirement
On August 30 1999, the Prime Minister promulgated Decision No. regarding the regulation for labeling of domestically circulated goods and imported/exported goods. According to this law, label affixation is required for medical equipment. The importer must provide information on the label that mentions the

Name of the equipment;
Name and address of traders responsible for the equipment, ie, the importer in this case;
Instructions on using, operating and preserving the equipment; and
Origin of the equipment.

Used equipment, that has been refurbished, has significant market potential in Vietnam, especially in the private Vietnamese clinic sector.

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