Global Import Regulations for

Venezuela

General Market Condition: No Restrictions, but Government Agencies do not Buy

Source: Report from CS Post (via E-Mail), 22 May 2001

Are there special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment?

There are no restrictions or special tariffs for used medical equipment. The same import duties apply for new and for used equipment.

Can public health institutions buy used or refurbished medical devices?

There are no prohibitions but as a rule the Venezuelan Government agencies will not buy used or refurbished equipment of any type.

Source: ISA Medical, 1 September 2000

Overall hospitals in Venezuela are not managed efficiently according to industry analysts. Therefore it has been difficult to build up a reserve fund for future technology upgrades and acquisitions. The same doctors work in both the public and the private sectors. However, in the public sector the government does not provide adequate tools and equipment, nor the proper infrastructure. This has been the situation over the past twenty years. In Caracas over the past ten years private hospitals were unable to make direct investments as they were greatly affected by the recession. Nevertheless, they managed to form strategic alliances with the medical distributors, which resulted in many private hospitals having the latest technology. Unfortunately this kind of initiative has not taken place in the rest of Venezuela.

Demand of medical equipment and supplies will be determined mainly by importers’ purchasing power, product price and the rate of growth in the market of used equipment. Local statistics indicate that imports of refurbished equipment have grown approximately 60 percent over the past two years. This is the result of the continuous currency devaluation, the limited access to import new equipment, increased health costs and patient’s diminishing purchasing power. The demand for U.S. refurbished equipment is becoming an alternative source for distributors and end users, as long as technical support and service are available.

There is a need in the public health sector for high technology equipment, such as tomographers, ophthalmologic and optical instruments, cobalt pumps (nuclear medicine), magnetic resonance chambers, X-ray apparatus, laboratory and hematology testing equipment, infusion and transfusion equipment, cancer diagnostic and therapy equipment, hemodialysis equipment, electrocardiographs, electroencephalographs, linear accelerators, equipment for heart disease, apparatus for intensive care units and dental equipment.

Vietnam

General Market Condition: Restricted

Source: Industry Sector Analysis, Medical Diagnostic Equipment, 31 January 2002

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.

Source: ISA Medical, 1 January 2001

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, i.e. 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, i.e., the importer in this case;
  
• 
  Instructions on using, operating and preserving the equipment; and
  
• 
  Origin of the equipment.
  

ISA Medical, 1 May 2000

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