Cablegate: Import Regulations for Used Medical Equipment
This record is a partial extract of the original cable. The full text of the original cable is not available.
UNCLAS CARACAS 001332
USDOC FOR 6132/MAS/MFG/OHCG/SFRANCIS
USDOC FOR 3134/OIO/WH/DDEVITO
E.O. 12958: N/A
TAGS: BEXP ETRD VE
SUBJECT: IMPORT REGULATIONS FOR USED MEDICAL EQUIPMENT
REF: USDOC 00292
1. The questions asked in reftel will be answered in the same
A.There are no special regulations or customs tariffs that
apply to used or refurbished medical equipment, which do not
apply to new products. No customs duties discounts are granted
for the import of used equipment. However, internal
regulations within the government prohibit all government
entities or operations from importing or using used equipment.
While not subject to laws or regulations, private banks upon
financing the acquisition of medical equipment as a rule will
not grant financing to imports of used or refurbished
equipment. We have heard of some isolated cases, where a bank
will entertain a request for financing if the refurbished
equipment is covered by warranties.
B.If a medical device has been registered and authorized
for sale by the Ministry of Health and has been given its
registration number, refurbished equipment of the same type
can be legally imported by another company. However, if the
refurbishment included improvements or changes affecting key
components or if the application of the equipment is different
from the originally registered one, the importer should
request a reading from the Ministry to determine whether a new
application for registration would be required.
C.Public health institutions owned by a government agency
including military are not allowed to buy and use refurbished
or used medical devices.
D.There is a somewhat limited market for used or
refurbished medical equipment among the smaller private
hospitals and clinics or among individual physicians. Most of
these potential buyers, however, will require the availability
in the country of spare parts, service and in some cases a
limited warranty. The used equipment market is driven mainly
by the cost difference between used and new equipment.
E.The potential market for used medical equipment consists
mainly of electro-medical or other more expensive pieces of
equipment, such as x-ray machines including dental units,
electrocardiographs, ultrasound equipment, sterilizers,
laparoscopy and colon or stomach viewers but normally does not
include medical/surgical instruments.
F.There appears to be no reprocessing on an industrial
scope of single-use devices nor does there appear to be a
commercial scale of sales of such reprocessed single use
devices. Individual doctors and some of the very small clinics
might at times wash and re-sterilize such devices if they are
considered to be in good enough condition.
2005CARACA01332 - UNCLASSIFIED