About
the Medical Device Regulatory
Profiles for Select Foreign Markets
In most countries, including the U.S., the sale and use of
medical devices is regulated by the central government to safeguard the
public health and welfare. Methods and means of regulation vary widely, but
it is necessary for U.S. exporters of medical devices to comply with the
regulations of each country where it intends to market. Given that all countries
would like to improve healthcare delivery and the need for high quality
medical devices is great, it is often a market's regulations that determine
where exports are possible.
Please look at our Medical Device Regulatory Profiles
for Select Foreign Markets. These Profiles may help determine which
market is best for your company, or clarify the regulatory environment for
markets in which your company is already active.
Disclaimer: The information contained in these profiles is derived
from public sources and is current to the best of our knowledge. For detailed
and definitive information about a country's laws and policies, the
government of the country concerned should be consulted.
Laws and policies change frequently. If your experience has been contrary
to the processes described in any of the Profiles below, please let
us know, so that we may provide more accurate information. No company
or individual would ever be mentioned by name. Please email your input
to Richard.Paddock@mail.doc.gov.
For information about the medical device markets and reimbursement
practices in the profiled markets, please look at the Industry Sector
Analysis reports at http://www.stat-usa.gov.
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