market access market access JULY/08/AUG

market access
Cover Story
International Approvals
Global Market Compliance (continued)
In some countries, the product’s associated
documents must be written in the local language.
For example, Taiwan requires Simple Chinese as
opposed to Mandarin Chinese. In some cases, a local
compliance agency can assist with translation or will
accept an English manual for testing and certification
purposes with the guarantee that a local language
manual will be provided with the imported product.
A local compliance agency can translate these
documents for the manufacturer – another benefit of
having a local office.
Additionally, all documents must display the product’s
appropriate warnings and ratings. Rating labels
are reviewed especially closely to ensure it has
the correct ratings, safety warning and certificate
numbers to pass through customs.
budgeting time for the certification process
When launching a product globally, manufacturers must
prepare to work with either the country’s government or
a local regulatory agency. A country can require multiple
preliminary steps for certification, which can extend the
certification process altogether.
ConTInUeD on pAge 5
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The lead time for certifying a product varies
depending on the product, country and whether
certification is through a government authority or
through a national Certification Body with a local
office. Certifying your product can take anywhere
from 1 week to 3 months, sometimes longer if it’s
through a government authority or there are issues
with the product passing.
In China, for example, the manufacturer must
have its product tested for EMC by a government
lab. The manufacturer can submit a safety report
and certificate (CB scheme) to the government’s
regulatory agency. However, the government must
test product samples in its own test laboratories for
the product to receive the China CCC certification
mark. The timeframe for this entire process depends
on the length of the testing cycle and the product’s
ability to pass government testing without issues.
Furthermore, all telecommunications products must
be tested in-country in China for telecom approval.
local expertise
It is a very daunting task to meet compliance in
the global market. Even if you have the technical
understanding of the process, certifying a
product worldwide requires familiarity with the
local country’s regulations, processes and even
government contacts. Therefore, in-country
personnel will bring an insider’s approach, helping
smooth the path toward global compliance.
Moreover, in many cases local representation is
required by law to obtain an approval certificate
for a product. Until the day when global compliance
becomes harmonized, taking the local route – one
day and one country at a time – yields the most
success.