NewsTrends
Notified Body Speeds Up CE
Mark Reviews
Chinese Import
Requirements Reduce
Redundancy
Some Class III devices can now have
their European CE mark reviews
completed in 45 working days or less,
thanks to a new program launched
this fall by a notified body.
In the United States, such speed is
unheard of. FDA reviews Class III
devices via the premarket approval
(PMA) process, which in fiscal year
2006 took, on average, 283 days. But
to get on the market in Europe, device
not guarantee a CE mark. Products
that require consultation from other
agencies, such as drug-device combination products or animal-tissue
products, may not be eligible for the
program. Products that are “totally
novel” are not eligible because they
have too much clinical data that need
to be reviewed says Paul Brooks, vice
president and country manager for BSI
Product Services Healthcare.
400
350
Days in Review
300
250
200
150
100
50
0
366
326
283
292
283
229
F Y 01
F Y 02
F Y 03 F Y 04
Fiscal Year
FY 05
FY 06
Average total FDA review days from filing to approval for original PMAs and panel
track PMA supplements. Some of these products can now be reviewed for marketing
in Europe within 45 days.
companies make submissions to notified bodies, which are private entities
that charge a fee.
So, in response to customer demand,
notified body BSI Inc. (Reston, VA)
introduced a program called CE- 45, in
which it will complete the review process in 45 days with either a positive
or negative recommendation. It does
Brooks says that the firm began a
90-day program last year, and although
it was received very well, some clients
wanted a process that was even faster.
“A lot rides on getting a predictable,
understandable CE marking process,”
says Brooks. “CE- 90 is very good in
See Notified Body, page 22
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Agovernment forum held between
the United States and China is
easing the regulatory burden for U.S.
companies that want to import devices
into China. The actions announced
during the meeting could cut device
approval time in half and provide
manufacturers with more access to
the Chinese market.
This fall, the U.S.-China Joint Commission on Commerce and Trade
(JCCT) met to discuss intellectual
property, healthcare, agriculture, procurement, and other trade issues. During the session, China’s Agency for
Quality Supervision, Inspection, and
Quarantine and the State Food and
Drug Administration announced that
they will require only one test, report,
fee, and facility inspection for medical
devices exported to the country.
“We applaud the Chinese government for taking this important step to
reduce redundant regulatory requirements that do nothing to promote the
public health of the Chinese people
and only serve to delay availability of
innovative new products,” says Ralph
Ives, AdvaMed’s executive vice president of global strategy and analysis.
According to the JCCT, the value of
device exports to China was about
$859 million last year.
China’s National Development
Reform Commission also said it
will listen to feedback from the U.S.
government and stakeholders on its
revised draft medical device pricing plan and its device procurement
policies. Under the proposed pricing policy, the Chinese people have
limited access to advanced imported
medical devices, according to the
JCCT. AdvaMed hopes that a dialogue between the U.S. government
and China regarding procurement
will enable fairness and transparency
on tendering process issues.
—Maria Fontanazza
