| Medical
and Laboratory Devices
As
a medical products manufacturer, your
business success depends on making
products that operate safely and effectively.
UL
can help your company design and produce
quality medical devices essential
to earning worldwide market acceptance.
The continuing
globalization of commerce is bringing
change -- the movement toward harmonization
of standards. Harmonization can expedite
the certification process for those
who want to sell in various countries.
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| For example, by meeting
EMC requirements for Europe, you also
meet EMC requirements for the United
States and Japan. And many of the efficacy
and quality control requirements of
the U.S. Food and Drug Administration
(FDA) are consistent with those of Europe.
We
can assist you with all international
compliance issues. As your single
source of global compliance support,
UL can recommend and implement a service
package that takes advantage of the
opportunities offered by international
harmonization that best meets your
conformity assessment needs.
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What
Can UL Do For You?
We
can evaluate…
- Medical devices
- In Vitro Diagnostic Directive (IVDD)
- Laboratory equipment and other measurement
devices (general laboratory instrumentation
and devices)
and
provide you with:
Access
to USA:
- UL Mark
- FDA 510k Pre-market Notification Program
Access
to Canada:
- C-UL Mark
- CMDCAS Registration for Canada
Access
to Europe:
- CE Mark under MDD
- CE Mark under IVDD
Access
to Latin America:
- Argentina - S Mark
- Brazil - INMETRO/UL Mark and Brazilian
Health Ministry Registration
- Mexico - NOM Mark
Access
to Asia:
- Special testing to comply with Japanese
requirements
Access
to the rest of the world:
For
additional information about certification
of medical equipment, please, follow this
link.
For
more details about the requirements and
procedures to certify:
Medical
Equipment - click
here.
Professional
Medical Equipment - click
here.
UL
Affiliates can assist you to get the necessary
certification for this product category.
| Certification
in Latin America |
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