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TÜV Rheinland Group China's compliance approval services for
medical devices offer a wide spectrum of options, including performing
safety testing and performance testing, conducting EMC testing,
evaluating software, performing quality assurance management system
audits, and handling CE marking requirements on behalf of the Notified
Body TÜV Rheinland Product Safety GmbH.
Our role can be as basic as explaining the regulatory requirements
and identifying the steps and documentation to meet them; or, we
can help through the entire process, including testing to International,
European and national standards, reporting the results and issuing
compliance certificates and test mark licenses.
With TÜV Rheinland's testing and certifications for Europe,
the United States, Canada and Japan, your products have recognized
and accepted test marks for key markets. As an added benefit, the
same set of tests can be used to prepare a CB Certificate and Test
Report, or to show compliance with essential requirements required
by the European Directives for medical devices.
The major safety standard for electro-medical devices is the IEC
60601 series. Its European equivalent is the EN 60601 series. The
IEC 60601-1 covers all generic requirements including a list of
hazards and their tolerable risk limits.
The IEC 60601-1-X collateral standard series deals with issues such
as electrical medical systems, electromagnetic compatibility, and
X-ray protection. This will be used together with the IEC 60601-1.
The IEC 60601-2-XX series is applicable for specific medical devices
and should be used together with the IEC 60601-1 and applicable
IEC 60601-1-X standards as well.
All testing will be performed either in TÜV Rheinland's own
laboratories, appointed test facilities or witnessed at manufacturer's
premises by our medical device experts.
- GM Mark
- Type Approved Mark
- T Mark
- CB Certicate and Test Report
- cTUVus Mark
- FDA Third Party Review
- "Yakuji" Test Report
- Initial Design Support / Analysis
- International Approvals
- EC Verification
- EC Type Examination
GM Mark and Type Approval Mark
This voluntary test mark gives evidence that the essential safety
requirements of a component to be used in medical devices have been
fulfilled and the production has been inspected by an impartial
organization such as TÜV Rheinland.
The license issued for the Type Approved mark shows both the manufacturer
and the consumer that the component meets the applicable safety
standards.
TUV Rheinland's medical experts can test the following components
according to electro-medical safety standards:
- Power Supply Units
- Transformers
- AC adapter
With the T-mark approval, a medical product can be tested and certified
according to any standard or excerpt of a standard applicable to
that device.
The certificates for this approval are issued under the responsibility
of the subsidiary that carried out the testing and must be signed
therewith by their management. Originally, this approval was initiated
by TÜV Rheinland of North America and later adopted by TÜV
Rheinland subsidiaries throughout Asia.
Currently TÜV Rheinland Group China mainly issues T-mark certificate
for compliance of electro-medical devices with national versions
of the IEC 60601 standard series.
The CB scheme - Testing and certification of electro-medical devices
for the world
The CB scheme is of great assistance to all manufacturers and exporters
who want to market their electro-medical devices in countries participating
in the CB scheme and who therefore need national test marks.
TÜV Rheinland Product Safety GmbH has been integrated in the
CB scheme as a National Certification Body (NCB) for many years.
Our expertise in the field of electro-medical devices made it possible
to be authorized for all IEC60601 standards currently recognized
within the CB scheme. TÜV Rheinland medical experts offer testing
of your devices in our Certification Body Test Laboratories (CBTL)
or even testing based on the TMP or SMT procedures at manufacturer
premises around the world.
Medical approval for the U.S market directly through FDA
The Food and Drug Administration (FDA) is a team of dedicated professionals
working to protect, promote and enhance the health of the American
people. The FDA is responsible for ensuring that:
Food products are safe, wholesome, and sanitary; human and veterinary
drugs, biological products, and medical devices are safe and effective;
cosmetics are safe; and electronics that emit radiation are safe;
regulated products are honestly, accurately and informatively represented;
and, the products are in compliance with the law and FDA regulations.
The FDA identifies and corrects noncompliance and ensures the removal
of any unsafe or unlawful products from the marketplace.
The FDA's Center for Devices and Radiological Health (CDRH) is responsible
for ensuring the safety and effectiveness of medical devices and
eliminating unnecessary human exposure to man-made radiation from
medical, occupational and consumer products.
There are thousands of types of medical devices, from heart pacemakers
to contact lenses. Radiation emitting products regulated by FDA
include microwave ovens, video display terminals, and medical ultrasound
and x-ray machines.
... or through TÜV Rheinland's Third Party Review
TÜV Rheinland of North America is accredited by the FDA as
Third Party Reviewer of 510(k) submissions of certain eligible devices.
The term 510(k) refers to the Federal Food, Drug and Cosmetics Act
section 510(k), otherwise known as "Pre-market Notification."
Information required in a 510(k) submission can be found in the
code of Federal Regulations, Title 21, Part 807, Subpart E. During
the 510(k) review, the submission will be reviewed to determine
if the medical device is substantially equivalent to a device already
legally marketed in the U.S.
The Third Party Review provides an alternative to faster marketing
clearance for the manufacturer. After TÜV Rheinland of North
America completes a review, the submission, including a recommendation,
is sent to the FDA for final review.
Our medical experts in Group China are your direct contact and they
will assist you through the full process of the Third Party Review
in cooperation with our colleagues in America.
Medical device testing for the Japanese market - Third Party Testing
by TÜV Rheinland
TÜV Rheinland Group China's medical experts are proficiently
qualified to evaluate your electro-medical devices according to
the following standards:
- JIS T 0601-1
- JIS T 1001
- JIS T 1002
- JIS T 1005
TÜV Rheinland's medical device assessment already starts during
the design phase
The essential quality aspects and the regulatory requirements, such
as safety, performance, and dependability of a product (whether
hardware, software, services, or processed materials) are established
during the design and development phase. Deficient design can be
a major cause of quality problems.
The nature of product evaluations, design reviews, process validations,
etc, should be proportional to the nature of the risks of the device.
Use of techniques, such as fault tree analysis and failure mode-and-effects
analysis can be helpful in determining the nature of possible design
flaws and the risks that they entail.
TÜV Rheinland's medical device experts can assist you in any
step of the design phase:
- Design and development planning
- Design input
- Design output
- Design review
- Design verification
- Design validation
- Design changes
The EC verification conformity assessment route requires the manufacturer
of the medical device (or its authorized agent) to declare that
the product complies with all appropriate AIMD, MDD or IVDD requirements
and applicable technical specifications. Compliance is based on
examinations and tests performed by the notified body, TÜV
Rheinland Product Safety GmbH. The notified body may, at its discretion,
evaluate 100 percent of the devices or use rational statistical
sampling methods. If it chooses to use statistical (batch) sampling,
random samples must be taken from each batch or lot manufactured.
If the batch were accepted, all products in the batch may be placed
on the market (except those in the sample that failed).If the batch
were rejected, the notified body must take appropriate measures
to prevent the batch from being placed on the market. If there would
be a trend of frequent batch rejection, the notified body may ultimately
suspend the statistical verification process and revert to 100 percent
examination and testing.
Sampling and statistical control of products is based on attribute
testing, requiring a sampling system that ensures a limited quality
corresponding to a probability of acceptance of five percent, with
a nonconformity percentage of between three percent and seven percent.
This conformity assessment route requires the notified body to test
and evaluate a representative sample of the device to ensure that
it fully complies with the applicable requirements of the AIMD,
MDD or the IVDD and the appropriate technical standards. The EC
Type Examination (e.g. MDD Annex III) route is used with the procedures
defined as EC Verification (e.g. MDD Annex IV) or EC Declaration
of Conformity - Production Quality Assurance (e.g. MDD Annex V).
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