Print version of Varying entries in the ARTG - medical devices and ...
2 5 - UL...implants assessed by a European Notified Body as Class IIb underthe European regulatory...
Transcript of 2 5 - UL...implants assessed by a European Notified Body as Class IIb underthe European regulatory...
Sponsors seeking to reclassify partial
hip, knee and shoulder implants may use
summary technical reports as interim evi-
dence (pending the provision of a Design
Examination Certificate from a European
Notified Body) for inclusion of the device
in the Australian Register of Therapeutic
Goods (ARTG) as a Class III device1. There
are three limitations to this provision:
• itappliestoreclassificationapplicationsreceivedbytheTherapeuticGoodsAdministrationonorbefore30June2014;
• itappliestothereclassificationofpartialhip,kneeandshoulderjointimplantsassessedbyaEuropeanNotifiedBodyasClassIIbundertheEuropeanregulatoryframework;and
ifadecisionismadetoincludethedeviceintheARTG,anadditionalconditionwillbeappliedtotheARTGentryrequiringthesponsortoprovideanappropriateDesignExaminationCertificatewithin12monthsofsubmittingthesummarytechnicalreport.
2 5 Expect 31 new mandatory medical standards from China
Regulatory updates provided in partnership with the Journal of Medical Device Regulation
2014 • Spring Global Regulatory Digest
Technical Reports to be Accepted as Interim Evidence for Joint Reclassifications in Australia
Reference: 1.http://www.tga.gov.au/industry/devices-reforms-summary-technical-reports.htm#.Ut5aYrTLfIU.
Colombia requires Market Authorization for 35 previously exempt devices
[ 2014•Spring]
MANy PREvIoUSLy-ExEMPT DEvICE TyPES wILL REqUIRE MARkET AUThoRISATIoN IN CoLoMbIACompanies have until 11 August 2014 to
fulfil the Colombian market authoriza-
tion requirements for 35 types of medical
devices that are currently exempt from
registration1. Companies that fail to com-
ply with the new rules and are found to
still have unregistered products during an
inspection will face sanctions. Devices that
will need to be registered by 11 August
2014 include the following:
• crutchesandwalkers;
• mechanical,electrical,mechano-electricalandelectronicwheelchairs;
• anti-sorebedmattresses;
• lampsusedinmedicalprocedures;
• mechanicalandelectronicscales;
• hospitalbeds;
• steriledisposablesurgicalclothing;
• oscillatingsawsforplaster;
• diagnosticimagingsystems;
• disinfectingsystemsandsolutions;
• binocularmicroscopes;
• microtomes;
• tissueprocessingequipment;
• bloodcomponentdividingequipment;
• breastmilkextractors;
• staticbicycles,treadmillsandellipticalsteppers;
• surgicaldrapes,disposableornon-disposable;
• electricmassageequipment;
• traysfortheapplicationoffluorideinodontology;
• acetatetraysforteethwhitening;
• salivaejectors;
• pillsfordisinfectionofdentalprosthesesandremovablebraces;
• latexclothingandequipment;
• disposablematrixsystems;
• microbrushes;
• bloodbankcentrifuges;
• tubecentrifugesforlaboratories;
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www.ul.com/medical
• centrifugesforhaematocrit;
• molecularbiologycentrifuges;
• centrifugesforimmunohaematologyinbloodbanks;
• ultracentrifuges;
• microscopeslideprocessorsforfluorescence;
• immunoassayprocessors;
• WesternBlottestprocessors;
• testprocessorsformolecularbiology.
Reference: 1. http://www.invima.gov.co/images/pdf/informate/CIRCULAR%20EXTERNA%20DISPOSITIVOS%20MEDICOS.pdf
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On 20 November 2013, the Japanese gov-
ernment approved a momentous piece
of legislation: the Pharmaceutical Affairs
Law Reform Act or the Pharmaceutical and
Medical Device Law1. This new Law sepa-
rates, for the first time, the regulations
for pharmaceuticals and medical devices,
which are currently regulated in a similar
way under the Pharmaceutical Affairs Law.
The new Law contains a Chapter per-
taining specifically to the regulation of
medical devices, which is completely
independent of the regulatory framework
for pharmaceuticals. Some of the main
revisions include, but are not limited to,
changing from a foreign manufacturer’s
accreditation system to a registration
system, simplified Quality Management
System inspections, specific controls for
standalone software used for diagnostic
purposes, and expansion of the third-party
certification system to reduce the work-
load of the Pharmaceuticals and Medical
Devices Agency.
The Pharmaceutical and Medical Device
Law is expected to come into force later
this year but the exact timing is still
unclear.
Reference
1. http://www.amdd.jp/en/technology/press131128.html.
[ 2014•Spring]
Japan to Regulate Medical Devices Separately Under New Law
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Resources to help understand FDA Combination Product Final RuleIn 2013, the US FDA issued a Final Rule on
cGMP requirements applicable to combina-
tion products. The Final Rule clarified which
cGMP requirements apply for combination
products, while also providing a stream-
lined regulatory framework for firms to use
when demonstrating cGMP compliance for
combination products.
To help your quality and manufactur-
ing teams understand this regulation,
UL EduNeering has developed a new
web-based course, Combination Products
– cGMP Requirements (PHDV93). This
course focuses on the four different types
of combination products as well as the
scope of the new regulation in 21 CFR
Part 4. Learners will also understand how
post-marketing modifications are made,
and how to report post-marketing adverse
events.
This course is now available via the UL
ComplianceWire learning system as well
as UL EduNeering annual GMP library sub-
scribers. This library contains more than 90
courses covering a wide range of GMP and
regulatory topics. To review this course,
contact Pat Thunell at UL at pat.thunell@
ul.com or 609.627.5302.
[ 2014•Spring]
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China Plans to Issue 104 New Medical Device StandardsFrom 1 October 2014, the China Food and Drug Administration plans to start releasing
104 medical device industry standards that it approved in Notice No 361. Of these
standards, 31 are mandatory industry standards and 73 are voluntary industry standards.
Reference: 1. http://www.sfda.gov.cn/WS01/CL0634/93642.html.
Class III UDI Sept. 24, 2014 Implementation Date ApproachingThe Food and Drug Administration
(FDA) has released a final rule
(https://www.federalregister.gov/
articles/2013/09/24/2013-23059/unique-
device-identification-system) requiring
most medical devices distributed in the
United States to carry a unique device
identifier, or UDI. It also applies to certain
combination products that contain devices.
The transition includes a tiered implemen-
tation schedule, starting with the higher
risk devices, which must comply within
one year of the September 24, 2013 publi-
cation date of the final rule. NOTE: There is
a three-year exception for finished devices
that are already labeled and in inventory at
the compliance date.
Companies should become familiar with
the changes to these parts as they imple-
ment a UDI strategy.
Furthermore, as part of the UDI imple-
mentation, FDA will rescind NDC/NHRIC
numbers no later than year 5. However, a
manufacturer may continue to use an FDA
issued NHRIC labeler code if the labeler
submits a request for continued use within
year one, or by Sept. 24, 2014.
UL is actively helping companies demon-
strate compliance to the UDI rule by pro-
viding experienced resources to perform
gap analyses, identify technology path-
ways, prepare project planning documents
and assist in implementing the project
plan. Contact UL at Medical.Inquiry@
ul.com for additional information.
Reference:http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm
www.ul.com/medical
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UL and the UL Logo are trademarks of UL LLC © 2014. BDI 40201
[ 6 ]
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References: 1. Notify US website, 30 October 2013. 2. MFDS Notification No 2013-192, 4 October 2013.
South korea Proposes an Enforcement Rule for its Medical Devices ActAn Enforcement Rule has been drafted1,2
with the aim of increasing the reliabil-
ity of medical devices in South Korea
by verifying their Good Manufacturing
Practice certificate, and by amending
the approval and review processes with
respect to clinical data submission. It
also aims to facilitate a simplified proce-
dure for the modification of an original
business licence by reducing the num-
ber of supporting documents required,
and to improve the current regulations
by abolishing certain qualification
requirements.