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;

[ 2 ]

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

[ 3 ]

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

[ 4 ]

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]

[ 5 ]

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

Published by UL LLC — Health Sciences Industry The world leader for innovative, customer-focused, market access solutions delivered locally W: ul.com/medical E: Medical.Inquiry@ul.com

THIS DOCUMENT IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

UL and the UL Logo are trademarks of UL LLC © 2014. BDI 40201

[ 6 ]

Providing Essential Information for Regulatory Affairs Specialistssince 2004

Take a look by downloading a free sample from www.globalregulatorypress.comSubscribe now using code JM12DR and receive 6 issues for the price of 4.

for Medical Device Regulatory Information

THE RESEARCHER: Investigating key issues, and providing detailed and in-depth regulatory analyses by renowned global RA, industry and government professionals

THE QUALITY SPECIALIST: Timely, important and sometimes controversial articles on issues relevant to the medical device industry

THE MARKETEER: Global coverage in the focus articles and news updates, not just coverage of the European and US markets

THE REGULATOR: Supported by an Editorial Advisory Board of international experts from industry and government

THE EXECUTIVE: Today’s important issues in an easy-to-use, comprehensible format Journal of Medical Device RegulationTel: +44 (0)1305 770836 Email: sales@globalregulatorypress.com

SOMETHING FOR EVERY PROFESSIONAL:Visit our Bookstore: An extensive library offering guidance documents, white papers and essential articles on regulatory issues.

The Choice for Medical Device Professionals

Settin

g a

Gol

d Standard

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.