the sted............... © locus consulting michael flood be fieaust cpeng (biomedical) locus...

The STED ...............The STED ...............

© Locus Consulting

Michael Flood Michael Flood BE FIEAust CPEng (Biomedical)BE FIEAust CPEng (Biomedical)

Locus Consulting Pty LtdLocus Consulting Pty Ltd

AUSTRALIAAUSTRALIA

June 2011June 2011

Has it been a success ???Has it been a success ???

In the beginning ..........In the beginning ..........

RecordsRecords• DesignDesign• ValidationValidation• VerificationVerification• Master fileMaster file

Quality management systemsQuality management systems

Manufacturing recordsManufacturing records• Incoming raw materialsIncoming raw materials• Manufacturing SOPS’sManufacturing SOPS’s• Inspection and testInspection and test• DistributionDistribution

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Master file Master file Technical file Technical file Design dossierDesign dossier

....................................... ??....................................... ??

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In the beginning ..........In the beginning ..........

The MDD .......... Annex II.4The MDD .......... Annex II.4

4. Examination of the design of the product4. Examination of the design of the product

4.14.1. In addition to the obligations imposed by Section 3, the . In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an manufacturer must lodge with the notified body an application for examination of the application for examination of the design dossier design dossier relating relating to the product which he plans to manufacture and which to the product which he plans to manufacture and which falls into the category referred to in Section 3.1falls into the category referred to in Section 3.1..

4.24.2. The . The application must describe the design, application must describe the design, manufacture and performances of the product manufacture and performances of the product in in question. question. It must include the documents needed to assess It must include the documents needed to assess whether the product conforms to the requirements of this whether the product conforms to the requirements of this Directive, as referred to in Directive, as referred to in Section 3.2 (c).Section 3.2 (c).

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3.23.2. Application of the quality system must ensure that the . Application of the quality system must ensure that the products conform to the provisions of this Directive products conform to the provisions of this Directive which apply to them at every stagewhich apply to them at every stage, from design to , from design to final inspectionfinal inspection. . All the elements, requirements and All the elements, requirements and provisions adopted by the manufacturer for his quality provisions adopted by the manufacturer for his quality systemsystem must be documented in a systematic and must be documented in a systematic and orderly manner in the form of written policies orderly manner in the form of written policies and procedures such as quality programmes, and procedures such as quality programmes, quality plans, quality manuals and quality quality plans, quality manuals and quality recordsrecords..

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The MDD .......... Annex II.3The MDD .......... Annex II.3

It shall include in particular an adequate description It shall include in particular an adequate description of:of:

(a) the manufacturer's quality objectives;(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:(b) the organization of the business and in particular:

• the organizational structures, the responsibilities the organizational structures, the responsibilities of the of the

managerial staff and their organizational authority where quality of managerial staff and their organizational authority where quality of design and manufacture of the products is concerned, design and manufacture of the products is concerned,

• the methods of monitoring the efficient operation of the the methods of monitoring the efficient operation of the quality system quality system and in particular its ability to achieve the desired and in particular its ability to achieve the desired quality of design and of product, including control of products which fail quality of design and of product, including control of products which fail to conformto conform; ;

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The MDD .......... Annex II.3 The MDD .......... Annex II.3 ..... Cont’d..... Cont’d

(c) the procedures for monitoring and verifying the (c) the procedures for monitoring and verifying the design of the products and in particular: design of the products and in particular:

• a general description of the producta general description of the product, , including any including any variants planned, variants planned,

• the design specifications, including the standards which the design specifications, including the standards which will be appliedwill be applied andand the results of the risk analysisthe results of the risk analysis, and , and alsoalso a description of the solutions adopted to fulfil the a description of the solutions adopted to fulfil the essential requirements essential requirements which apply to the products if the which apply to the products if the standards referred to in Article 5 are not applied in full, standards referred to in Article 5 are not applied in full,

• the techniques used to control and verify the design the techniques used to control and verify the design and and thethe processes and systematic measures processes and systematic measures which will be used which will be used when the products are being designed, when the products are being designed,

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• if the device is to be connected to other device(s) if the device is to be connected to other device(s) in in order to operate as intended, order to operate as intended, proof must be provided that proof must be provided that it conforms to the essential requirements when it conforms to the essential requirements when connected to any such device(s)connected to any such device(s) having the characteristics having the characteristics specified by the manufacturer, specified by the manufacturer,

• a statement indicating whether or not the device a statement indicating whether or not the device incorporates, as an integral part, a substance incorporates, as an integral part, a substance as referred as referred to in Section 7.4 of Annex Ito in Section 7.4 of Annex I and and data on the tests data on the tests conducted in this connection, conducted in this connection,

• thethe clinical data clinical data referred to in Annex X,referred to in Annex X, • the the draft draft labelabel and, where appropriate,l and, where appropriate, instructions for useinstructions for use; ;

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(d) (d) the inspection and quality assurance techniques the inspection and quality assurance techniques at the manufacturing stage and in particularat the manufacturing stage and in particular: :

• thethe processes and procedures processes and procedures which will be used, which will be used, particularly as regardsparticularly as regards sterilization, purchasing sterilization, purchasing and the and the relevant documents, relevant documents,

• the the product identification procedures product identification procedures drawn up and kept drawn up and kept up to date from drawings, specifications up to date from drawings, specifications or other relevant or other relevant documents at every stage of manufacturedocuments at every stage of manufacture; ;

(e) (e) the the appropriate tests and trials which will be appropriate tests and trials which will be carried out before, during and after manufacturecarried out before, during and after manufacture, the , the frequency with which they will take place, and the test frequency with which they will take place, and the test equipment used; it equipment used; it must be possible to trace back the must be possible to trace back the calibration of the test equipmentcalibration of the test equipment

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And in Canada ..........And in Canada ..........

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Regulation 32 (1) – An application for a medical device shall Regulation 32 (1) – An application for a medical device shall contain contain • Name of device;Name of device;• Class of deviceClass of device• Device identifier ...... Model number, family name, etcDevice identifier ...... Model number, family name, etc• Name and address of ‘physical’ manufacturerName and address of ‘physical’ manufacturer• Name and address of legal manufacturerName and address of legal manufacturer

• ......................................................................

Regulation 34 (4) An application for a class IV device shall Regulation 34 (4) An application for a class IV device shall contain contain

• Description of the device and materials used in manufacture;Description of the device and materials used in manufacture;• Features of the device that allow it to be used for its intended Features of the device that allow it to be used for its intended

purpose;purpose;• List of countries where sold and any identified postmarket issues;List of countries where sold and any identified postmarket issues;• Risk assessment .... Analysis, evaluation, reduction methods;Risk assessment .... Analysis, evaluation, reduction methods;• Quality plan ..... Practices, resources and activities;Quality plan ..... Practices, resources and activities;• Specification of materials used in manufacturing and packaging;Specification of materials used in manufacturing and packaging;• Description of manufacturing processes for the device(s);Description of manufacturing processes for the device(s);

....................................................................

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Regulation 32 (4) ......... Cont’dRegulation 32 (4) ......... Cont’d

• List of standards complied with in design and manufacture;List of standards complied with in design and manufacture;• Description of the sterilisation method used;Description of the sterilisation method used;• Summary of supporting clinical evidence supporting the Summary of supporting clinical evidence supporting the

intended use;intended use; For devices of human or animal origin, objective evidence of For devices of human or animal origin, objective evidence of

biological safety of the materials used;biological safety of the materials used; For IVD’s – evidence of representative clinical testing;For IVD’s – evidence of representative clinical testing;

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Regulation 32 (4) ......... Cont’dRegulation 32 (4) ......... Cont’d

• Attestation that the QMS conforms, with and has been Attestation that the QMS conforms, with and has been assessed by a CAMDCAS Registrar, to be in comppliance with assessed by a CAMDCAS Registrar, to be in comppliance with ISO 13485ISO 13485

• Device labellingDevice labelling• Summary of investigational (laboratory) testing for IVD’sSummary of investigational (laboratory) testing for IVD’s• Bibliography of all published reports dealing with the use, Bibliography of all published reports dealing with the use,

safety and effectiveness of the device(s)safety and effectiveness of the device(s) Pre-clinical and clinical,Pre-clinical and clinical, Process validationProcess validation Software validationSoftware validation Literature studiesLiterature studies

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While in Australia ........While in Australia ........

Schedule 3 part 1.3 (2)Schedule 3 part 1.3 (2) For the purpose of enabling the assessment to be carried For the purpose of enabling the assessment to be carried

out, the manufacturer must have available, in writing, the out, the manufacturer must have available, in writing, the following information and undertakings:following information and undertakings:

• name and business address name and business address of the manufacturer;of the manufacturer;• details of each manufacturing site details of each manufacturing site where the where the

system is to be applied;system is to be applied;• relevant information about the kind of medical relevant information about the kind of medical

devices devices to which the system is to be applied;to which the system is to be applied;• documentation documentation in relation to the system;in relation to the system;• undertaking by the manufacturer undertaking by the manufacturer to continue to to continue to

comply with the requirements of the system after comply with the requirements of the system after assessment;assessment;

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Australia .......... Australia .......... Cont’dCont’d

Schedule 3 part 1.3 (2) Schedule 3 part 1.3 (2) ..... Cont’d..... Cont’d

• undertaking by the manufacturer undertaking by the manufacturer to ensure that the to ensure that the system is at all times adequate and efficacious;system is at all times adequate and efficacious;

• undertaking by the manufacturer to notify the undertaking by the manufacturer to notify the SecretarySecretary, , or the person in relation to whom the kind of or the person in relation to whom the kind of device is included in the Register, of any information of the device is included in the Register, of any information of the kind mentioned in subparagraph 1.4 (3) (c) (i) or (ii) that the kind mentioned in subparagraph 1.4 (3) (c) (i) or (ii) that the manufacturer becomes aware of in relation to the kind of manufacturer becomes aware of in relation to the kind of medical device.medical device.

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Schedule 3 part 1.3 (5) Schedule 3 part 1.3 (5)

(5)(5) The The documentationdocumentation of the system of the system must include must include adequate information in relation to the following matters:adequate information in relation to the following matters:• the manufacturer’s quality objectives;the manufacturer’s quality objectives;• the organisation of the manufacturer’s business, the organisation of the manufacturer’s business,

including, in particular, a description of the following:including, in particular, a description of the following: the organisational structure of the business;the organisational structure of the business; the responsibilities of managerial staff and their authoritythe responsibilities of managerial staff and their authority the methods of monitoring whether the system is operating the methods of monitoring whether the system is operating

effectivelyeffectively

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the design of the kind of medical device to which the the design of the kind of medical device to which the system is to be applied, including, in particular, the system is to be applied, including, in particular, the following:following:

• details of the processes, systems and measures used for details of the processes, systems and measures used for controlling, monitoring and verifying that at each stage of the controlling, monitoring and verifying that at each stage of the design process, the device complies with the applicable design process, the device complies with the applicable provisions of the essential principles;provisions of the essential principles;

• a general description of the kind of device, and of any variants a general description of the kind of device, and of any variants of the kind of device, that the manufacturer plans to of the kind of device, that the manufacturer plans to manufacture;manufacture;

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details of the design specifications for the kind of device, details of the design specifications for the kind of device, including:including:

• any medical device standard or conformity assessment standard any medical device standard or conformity assessment standard that has been applied to the device; andthat has been applied to the device; and

the results of the risk analysis carried out; andthe results of the risk analysis carried out; and• if no medical device standard or conformity assessment if no medical device standard or conformity assessment

standard, or part only of such a standard, has been applied to the standard, or part only of such a standard, has been applied to the device — the solutions adopted to ensure that each device device — the solutions adopted to ensure that each device complies with the applicable provisions of the essential complies with the applicable provisions of the essential principles;principles;

• for a kind of device that is intended by the manufacturer to be for a kind of device that is intended by the manufacturer to be connected to another device — evidence demonstrating that the connected to another device — evidence demonstrating that the device will comply with the applicable provisions of the essential device will comply with the applicable provisions of the essential principles when it is connected to the other device and both principles when it is connected to the other device and both devices are being used for their intended purposes;devices are being used for their intended purposes;

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• a statement indicating whether or not the kind of device a statement indicating whether or not the kind of device incorporates, or is intended to incorporate, as an integral part, incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, a substance mentioned in clause 7.4 of the essential principles, and, for a device that will do so, data derived from tests and, for a device that will do so, data derived from tests conducted in relation to the device and the substance, and conducted in relation to the device and the substance, and their interaction;their interaction;

• a statement indicating whether or not the device contains a statement indicating whether or not the device contains tissues, cells or substances of animal origin that have been tissues, cells or substances of animal origin that have been rendered non-viable, or tissues, cells or substances of microbial rendered non-viable, or tissues, cells or substances of microbial or recombinant origin;or recombinant origin;

• a copy of the clinical evidence, in relation to the kind of device, a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;required by the clinical evaluation procedures;

• a copy of the information to be provided with the kind of a copy of the information to be provided with the kind of device;device;

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the inspection and quality assurance techniques to be the inspection and quality assurance techniques to be applied in the production of the kind of medical device to applied in the production of the kind of medical device to which the system is to be applied, including, in particular, which the system is to be applied, including, in particular, information about the following:information about the following:

• the processes and procedures to be used (particularly in the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those relation to sterilisation) and the documents relating to those processes and procedures;processes and procedures;

• the procedures to be used for purchasing goods or services in the procedures to be used for purchasing goods or services in relation to the production of the kind of device and the relation to the production of the kind of device and the documents relating to those procedures;documents relating to those procedures;

• product identification procedures to be prepared and kept up-product identification procedures to be prepared and kept up-to-date from drawings, specifications or other documents at to-date from drawings, specifications or other documents at each stage of production;each stage of production;

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the tests or trials to be carried out before, during and after the tests or trials to be carried out before, during and after production of the kind of medical device to which the production of the kind of medical device to which the system is to be applied, including, in particular, information system is to be applied, including, in particular, information about:about:• the frequency with which the tests or trials are to be carried the frequency with which the tests or trials are to be carried

out; andout; and• the equipment (including the traceability of the calibration of the equipment (including the traceability of the calibration of

the equipment) used, or to be used, to carry out the tests or the equipment) used, or to be used, to carry out the tests or trials;trials;

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the system for reviewing experience gained in the the system for reviewing experience gained in the post‑production phase in relation to the kind of medical post‑production phase in relation to the kind of medical device to which the quality management system has been device to which the quality management system has been applied, and the means by which any necessary corrective applied, and the means by which any necessary corrective action will be applied in relation to the design or production action will be applied in relation to the design or production of such devices;of such devices;

whether a conformity assessment standard has been whether a conformity assessment standard has been applied to the system and, if no conformity assessment applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, standard, or part only of a conformity assessment standard, has been applied to the system — the solutions adopted to has been applied to the system — the solutions adopted to ensure that the system complies with subclause (2).ensure that the system complies with subclause (2).

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And then along came the STEDAnd then along came the STED

Work stated in 1999Work stated in 1999

2003 - Published as a ‘Proposed Document’ 2003 - Published as a ‘Proposed Document’

...... And then AHWP published the DRAFT CSDT...... And then AHWP published the DRAFT CSDT• The STED, but much improved !!!The STED, but much improved !!!

2006 - SG1 ....... Back to basics, and the Draft CSDT2006 - SG1 ....... Back to basics, and the Draft CSDT

2007 – Published as a [much revised] ‘Proposed Document’2007 – Published as a [much revised] ‘Proposed Document’

2008 – Published as ‘Final Document’2008 – Published as ‘Final Document’

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Has the STED been useful ....??Has the STED been useful ....??

Yes !!!Yes !!!

No surprises from the regulatorNo surprises from the regulator

Clarity and predictability of submission/ Clarity and predictability of submission/ documentation requirements for a documentation requirements for a manufacturermanufacturer

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Possibly too early to tellPossibly too early to tell

But ..................But ..................

..........All indications to date are positive !!!..........All indications to date are positive !!!

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Has the STED been successful ....??Has the STED been successful ....??

Now on to something different .........Now on to something different .........

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Implementation of a GHTF Regulatory Implementation of a GHTF Regulatory Framework........Framework........

............Lessons Learned............Lessons Learned

Regulation in AustraliaRegulation in Australia

1985 - Introduced regulation of 4 categories of1985 - Introduced regulation of 4 categories of high risk devices high risk devices

1991 - Therapeutic Goods Act & Regulations1991 - Therapeutic Goods Act & Regulations• Therapeutic Goods Administration EstablishedTherapeutic Goods Administration Established• Evaluation of ‘high risk’ devices (Registered)Evaluation of ‘high risk’ devices (Registered)• Notification of ‘low risk’ devices (Listed)Notification of ‘low risk’ devices (Listed)• Establishment of Australian Register of Therapeutic Establishment of Australian Register of Therapeutic

Goods (ARTG)Goods (ARTG)• GMP for selected devicesGMP for selected devices

1994 – GHTF Established .............1994 – GHTF Established .............• ‘‘Internationalisation’ of EU MDD and AIMDInternationalisation’ of EU MDD and AIMD

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1995 – Discussion commenced on ‘harmonisation’ with EU1995 – Discussion commenced on ‘harmonisation’ with EU

1997 – First consultation for new regulatory framework1997 – First consultation for new regulatory framework• Harmonised ......... But with GHTFHarmonised ......... But with GHTF• • •

Late 2002 – New regulations commencedLate 2002 – New regulations commenced• 5 year transition period5 year transition period

Late 2007 – New regulations finally in place fully !!Late 2007 – New regulations finally in place fully !!

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Lesson number 1 -Lesson number 1 -

It doesn’t happen overnight !!!It doesn’t happen overnight !!!

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Australia’s Regulatory FrameworkAustralia’s Regulatory Framework

GHTF based –GHTF based –

• 14 Essential Principles (of safety and performance)14 Essential Principles (of safety and performance)

• 22 Rules of Classification22 Rules of Classification

• 6 possible Conformity Assessment Procedures6 possible Conformity Assessment Procedures

• Quality Management Systems based on AS ISO 13485Quality Management Systems based on AS ISO 13485

• Entry on the Australian Register of Therapeutic GoodsEntry on the Australian Register of Therapeutic Goods ManufacturerManufacturer Sponsor (aka importer)Sponsor (aka importer) ““Kind of Medical Device”Kind of Medical Device”

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EU - Conformity Assessment Procedures

Annex IIDeclaration

of Conformity+

Examinationof the

Product Design(Section 4)

Full Quality Assurance

System(Section 3)(ISO 13485)

Evaluation bythe NB

Annex IIDeclaration

of Conformity



Technicaldocument

checked duringaudit

Evaluation bythe NB

Annex VIIDeclaration

of Conformity

Class I* sterileproducts and

measuring devices

Self Certificationwith

Documentation available.

Annex IIIType Examination

Examination by the NB

Annex IV

DeviceVerification

StatisticalVerification

Examination andTesting by

the NB

Annex IVDevice

Verification

100%Verification

Examination andTesting by

the NB

Annex VDevice

Declarationof Conformity

ProductionQuality Assurance

(ISO 13485)

Evaluation bythe NB

Annex VIDevice



(ISO9003)

Evaluation bythe NB

Market Entry

Desig

nP

rod

ucti

on

Active ImplantsIII

IIbIIa

Active ImplantsIIIIIb

I, I*IIa

Active ImplantsIIIIIbIIa

I* (meas)

IIIIIbIIa

I* (meas)

Active Implants

IIIIIbIIa

I* (meas/ster)

IIbIIa

I* (meas)

I* - Sterile - Measuring Function

NB Surveillance NB Surveillance NB Surveillance NB Surveillance RA Surveillance

Australia - Conformity Assessment Procedures

Part 1Declaration

of Conformity+

Examinationof the

Product Design(Section 4)



Evaluation bythe CAB

Part 1Declaration

of Conformity



Technicaldocument

checked duringaudit


Part 6Declaration

of Conformity

Class I* sterileproducts and

measuring devices



Part 2Type Examination

Examination by the NB

Part 3

DeviceVerification

StatisticalVerification

Examination andTesting by the CAB

Part 3Device

Verification

100%Verification

Examination andTesting by the CAB

Part 4Device



(ISO 13485)


Part 5Device



(ISO9003)


Market Entry

Desig

nP

rod

ucti

on

Active ImplantsIII

IIbIIa

Active ImplantsIIIIIb

I, I*IIa

Active ImplantsIIIIIbIIa

I* (meas)

IIIIIbIIa

I* (meas)

Active Implants

IIIIIbIIa

I* (meas/ster)

IIbIIa

I* (meas)

I* - Sterile - Measuring Function

CAB Surveillance CAB Surveillance CAB Surveillance CAB Surveillance TGA Surveillance

GHTF - Conformity Assessment Procedures

Declaration of Conformity

+Comprehensive

Examinationof the STED

includingProduct Design


System

(ISO 13485)



Examination of the STED


System

(ISO 13485)





Type Examination

Examination by the CAB

DeviceDeclaration

of Conformity


(ISO 13485)


Market Entry

Desig

nP

rod

ucti

on

Class D Class CClass B

Class DClass C

Class A*

Class DClass CClass BClass A*

(meas/ster)

CABSurveillance CAB Surveillance CAB Surveillance RA Surveillance

Class B

Class I* sterileproducts and measuring

devices

Implemented October 2002Implemented October 2002

Two transition periodsTwo transition periods

• Two yearsTwo years

All class A medical devices included on the RegisterAll class A medical devices included on the Register Australian manufacturers must implement a QMSAustralian manufacturers must implement a QMS

• Five yearsFive years

All manufacturers must demonstrate compliance of All manufacturers must demonstrate compliance of products with the new regulationsproducts with the new regulations

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The Chosen Path ……….The Chosen Path ……….

65%65% Full QMS Full QMS

0.4%0.4% Type Examination Type Examination

1.0%1.0% Statistical Verification Statistical Verification

30%30% Production QMS Production QMS

1.3%1.3% Product QMS Product QMS

Full QMSProduction QMS

Statistical Verification

Product QMS

Type Examination

The Australian Register of Therapeutic GoodsThe Australian Register of Therapeutic Goods

A Register is an absolute imperative in …..A Register is an absolute imperative in …..

• Understanding what products are in the marketUnderstanding what products are in the market

• Knowing who is responsible for placing those products in the Knowing who is responsible for placing those products in the marketmarket

But, why ………..But, why ………..

• Facilitate Facilitate Field safety corrective actionsField safety corrective actions RecallsRecalls Postmarket StudiesPostmarket Studies

• Public access Public access (where available)(where available)

Users can locate distributor and/or manufacturerUsers can locate distributor and/or manufacturer

Supporting GHTF DocumentsSupporting GHTF Documents

SG 1 – two documents –SG 1 – two documents –

• SG1 N055:2009 - SG1 N055:2009 - Definitions of the term Manufacturer, Definitions of the term Manufacturer, Authorised Representative, Distributor and ImporterAuthorised Representative, Distributor and Importer

- July 2009- July 2009

• SG1 N65:2010 – SG1 N65:2010 – Registration of Manufacturers and Other Registration of Manufacturers and Other parties and Listing of Medical Devices parties and Listing of Medical Devices

– – September 2010September 2010

In establishing a Register .....In establishing a Register .....

Identify parties subject to registrationIdentify parties subject to registration• ManufacturerManufacturer• Authorised representativeAuthorised representative• ImporterImporter• DistributorDistributor

Identify the information requiredIdentify the information required• NameName• Physical AddressPhysical Address• Scope of activitiesScope of activities• Types of devicesTypes of devices

Often the same organisation

But who to include ..........But who to include ..........

Manufacturer Manufacturer

any natural or legal person who designs and/or manufactures a medical any natural or legal person who designs and/or manufactures a medical

device with the intention of making the finished device available for use, device with the intention of making the finished device available for use,

under his name; whether or not such a medical device is designed and/or under his name; whether or not such a medical device is designed and/or

manufactured by that person himself or on his behalf by a third party(ies).manufactured by that person himself or on his behalf by a third party(ies).

Authorised RepresentativeAuthorised Representative

Any natural or legal person established within a country or jurisdiction who Any natural or legal person established within a country or jurisdiction who has received a mandate from the manufacturer to act on his behalf for has received a mandate from the manufacturer to act on his behalf for specific tasks with regards to the latter’s obligations under that country or specific tasks with regards to the latter’s obligations under that country or jurisdiction’s legislation.jurisdiction’s legislation.

These are These are ‘must have’s’‘must have’s’ in a Register in a Register

How about ...........How about ...........

Distributor (s)Distributor (s) Any natural or legal person in the supply chain who, on his own Any natural or legal person in the supply chain who, on his own

behalf, furthers the availability of a medical device to the end userbehalf, furthers the availability of a medical device to the end user

Importer (s)Importer (s) Any natural or legal person in the supply chain who first makes a Any natural or legal person in the supply chain who first makes a

medical device, manufactured in another jurisdiction, available in a medical device, manufactured in another jurisdiction, available in a country where it is to be marketedcountry where it is to be marketed

Subcontractor (s)Subcontractor (s) Raw materials, contract assemblers, sterilisation, etcRaw materials, contract assemblers, sterilisation, etc

These are These are ‘nice to have’s’‘nice to have’s’

Role of the RegistrantRole of the Registrant

Provide the identified information to the RegisterProvide the identified information to the Register

Attest to its accuracyAttest to its accuracy

Ensure information held in the Register is currentEnsure information held in the Register is current

Provide corrections to the Register where there is Provide corrections to the Register where there is

a change to the information held a change to the information held

Device detailsDevice details

Sufficient information to identify the Sufficient information to identify the responsible partiesresponsible parties

• Name and contact details Name and contact details ManufacturerManufacturer Authorised RepresentativeAuthorised Representative/Distributor/Importer/Distributor/Importer

Sufficient information to identify the DeviceSufficient information to identify the Device

Name/model numberName/model number Identification using international coding systemIdentification using international coding system Other relevant informationOther relevant information

• Intended purposeIntended purpose• ClassificationClassification• Sterility statusSterility status

Generally consists of two databasesGenerally consists of two databases

Register ofRegister of• ManufacturerManufacturer• Authorised representativeAuthorised representative• ImporterImporter

distributor(s)distributor(s)

Listing of Listing of • Medical device details – including Medical device details – including

ManufacturerManufacturer

Authorised representativeAuthorised representative

• ImporterImporter

• distributor(s) ………………….. As appropriatedistributor(s) ………………….. As appropriate

Other issues Other issues

Internet basedInternet based

• Data input by Auth Rep, Importer, Distributor, Data input by Auth Rep, Importer, Distributor,

manufacturermanufacturer

• Reviewed by Regulator ……..accepted/rejectedReviewed by Regulator ……..accepted/rejected

• Notification to submitting party of acceptance/rejectionNotification to submitting party of acceptance/rejection

Maintenance by ???????Maintenance by ???????

Public Access to some or all informationPublic Access to some or all information Some data supplied may be considered confidential by Some data supplied may be considered confidential by

manufacturermanufacturer

Lesson number 2 ......Lesson number 2 ......

In determining register contentIn determining register content

• Be practicalBe practical

• Two types of information Two types of information Need to haveNeed to have Nice to haveNice to have

• Do not be too ambitious in this processDo not be too ambitious in this process

• Remember, the greater the detail, the higher the Remember, the greater the detail, the higher the maintenance overhead …… for both the regulator and maintenance overhead …… for both the regulator and information providerinformation provider

The Australian Register of Therapeutic Goods ………The Australian Register of Therapeutic Goods ………

55%55% Class A Class A 3%3% Class A Class A SterileSterile

0.2% Class A 0.2% Class A with measuringwith measuring

functionfunction

22%22% Class B Class B 15%15% Class C Class C 4%4% Class D Class D 1.0% Class D 1.0% Class D (AIMD)(AIMD)

Class AClass C

Class D Class D (AIMD)

Class A (m) Class A (s)

Class B

But in real life, this means .........But in real life, this means .........

ARTGARTG• All classes of device, A through DAll classes of device, A through D• Approx 35,000 entries for a ‘kind of medical device’Approx 35,000 entries for a ‘kind of medical device’• Lower risk class devices (A – C), low level of detailLower risk class devices (A – C), low level of detail• Higher risk class devices (D), high level of detailHigher risk class devices (D), high level of detail

Canadian RegisterCanadian Register• Only Class B and aboveOnly Class B and above• Detail down to catalog numberDetail down to catalog number• Approx 870,000 entries !!Approx 870,000 entries !!

Best guess – worldwide market -Best guess – worldwide market - 2.5 million devices2.5 million devices+/- .5 million +/- .5 million

www.ebs.tga.gov.auwww.ebs.tga.gov.au

Quality Management SystemsQuality Management Systems

Old systemOld system• Only for some, very specific devices, manufacturers required Only for some, very specific devices, manufacturers required

GMP certification by the TGAGMP certification by the TGA

New frameworkNew framework• All manufacturers, except for Class A devices, required QMS All manufacturers, except for Class A devices, required QMS

based on 13485based on 13485

Two year transition period for local manufacturers to ‘get up Two year transition period for local manufacturers to ‘get up to speed’ and implement QMSto speed’ and implement QMS

A QMS is not built and implemented overnightA QMS is not built and implemented overnight

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Quality Management SystemsQuality Management Systems

Overseas manufacturersOverseas manufacturers• No real issues or difficultiesNo real issues or difficulties• Already in US market (QSR’s) and EU market (MDD)Already in US market (QSR’s) and EU market (MDD)• Good level of complianceGood level of compliance

Local manufacturersLocal manufacturers• Only sterile, implantable, and a couple of others previously Only sterile, implantable, and a couple of others previously

required GMPrequired GMP• Low level of understandingLow level of understanding• But why ......... Never needed it before ......But why ......... Never needed it before ......• Low level of complianceLow level of compliance

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Lesson number three .....Lesson number three .....

Local manufacturers will need high Local manufacturers will need high levels of support to ‘get up to levels of support to ‘get up to

speed’speed’

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Timing of introductionTiming of introduction

Two transition periods Two transition periods • 2 years2 years• 5 years5 years

Resource modellingResource modelling• Early take-upEarly take-up• Steady take-upSteady take-up• Late take-upLate take-up

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Lesson number four ........Lesson number four ........

Everybody leaves it ‘til the last Everybody leaves it ‘til the last minute !!!minute !!!

• Even the TGA ......... ‘adjusted’ IT systems !!!Even the TGA ......... ‘adjusted’ IT systems !!!

Incentives to register earlier rather than laterIncentives to register earlier rather than later• Fee discounts, etcFee discounts, etc• Australia & new IVD frameworkAustralia & new IVD framework

No annual fees for 3/4 years of the transition timeNo annual fees for 3/4 years of the transition time

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Conformity AssessmentConformity Assessment

The CABThe CAB

• Third party test and/or certification bodies designated by the Third party test and/or certification bodies designated by the Regulatory Authority to review the application, by a Regulatory Authority to review the application, by a manufacturer, of an appropriate conformity assessment manufacturer, of an appropriate conformity assessment procedure for a specified range, or ranges of productsprocedure for a specified range, or ranges of products


Role of the CABRole of the CAB

• Pre-marketPre-market

Assessment of application of the conformity Assessment Assessment of application of the conformity Assessment ProcedureProcedure

Issue CertificationIssue Certification

• Post marketPost market On-going surveillance auditsOn-going surveillance audits Approve changesApprove changes

• ‘‘Co-regulator’, in conjunction with RACo-regulator’, in conjunction with RA


‘‘Qualifications’ of the CABQualifications’ of the CAB

• Sufficient Resources & CompetenceSufficient Resources & Competence QMS auditorsQMS auditors Device experts (appropriate to designated activities)Device experts (appropriate to designated activities)

• May engage consultantsMay engage consultants

• Documented procedures & supportDocumented procedures & support

• Internal QMS - Internal QMS - ISO/IEC Guide 62:1996 – General ISO/IEC Guide 62:1996 – General requirements for bodies operating assessment and requirements for bodies operating assessment and certification/ registration of quality systemscertification/ registration of quality systems


‘‘Qualifications’ of the CAB …….Qualifications’ of the CAB …….

• IndependenceIndependence cannot provide services of ‘consultant’cannot provide services of ‘consultant’

• ImpartiallityImpartiallity No conflict of interest No conflict of interest

• ConfidentialityConfidentiality No disclosure of information gained during assessment to a No disclosure of information gained during assessment to a

third party, other than the RAthird party, other than the RA

Role of the Regulatory AuthorityRole of the Regulatory Authority

Public health protectionPublic health protection

Political accountabilityPolitical accountability

Efficient use of ResourcesEfficient use of Resources

The big question …….. ????????The big question …….. ????????

• Should the Regulator take on the role of a CAB, Should the Regulator take on the role of a CAB, • or engage the services of a co-regulator to assist in the or engage the services of a co-regulator to assist in the

processprocess• ………… ………… and focus on Registration and Listing activities,and focus on Registration and Listing activities,• ………… ………… and Postmarket monitoring/surveillanceand Postmarket monitoring/surveillance

Responsibilities of the RAResponsibilities of the RA

Publish designation criteriaPublish designation criteria Establish application processEstablish application process Assessment processAssessment process Designation decisionDesignation decision Review of amendments to scope of designationReview of amendments to scope of designation On-going surveillance of CAB activitiesOn-going surveillance of CAB activities

Responsibilities of the RAResponsibilities of the RA

Have skills to assess activities of CABHave skills to assess activities of CAB

Scope of designation Scope of designation • Some, or all, medical devicesSome, or all, medical devices• IVD’sIVD’s• Active ImplantsActive Implants

Levels of Levels of • IndependenceIndependence• ImpartialityImpartiality• IntegrityIntegrity

Regular & structured surveillance of CAB activities Regular & structured surveillance of CAB activities

Ability to act on findings of CABAbility to act on findings of CAB• Postmarket activitiesPostmarket activities

Other GHTF EconomiesOther GHTF Economies

United StatesUnited States

• External Review Body – Accredited Persons ProgramExternal Review Body – Accredited Persons Program Designated by FDADesignated by FDA Currently 11 in number (but only 6 have completed FDA training)Currently 11 in number (but only 6 have completed FDA training) Assesses QMS of manufacturerAssesses QMS of manufacturer Assesses designated range of Class I and II devicesAssesses designated range of Class I and II devices

• FDAFDA Designates Approved Persons (organisations)Designates Approved Persons (organisations) On-going monitoring process to maintain confidence in On-going monitoring process to maintain confidence in

Authorised PersonAuthorised Person Reviews device assessment report prepared by Authorised Reviews device assessment report prepared by Authorised

PersonPerson

Responsible for regulatory decisionResponsible for regulatory decision

Other GHTF EconomieOther GHTF Economiess

CanadaCanada

• Conformity Assessment Body – RegistrarConformity Assessment Body – Registrar Designated by SCC acting on behalf of Health CanadaDesignated by SCC acting on behalf of Health Canada Currently 14 in numberCurrently 14 in number Assesses QMS of manufacturer – issues CAMDCAS CertificateAssesses QMS of manufacturer – issues CAMDCAS Certificate

• Health CanadaHealth Canada Establishment Establishment licence for licence for

• Class I device manufacturersClass I device manufacturers• Class II, III and IV importersClass II, III and IV importers

DeviceDevice licence for Class II, III and IV medical devices licence for Class II, III and IV medical devices Technical review of class III and class IV device dossierTechnical review of class III and class IV device dossier


Other GHTF EconomiesOther GHTF Economies JapanJapan

• Conformity Assessment BodyConformity Assessment Body

• Registered Certification Body - designated class II devicesRegistered Certification Body - designated class II devices

PMDA (Government Agency) -all other class II, III and IV PMDA (Government Agency) -all other class II, III and IV

devices devices

• Ministry of Health, Labour & WelfareMinistry of Health, Labour & Welfare

Designates Registered Certification BodiesDesignates Registered Certification Bodies Reviews reports prepared by PMDA or RCBReviews reports prepared by PMDA or RCB


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Other GHTF EconomiesOther GHTF Economies AustraliaAustralia

Conformity Assessment Body – TGAConformity Assessment Body – TGA• Animal, microbial or recombinant origin materialsAnimal, microbial or recombinant origin materials• Devices containing medicinesDevices containing medicines• Australian ManufacturersAustralian Manufacturers

Regulatory Authority – TGARegulatory Authority – TGA

• Accepts EC certification for lower risk devicesAccepts EC certification for lower risk devices

• Reviews EC certification decision documentation for Reviews EC certification decision documentation for

higher risk deviceshigher risk devices

• Responsible for regulatory decisionResponsible for regulatory decision

Other GHTF EconomiesOther GHTF Economies

EuropeEurope

• Conformity Assessment Body – Notified BodyConformity Assessment Body – Notified Body

Designated by Competent Authority in each member StateDesignated by Competent Authority in each member State Currently ~75 in numberCurrently ~75 in number


• Competent AuthorityCompetent Authority

Responsible for Responsible for • designation of Notified Bodiesdesignation of Notified Bodies• Oversight of ongoing activities of Notified BodiesOversight of ongoing activities of Notified Bodies• Postmarket monitoringPostmarket monitoring

Cautions ………Cautions ………

EU Proposal – recasting of directives EU Proposal – recasting of directives …..released 2008…..released 2008

• More harmonised/centralised process to ensure more More harmonised/centralised process to ensure more uniformity of NB’suniformity of NB’s

???? Central authority???? Central authority Work of Notified Body Operations GroupWork of Notified Body Operations Group

• Strengthening Co-operation between RA’s with regard to Strengthening Co-operation between RA’s with regard to monitoring performance of NB’smonitoring performance of NB’s

• Greater transparency in work and functioning of NB’sGreater transparency in work and functioning of NB’s

Cautions ……… Cautions ……… (cont’d)(cont’d)

Australian Experience to dateAustralian Experience to date

• Variability of Notified Body reviewsVariability of Notified Body reviews

• Examples of Examples of

expertise lacking in many areas, particularly expertise lacking in many areas, particularly • clinical evidence reviewclinical evidence review• Sterilisation procedures and validation reviewSterilisation procedures and validation review

EC certificate by a NB, but no sterilisation validation in placeEC certificate by a NB, but no sterilisation validation in place Inadequate review of manufacturer’s classification rationaleInadequate review of manufacturer’s classification rationale Little, or no, follow-up of audit non-conformities by NBLittle, or no, follow-up of audit non-conformities by NB

• As evidenced by Audit reports supplied by manufacturersAs evidenced by Audit reports supplied by manufacturers Surveillance audits overdueSurveillance audits overdue

• arbitrary extension of EC certificatesarbitrary extension of EC certificates Retrospective review of technical filesRetrospective review of technical files Incorrect/misleading certificatesIncorrect/misleading certificates

• Including out of scope productsIncluding out of scope products NB auditor recommendation to withdraw certification not NB auditor recommendation to withdraw certification not

accepted by the NBaccepted by the NB

• Some of these issues also identified inSome of these issues also identified in

NBOG Annual reportsNBOG Annual reports EU Commission Public Consultation Paper on Recasting of MDDEU Commission Public Consultation Paper on Recasting of MDD

The Question …….The Question …….

How can a CAB maintain competence when …..How can a CAB maintain competence when …..

85%85% of certificates are issued by of certificates are issued by 1515 of the of the 7777 Notified Notified BodiesBodies ….. …..

0

5

10

15

20

25

% C

ertifi

cate

s issu

ed

Notified Bodies ..............

Lesson number 5 Lesson number 5

Does this mean the system is broken Does this mean the system is broken …………

• Absolutely not ….Absolutely not ….

• But it does mean a RA needs to exercise But it does mean a RA needs to exercise judgement in recognising CAB’s to support judgement in recognising CAB’s to support their regulatory framework.their regulatory framework.

‘‘Adjustments’ in AustraliaAdjustments’ in Australia

Reform drivers -Reform drivers -

EU Proposal (including some very frank admissions !) in2008 to re-cast the EU Proposal (including some very frank admissions !) in2008 to re-cast the MDD, AIMDD and IVDDMDD, AIMDD and IVDD

Review of NBOG annual reports details findings (and corrective actions) of Review of NBOG annual reports details findings (and corrective actions) of the operation of some NB’sthe operation of some NB’s

Several years experience with the current framework, including ‘comparing Several years experience with the current framework, including ‘comparing notes’ with fellow regulatorsnotes’ with fellow regulators

EU up-classification of major orthopaedic joints finalised in September 2010EU up-classification of major orthopaedic joints finalised in September 2010

FDA review of 510(k) process and general ‘tightening up’FDA review of 510(k) process and general ‘tightening up’

Revised EU - Australia MRA ............... SoonRevised EU - Australia MRA ............... Soon

Canada – Australia GMP MRA now in placeCanada – Australia GMP MRA now in place

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ReformsReforms

Re-classification of major orthopaedic joints – hips, knees, Re-classification of major orthopaedic joints – hips, knees, shouldersshoulders

Introduction of CAB’s in AustraliaIntroduction of CAB’s in Australia• Lower risk devicesLower risk devices

Strengthening of MRAStrengthening of MRA• Partnering with, and designation of selected Notified BodiesPartnering with, and designation of selected Notified Bodies

Increasing the detail held on the RegisterIncreasing the detail held on the Register

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Lesson number 6Lesson number 6

A GHTF regulatory framework for A GHTF regulatory framework for medical devices is not medical devices is not

‘set and forget’‘set and forget’

It must adjust to the changing environment, both It must adjust to the changing environment, both scientific and politicalscientific and political

It will require maintenance along the way to stay It will require maintenance along the way to stay relevantrelevant

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