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16 ACCSQ MDPWG Workshop Breakout CSDT

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

<br />

ASEAN Common Submission Dossier <br />

<br />

Template (<strong>CSDT</strong>) <br />

<br />

<br />

Scope <br />

<br />

<strong>Breakout</strong> Session <br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<strong>16</strong> th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

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Copyright ©2012 RAPro <br />

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<br />

• <br />

<br />

Tick<br />

<br />

USD <br />

<br />

USD <br />

<br />

USD <br />

• <br />

• • <br />

• <br />

<br />

• Elements of <strong>CSDT</strong> <br />

<br />

3. ExecuIve Summary <br />

<br />

<br />

4.1 Relevant EssenIal Principles and Method Used to Demonstrate Conformity <br />

<br />

<br />

4.2 Device DescripIon <br />

<br />

<br />

4.3 Summary of Design VerificaIon and ValidaIon Documents <br />

4.4 <br />

Device Labelling <br />

<br />

• <br />

<br />

4.5 Risk Analysis <br />

• <br />

<br />

4.6 Manufacturer InformaIon <br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

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<strong>16</strong> th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Quick Review of CDST <br />

<strong>16</strong> th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

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Technical Documenta@on <br />

• The technical documentaIon provides the evidence used in the <br />

conformity assessment process. <br />

• Documented evidence in support of the manufacturer’s a[estaIon <br />

of conformity to the essenIal principles of safety and performance <br />

• The depth and Iming of the review is likely to be influenced by the <br />

risk class of the medical device, its complexity and the extent to <br />

which it incorporates new technology. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Annex 4 <br />

• ASEAN Common Submission Dossier Template (<strong>CSDT</strong>) <br />

– What it is <br />

• Summary of technical informaIon relaIng to the device <br />

• Allows for assessment of safety and performance of medical device <br />

– What it is not <br />

• Not for control of supply chain <br />

• No informaIon on authorised representaIve, importer, distributor <br />

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Annex 4 <br />

• ASEAN Common Submission Dossier Template (<strong>CSDT</strong>) <br />

1. IntroducIon <br />

The Common Submission Dossier Template (<strong>CSDT</strong>) will harmonize the <br />

differences in documentaIon formats that presently exist in different <br />

ASEAN jurisdicIons. The adopIon of this guidance document in ASEAN <br />

will eliminate the preparaIon of mulIple dossiers, arranged in <br />

different formats but with essenIally the same contents, for <br />

regulatory submission to different regulatory authoriIes. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Very Important Note <br />

The examples provided in this workshop are intended solely to <br />

illustrate ways in which data may be presented in a <strong>CSDT</strong> document. <br />

The examples are not intended to be prescripIve. <br />

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Elements of <strong>CSDT</strong> – <br />

Execu@ve Summary <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Execu@ve Summary <br />

An execuIve summary shall be provided with the common submission <br />

dossier template, which shall include the following informaIon: <br />

• an overview, e.g., introductory descripIve informaIon on the <br />

medical device, the intended uses and indicaIons for use of the <br />

medical device, any novel features and a synopsis of the content of <br />

the <strong>CSDT</strong>; <br />

• commercial markeIng history; <br />

• intended uses and indicaIons in labelling; <br />

• list of regulatory approval or markeIng clearance obtained; <br />

• status of any pending request for market clearance; and <br />

• important safety/performance related informaIon. <br />

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Execu@ve Summary <br />

• introductory descripIve informaIon on the medical device <br />

The AAA Gastrostomy Tube is a silicone balloon-­‐type device <br />

designed for administra:on of feeding and/or medica:on <br />

through an established gastrostomy tract. It is supplied sterile. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Execu@ve Summary <br />

• introductory descripIve informaIon on the medical device <br />

The XXX 1-­‐piece lens is an ultraviolet-­‐ light absorbing posterior <br />

chamber intraocular lens (IOL) that compensates for corneal <br />

spherical aberra:ons. It is designed to be posi:oned in the lens <br />

capsule where the lens should replace the op:cal func:on of the <br />

natural crystalline lens. XXX 1-­‐piece IOLs incorporate a biconvex <br />

aspheric design with a squared posterior op:c edge. <br />

XXX 1-­‐piece lenses are indicated for the visual correc:on of <br />

aphakia in adult pa:ents in whom a cataractous lens has been <br />

removed by extracapsular cataract extrac:on. These devices are <br />

intended to be placed in the capsular bag. <br />

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Execu@ve Summary <br />

• introductory descripIve informaIon on the medical device <br />

The YYY CVC is a polyurethane central venous catheter. A <br />

Pressure Injectable CVC may vary from two to four <br />

noncommunica:ng lumens. The catheter has a soM :p that is <br />

more pliable than the catheter body. Lumens are connected to <br />

separate color-­‐ coded extension lines which have hubs on the <br />

end that are standard Luer-­‐Lock. Cen:meter markings <br />

referenced from the :p are placed along length of indwelling <br />

catheter body to facilitate proper posi:oning. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Executive Summary<br />

Commercial marketing history<br />

• date of first introduction and use<br />

• list of countries where it is marketed<br />

Example<br />

Countries where product<br />

is marketed<br />

USA September 2006<br />

Europe September 2006<br />

Singapore February 2007<br />

Date of first introduction on<br />

market<br />

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Executive Summary<br />

Regulatory approval or marketing clearance obtained<br />

• Registration status in major markets<br />

As submitted or<br />

approved by the<br />

reference agency<br />

Indicate whether “approved”, “submitted”, “not submitted”,<br />

“pending approval ”, “rejected” or “withdrawn), type of<br />

approval obtained and status date<br />

Reference<br />

Intended use<br />

Indications of<br />

Registration status and<br />

Reason for withdrawal<br />

agency<br />

use<br />

date<br />

or rejection (if<br />

applicable)<br />

US FDA<br />

EU Notified<br />

Body<br />

Health Canada<br />

Australia TGA<br />

Japan MHLW<br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Execu@ve Summary <br />

• Important safety or performance related informa@on <br />

Summary of adverse events<br />

Description of adverse<br />

event<br />

Bleeding 2.3%<br />

Vascular complications 1.7%<br />

Frequency of occurrence<br />

(number of reports/total units supplied) in the period of dd/<br />

mm/yyyy to dd/mm/yyyy<br />

Total number of devices supplied in UK, USA and Singapore in the period of<br />

12/03/2005 to 12/03/2008 is 4000<br />

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Execu@ve Summary <br />

• Important safety or performance related informa@on <br />

Summary of Field Safety CorrecIve AcIons (FSCA) <br />

Date of FSCA Reason for FSCA Countries where FSCA<br />

was conducted<br />

Jan 2007 Potential loss of package sterility in USA, EU, Singapore<br />

certain lot numbers of model S1000A.<br />

Apr 2010 Label reflect incorrect model number for Singapore<br />

Lot 34532<br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Execu@ve Summary <br />

• Important safety or performance related informa@on <br />

DescripIon of the following (if the medical device contains these items): <br />

– Animal cells, Issues and/or derivaIves thereof, rendered non-­‐viable (e.g. porcine <br />

heart valves, catgut sutures, etc); <br />

– cells, Issues and/or derivaIves of microbial or recombinant origin (e.g. dermal <br />

fillers based on hyaluronic acid derived from bacterial fermentaIon processes); <br />

– irradiaIng components, ionising (e.g. x-­‐ray) or non-­‐ionising (e.g. lasers, ultrasound, <br />

etc). <br />

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Elements of <strong>CSDT</strong> – <br />

Relevant Essen@al Principles and <br />

Method Used to Demonstrate <br />

Conformity <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Relevant Essential Principles and Method Used to<br />

Demonstrate Conformity <br />

• Essential Principles of Safety and Performance comprises of:<br />

– General requirements of safety and performance that apply to ALL<br />

medical devices<br />

– Design and manufacturing requirements of safety and performance,<br />

some of which are relevant to each medical device<br />

• Manufacturer determines the applicable essential principles and<br />

demonstrates conformity to each applicable essential principle<br />

• Conformity to essential principles is documented in a checklist format<br />

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Relevant Essential Principles and Method Used to<br />

Demonstrate Conformity <br />

Essential Principle<br />

Applicable<br />

to the<br />

device?<br />

Method of<br />

Conformity<br />

Identity of Specific<br />

Documents<br />

General Requirements <br />

1. Medical devices should be designed<br />

and manufactured in such a way that,<br />

when used under the conditions and for<br />

the purposes intended and, where<br />

applicable, by virtue of the technical<br />

knowledge, experience, education or<br />

training of intended users, they will not<br />

compromise the clinical condition or the<br />

safety of patients, or the safety and health<br />

of users or, where applicable, other<br />

persons, provided that any risks which<br />

may be associated with their use<br />

constitute acceptable risks when weighed<br />

against the benefits to the patient and are<br />

compatible with a high level of protection<br />

of health and safety. <br />

Yes <br />

Quality System<br />

Standard:<br />

- ISO 13485:2003<br />

Risk Management<br />

Standard:<br />

- ISO 14971:2007<br />

Design Control<br />

Procedures:<br />

- S83782 <br />

§ Corporate Quality<br />

Manual<br />

§ ISO 13485<br />

Certificate No. 12<br />

§ Risk Management<br />

Report<br />

§ System Design<br />

Specifications<br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Elements of <strong>CSDT</strong> – <br />

Device Descrip@on <br />

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Device Descrip@on <br />

1. Device descripIon & features <br />

2. Intended use <br />

3. IndicaIons <br />

4. InstrucIons of use <br />

5. ContraindicaIons <br />

6. Warnings <br />

7. PrecauIons <br />

8. PotenIal adverse effects <br />

9. AlternaIve therapy <br />

10. Materials <br />

11. Other relevant specificaIons <br />

12. Other descripIve informaIon <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Description<br />

1. Device Descrip@on & Features <br />

– Complete descripIon of medical device <br />

– Principles of operaIon <br />

– Risk class and applicable classificaIon rules <br />

– DescripIon of accessories or products which are used in combinaIon <br />

with the device <br />

– List of configuraIons <br />

– DescripIon of key funcIonal elements <br />

– Labelled pictorial representaIon, if appropriate <br />

– ExplanaIon of any novel features <br />

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Device Description<br />

• Descrip@on of accessories or products which are used in <br />

combina@on with the device <br />

Example: <br />

Accessory Iden@fier Descrip@on of Item <br />

AC Adapter H23443 Secondary or replacement universal power supply with 100-­‐240 V~ 50/60 Hz <br />

Docking <br />

StaIon <br />

G11334 <br />

Docking staIon allow two connecIons provided universal power supply with <br />

100-­‐240 V~ 50/60 Hz and global plugs <br />

Ba[ery <br />

Charger C3432 Adapter unit to charge ba[ery taken out from device <br />

…. … …. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Description<br />

• Descrip@on of accessories or products which are used in <br />

combina@on with the device <br />

Example: <br />

Accessory or products used in combinaIon with Peripherally inserted Central Catheter <br />

(PICC) <br />

The MST Accessory Kit provides the necessary components needed to introduce and <br />

exchange the catheter using the modified Seldinger technique. <br />

The accessory kit consist of : <br />

1. IV Catheter <br />

2. Echogenic-­‐Ipped needle <br />

3. Disposable scalpel <br />

4. Marked 50-­‐cm guidewire <br />

5. Tapered-­‐Ti Sheath Dilator <br />

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Device Description<br />

• Risk Classifica@on <br />

Example: <br />

Intraocular lens <br />

Classified as Class C general medical device according to rule 8, Annex 2 of ASEAN Medical <br />

Device DirecIve, where no excepIon rule applies. <br />

Non-­‐medicated saline eye drop <br />

Classified as Class B general medical device according to rule 5, Annex 2 of ASEAN Medical <br />

Device DirecIve, where excepIon rule of sub-­‐rule 1 applies. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Description<br />

• List of configura@ons <br />

Example <br />

Name as per Device Label Identifier Brief Description of Item<br />

Single lumen CVC Kit 11430 14 Ga x 30 cm Polyurethane CVC Kit<br />

Single lumen CVC Kit 11420 14 Ga x 20 cm Polyurethane CVC Kit<br />

Single lumen CVC Kit 114<strong>16</strong> 14 Ga x <strong>16</strong> cm Polyurethane CVC Kit<br />

Single lumen CVC Kit 1<strong>16</strong>30 <strong>16</strong> Ga x 30 cm Polyurethane CVC Kit<br />

Single lumen CVC Kit 1<strong>16</strong>20 <strong>16</strong> Ga x 20 cm Polyurethane CVC Kit<br />

Single lumen CVC Kit 1<strong>16</strong><strong>16</strong> <strong>16</strong> Ga x <strong>16</strong> cm Polyurethane CVC Kit<br />

… … …<br />

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Device Descrip@on <br />

• Labelled pictorial representa@on <br />

Example: <br />

Central Venous Catheter Kit <br />

Guidewire <br />

Scapel <br />

Dilator <br />

Extension <br />

Tubing <br />

Syringe <br />

Clamp <br />

Hub <br />

Catheter <br />

body <br />

Introducer Needle <br />

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Catheter <br />

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Device Description<br />

2. Intended use <br />

3. IndicaIons <br />

4. InstrucIons of use <br />

5. ContraindicaIons <br />

6. Warnings <br />

7. PrecauIons <br />

8. PotenIal adverse <br />

effects <br />

InformaIon typically <br />

found in the <br />

InstrucIons For Use <br />

(IFU) <br />

Provide IFU to meet <br />

requirements of these <br />

secIons <br />

SecIons not found in IFU must be addressed separately in <strong>CSDT</strong> submission <br />

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Device Description<br />

2. Intended Use <br />

• Use for which the medical device is intended, for which it is suited according to <br />

the data supplied by the manufacturer in the instrucIons as well as the <br />

funcIonal capability of the device. <br />

3. Indica@ons <br />

• descripIon of the disease or condiIon that the device will diagnose, treat, <br />

prevent, cure or miIgate and includes a descripIon of the target paIent <br />

populaIon for which the device is intended <br />

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Device Description<br />

2. Intended Use <br />

3. Indica@ons <br />

Example: Intraocular Lens <br />

Intended use: <br />

Intended to be posiIoned in the posterior chamber of the eye, funcIoning as a refracIve <br />

medium to replace the natural crystalline lens in the visual correcIon of aphakia. <br />

Indica@ons: <br />

Designed for implantaIon amer extra-­‐capsular cataract extracIon or phacoemulsificaIon of <br />

cataracts. The lens is intended for placement in the capsular bag <br />

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Device Description<br />

2. Intended Use <br />

3. Indica@ons <br />

Example: Hip Stem <br />

Intended use: <br />

Femoral stem is for total or hemi-­‐hip arthroplasty <br />

Indica@ons: <br />

Indicated for the following condiIons: PaIent condiIons of noninflammatory degeneraIve <br />

joint disease (NIDJD), e.g., avascular necrosis, osteoarthriIs and inflammatory degeneraIve <br />

joint disease (IJD), e.g., rheumatoid arthriIs; those paIents with failed previous surgery <br />

where pain, deformity, or dysfuncIon persists; revision of previously failed hip arthroplasty. <br />

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Device Description<br />

4. Instruc@ons For Use <br />

• InformaIon from the manufacturer on the procedures, methods, frequency, <br />

duraIon, quanIty and preparaIon to be followed for safe use of the medical <br />

device. <br />

• InstrucIons needed to use the device in a safe manner shall, to the extent <br />

possible, be included on the device itself and/or on its packaging by other <br />

formats / forms. <br />

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Device Description<br />

5. Contraindica@ons <br />

• DescripIon of the disease or condiIon and the paIent populaIon for which <br />

the device should not be used for the purpose of diagnosing, treaIng, curing <br />

or miIgaIng. <br />

• ContraindicaIons are condiIons under which the device should not be used <br />

because the risk of use clearly outweighs any possible benefit. <br />

6. Warnings <br />

• Specific hazard alert informaIon that a user needs to know before using the <br />

device. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Description<br />

7. Precau@ons <br />

• Alerts the user to exercise special care necessary for the safe and effecIve use <br />

of the device <br />

• Includes acIons to be taken to avoid effects on paIents/users that may not be <br />

potenIally life-­‐threatening or result in serious injury, but about which the user <br />

should be aware <br />

• PrecauIons may also alert the user to adverse effects on the device of use or <br />

misuse and the care necessary to avoid such effects. <br />

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Device Description<br />

8. Poten@al Adverse Effects <br />

• PotenIal undesirable and serious outcomes (death, injury, or serious adverse <br />

events) to the paIent/user, or side effects from the use of the medical device, <br />

under normal condiIons. <br />

9. Alterna@ve Therapy <br />

• DescripIon of any alternaIve pracIces or procedures for diagnosing, treaIng, <br />

curing or miIgaIng the disease or condiIon for which the device is intended <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Description<br />

10. Materials <br />

• list of materials of the medical device making direct contact (e.g. with the <br />

mucous membrane) or indirect contact (e.g., during extracorporeal circulaIon <br />

of body fluids) with a human body <br />

• complete chemical, biological and physical characterisaIon of the materials of <br />

the medical device making either direct or indirect contact with a human body <br />

• for medical devices intended to emit ionising radiaIon, informaIon on <br />

radiaIon source (e.g. radioisotopes) and the material used for shielding of <br />

unintended, stray or sca[ered radiaIon <br />

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Device Description<br />

11. Other Relevant Specifica@ons <br />

• List of features, dimensions and performance a[ributes of the medical <br />

device, its variants and accessories that would typically appear in the <br />

product specificaIon made available to the end user, e.g. in brochures and <br />

catalogues <br />

12. Other Descrip@ve Informa@on <br />

• DescripIon of any other important characterisIcs of the medical <br />

device that is not addressed in the preceding secIons <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Elements of <strong>CSDT</strong> – <br />

Summary of Design Verifica@on and <br />

Valida@on Documents <br />

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Summary of Design Verification and Validation<br />

Documents <br />

1. SterilisaIon validaIon (for devices supplied sterile) <br />

2. Shelf life data <br />

3. Projected useful life <br />

4. Metrological requirements (for devices with a measuring funcIon) <br />

5. Pre-­‐clinical studies <br />

6. Clinical evidence <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Summary of Design Verification and Validation<br />

Documents <br />

Sterilisa@on valida@on (for devices supplied sterile) <br />

• InformaIon on the sterilisaIon validaIon method used, sterility assurance level <br />

(SAL) a[ained, standards applied, sterilisaIon protocol, summary of validaIon <br />

results <br />

• IniIal sterilisaIon validaIon including bioburden tesIng, pyrogen tesIng, <br />

tesIng for sterilant residues (if applicable) and packaging validaIon. If iniIal <br />

sterilisaIon validaIon is not performed, adequate jusIficaIon must be <br />

provided. <br />

• Evidence of the ongoing revalidaIon of the process (e.g, evidence of <br />

revalidaIon of the packaging and sterilisaIon processes) <br />

• Post-­‐sterilisaIon funcIonal test on the medical device <br />

• If sterilant is toxic or produces toxic residuals, test data and methods that <br />

demonstrate that post-­‐process sterilant and/or residuals are within acceptable <br />

limits <br />

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Summary of Design Verification and Validation<br />

Documents <br />

Stability Studies (for devices with a shelf life) <br />

Data demonstraIng that the relevant performances and characterisIcs of the <br />

medical device are maintained throughout the claimed shelf life which the “expiry“ <br />

date reflects, including: <br />

i. prospecIve studies using accelerated ageing, validated with real Ime <br />

degradaIon correlaIon; or <br />

ii.<br />

iii.<br />

retrospecIve studies using real Ime experience, involving e.g. tesIng <br />

of stored samples, review of the complaints history or published <br />

literature etc.; or <br />

a combinaIon of (i) and (ii). <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Summary of Design Verification and Validation<br />

Documents <br />

Projected Useful Life <br />

For certain devices that do not have expiry dates (e.g. infusion pump, <br />

digital thermometer), the projected useful life of the medical device <br />

must be provided. Manufacturers may refer to ISO/TR 14969 (Medical <br />

devices – Quality management systems – Guidance on the applicaIon <br />

of ISO 13485:2003) for informaIon on how to determine the <br />

projected useful life <br />

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Summary of Design Verification and Validation<br />

Documents <br />

Metrological requirements (for devices with a measuring func@on) <br />

For medical devices with a measuring funcIon where inaccuracy could <br />

have a significant adverse effect on the paIent, studies demonstraIng <br />

conformity with metrological requirements shall be provided. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Summary of Design Verification and Validation<br />

Documents <br />

Pre-­‐clinical studies <br />

All pre-­‐clinical laboratory or animal studies, as appropriate for the medical device, <br />

for e.g: <br />

• BiocompaIbility studies <br />

• Physical test data <br />

• Animal studies that provide evidence of safety and performance of the medical device <br />

• Somware verificaIon and validaIon (for devices incorporaIng somware) <br />

• Biological safety data for devices incorporaIng animal or human cells, Issues or their <br />

derivaIves <br />

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Summary of Design Verification and Validation<br />

Documents <br />

Pre-­‐clinical studies <br />

Biological safety (for devices containing biological material) <br />

– a list of all materials of animal, human, microbial and/or recombinant origin <br />

used in the medical device and in the manufacturing process of the medical <br />

device <br />

• Including cells, Issues, derivaIves <br />

– detailed informaIon concerning the selecIon of sources/donors <br />

– detailed informaIon on the harvesIng, processing, preservaIon, tesIng and <br />

handling of Issues, cells and substances <br />

– process validaIon results for manufacturing procedures in place to minimise <br />

biological risks (e.g. viruses and other transmissible agents) <br />

– full descripIon of the system for record keeping to allow traceability from <br />

sources to the finished medical device. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Summary of Design Verification and Validation<br />

Documents <br />

• Example of summary of studies in tabular format <br />

4.3.1 Biocompa@bility Tes@ng <br />

The tests as recommended in ISO 10993-­‐1 were conducted. All tesIng was conducted on <br />

sterilized finished product. <br />

Summary of biocompaIbility tests conducted are tabulated below: <br />

Test<br />

Method/<br />

Standard<br />

Acceptance criteria<br />

Cytotoxicity ISO 10993-5 No evidence of<br />

significant cell lysis or<br />

toxicity<br />

Results<br />

There was no evidence<br />

of significant cell lysis<br />

or toxicity with<br />

exposure to the test<br />

extract. Meets<br />

requirement of ISO<br />

10993-5<br />

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Summary of Design Verification and Validation<br />

Documents <br />

• Example of summary of studies in narraIve format <br />

4.3.2 Physical Tes@ng <br />

A summary of the physical tesIng conducted is provided. <br />

Stent deployment tes@ng <br />

This test was conducted to determine the stent deployment pressure and the ability of <br />

the balloon catheter to be withdrawn from the stent. Twenty each of the 3 mm and 4 mm <br />

stent systems were tested. …. <br />

…. <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Summary of Design Verification and Validation<br />

Documents <br />

Clinical Evidence <br />

Clinical evaluaIon report for the device <br />

• Report documents the assessment and analysis of clinical data to verify the clinical <br />

safety and performance of the device when used as intended by the manufacturer <br />

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Summary of Design Verification and Validation<br />

Documents <br />

Clinical Evidence <br />

• Process for generaIng clinical data and clinical evaluaIon <br />

Genera@on of clinical data <br />

• Clinical invesIgaIon <br />

• Clinical experience <br />

• Literature search <br />

Clinical data <br />

• Clinical invesIgaIon data <br />

• Clinical experience data <br />

• Literature based data <br />

Inclusion of clinical evidence in <br />

technical documentaIon <br />

Clinical evidence <br />

Clinical evaluaIon report with relevant <br />

clinical data <br />

Clinical evalua@on – assessment and <br />

analysis of clinical data <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Elements of <strong>CSDT</strong> – <br />

Device Labelling <br />

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Device Labelling <br />

• The device labelling refers to any wri[en, printed or graphic <br />

representaIon <br />

– affixed to a medical device or any part of its packaging, or, <br />

– accompanying a medical device, <br />

when the medical device is being supplied <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Device Labelling <br />

• Copies (in original colour) of: <br />

– Labels on the device and its packaging (primary and secondary levels) <br />

• Can be provided in the form of artwork <br />

• Provide for all the components of a medical device system, all members <br />

of a medical device family and all accessories to be registered <br />

• A representaIve label may be submi[ed, provided the variable fields on <br />

the artwork are annotated, and the range of values for the variable fields <br />

are indicated <br />

– InstrucIons for use (including operaIng manual and user manual) <br />

– PaIent informaIon leaflet (where applicable) <br />

• PromoIonal material (including brochures and catalogues) <br />

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Device Labelling <br />

• Example of Product Label <br />

Values of variable field on product label <br />

A:<br />

REF<br />

B:<br />

Stent Diameter<br />

C:<br />

Stent Length<br />

S12346 2.5 mm 8 mm<br />

S12356 2.5 mm 12 mm<br />

S12366 2.5 mm 14 mm<br />

Lot Number is YYYYMMXX. YYYY is year and MM is <br />

month of manufacture. XX is running number for <br />

the month. <br />

Expiry date is YYYY-­‐MM format <br />

B <br />

C <br />

A <br />

Alpha Medical Manufacturing Ltd<br />

Alpha-1 Coronary Stent System<br />

Content:<br />

One Alpha-1 Coronary Stent mounted on CHARGE<br />

Delivery Catheter<br />

Stent Diameter: 2.5 mm<br />

Stent Length: 8 mm<br />

S12346<br />

20110111<br />

2015-01<br />

Alpha Medical Manufacturing Ltd<br />

111 ABC Road<br />

Singapore<br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Elements of <strong>CSDT</strong> – <br />

Risk Analysis <br />

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Risk Management <br />

• Risk management report for the design of the device and its <br />

manufacturing process <br />

• Accompanying documents referenced in the report, including the <br />

risk management plan, results of risk assessment and risk control <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Risk Management <br />

• Recommended: Conduct risk management acIviIes according to ISO 14971 <br />

• ISO 14971 specifies that manufacturer is required to carry out a review of the risk <br />

management process conducted for the device. <br />

• Purpose of review is to ensure that <br />

– the risk management plan has been appropriately implemented <br />

– Overall residual risk is acceptable <br />

– appropriate methods are in place to obtain relevant producIon and post-­producIon<br />

informaIon <br />

• Risk management report records the results of review of the risk management <br />

process conducted for the device <br />

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Elements of <strong>CSDT</strong> – <br />

Manufacturer Informa@on <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Manufacturer Informa@on <br />

• IdenIfy all sites (name and full address) for design and manufacturing acIviIes <br />

(including contract manufacturers and contract sterilizers) <br />

– IdenIfy the acIviIes conducted at different manufacturing sites <br />

– Provide Quality Management System (QMS) cerIficates for all design and <br />

manufacturing sites (including contract manufacturers and contract <br />

sterilizers) <br />

Site Address Activity<br />

XXX Corporate HQ 123, Main Street, Singapore Design<br />

XYZ Manufacturing 67, Down Town, Shenzhen, China Manufacturing<br />

Contract Sterilizer 9, Suburban, Shenzhen, China Sterilization<br />

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Manufacturer Informa@on <br />

• Provide flowchart of main steps in the manufacturing process. <br />

– Flow chart should indicate the following: steps where materials enter the <br />

process, in-­‐process controls, sterilisaIon, packaging, final product controls <br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Manufacturer Informa@on <br />

An example of a flowchart for the manufacturing process of <br />

a stent delivery system <br />

Manufacturing process <br />

flow for sub-­‐assemblies <br />

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Points to note<br />

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<strong>16</strong>th <strong>ACCSQ</strong>-­‐<strong>MDPWG</strong> <strong>Workshop</strong>: 8 to 9 October 2012 <br />

Preparing and Submitting a <strong>CSDT</strong> Dossier <br />

• Prepare the <strong>CSDT</strong> dossier containing informaIon described in all secIons <br />

of the <strong>CSDT</strong> <br />

• Where there are secIons not applicable to the medical device, the reason <br />

for the non-­‐applicability should be provided under the secIon heading <br />

• Copies of labelling, regulatory approval and QMS cerIficates and reports <br />

referenced within <strong>CSDT</strong> dossier may be provided as annexes to the <br />

dossier <br />

• All copies of labelling, cerIficates, reports and other documents <br />

submi[ed must be legible <br />

• All reports submi[ed as part of the <strong>CSDT</strong> should be signed-­‐off and dated <br />

by an authorised person issuing the report <br />

• Where supporIng documents such as reports or cerIficates are provided, <br />

every document must be submi[ed in full, i.e. all the pages of a <br />

document must be submi[ed <br />

• All cerIficates submi[ed must be within its validity period <br />

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End of General Medical Device <br />

<strong>CSDT</strong><br />

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