21 May 2013

World Metrology Day Symposium in Peru

Dr. Peter LeeKorean Advisor

METROLOGY CONTROL OF MEDICAL DEVICES

Overview

♦ Medical Device Regulations in Korea

♦ Medical Regulatory Control

♦ Comparison with legal metrology control

♦ Complementary control2

Medical Device Regulations1. Medical Device Act

– To administer medical devices efficiently– To improve the public health

2. Enforcement Ordinance(Decree)– Presidential Decree– Regulate items authorized by the Medical Device

Act and necessary items regarding to the enforcement

– Medical device committee operation, etc.

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Medical Device Regulations

3. Enforcement regulation– Ministerial Decree of the Ministry of Health,

Welfare and Family– Regulate items authorized by the Medical

Device Act and Enforcement Decree, and necessary items regarding to the enforcement

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Medical Device Act Establishment

• Announced in May 29, 2003 as a Law, No. 6909• To be put in force in May 30, 2004• Reasons for enacting Medical Device Act.

– To become independent from the Pharmaceutical Affairs Act that focuses on drugs and quasi-drugs

– To improve the regulatory system rationally and efficiently for medical devices

– To enhance its international harmonization for medical device regulatory system

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Medical Device Act Structure

• 8 chapters, 7 sections, the full text 47 articles, Addendum 6 articles– Chapter 1, General provisions(Purpose, Definition,

Designation and Classification)– Chapter 2, Medical device Committee– Chapter 3, Manufacture of Medical device, etc.

(Manufacturing Business, Importing Business, Repairing Business, selling and Rental Business)

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Medical Device Act Structure– Chapter 4, Management of Medical devices, etc.

(Standards, Labeling and Advertising, Handling)– Chapter 5, Vigilance (Tracking, management of

Adverse events)– Chapter 6, Supervision (Inspection, destroy, order for

cease of use, cancellation of license, etc.)– Chapter 7, Supplementary Provisions (Delegation and

commission of Authorities, Protection of Submitted information, etc.)

– Chapter 8, Penalty (Penalty, Administrative Fine, etc.)

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Each Articles Subjects of Medical Device Act

Article Subject Article Subject Article Subject

1 Purpose 9 Re-evaluation 17 Matters to be Observed by Seller, etc.

2 Definition 10 Authorization of Clinical Trial Plan 18 Standard Specifications

3 Designation and classification 11 Amendment to License, etc. 19 Information to be stated

upon Container, etc.

4 Relationship with other Laws 12 Duties of Manufacturers 20 Information to be stated

upon Outer Package

5 Medical Device Committee 13Notification of Discontinuation of Business, etc.

21 Information to be stated in Package Insert

6 License of Manufacturing Business, etc. 14 License for Importing

Business 22 Cautions on Labeling

7 Conditional License 15 Notification of Repairing Business 23 Prohibited Labeling and

Advertising

8Re-examination of Newly Developed Medical Devices, etc.

16 Notification of Selling Business, etc. 23-2 Review of Advertisement

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Article Subject Article Subject Article Subject

24 General Prohibitions 32Cancellation of License, Suspension of Business, etc.

40 Succession to the status of Manufacturer, etc.

25 Medical device Subject to Tracking 33 Administrative Penalty 41 Renewal of Product

License or Notification

26 Record Keeping, Retention of Records, etc. 34 Hearing 42 Fees

27 Management of Adverse Events 35 Medical Device Surveillance

officer 43 Penalty

28 Report, Inspection, etc. 36Research and Development to Advance Medical device Industry

44 Penalty

45 Penalty

29 Order for Testing 37 Delegation and commission of Authorities 46 Parallel Punishments

30 Order for Destroy, etc. 38 Protection of Submitted Information 47 Administrative Fine

31 Order for cease of use, etc. 39 Special Measures for Veterinary devices Addendum

Each Articles Subjects of Medical Device Act

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No Product Group Applicable Product Designations (Examples)

1 Treatment table Operating and treatment table, Bed for medical use,Unit and chair, dental, Table and chair, examination/treatment, ENT

2 General Instrument Medical light and lamps, Neonatal incubator,Film developer for medical use

3 Metal sheet apparatus Medical sterilizing apparatus, Medical water sterilizers,Medical chamber, Blood bank refrigerator, Thermostat, liquid drug

4 Anesthesia apparatus Anesthesia apparatus, Respiratory apparatus

5 Artificial internal organ apparatus

Artificial internal organ apparatus(Cardiopulmonary bypass system, Pacemaker,Haemodialysis system, Cardiopulmonary bypass system roller pump, etc.)

6 Radiologic device CT system, full body, Mammographic x-ray system, PET system

7 Non-ionization diagnostic device MRI system, full-body, super conducting magnet

8 Radiation protective device

Radiation shield, spectacles,Radiation shielding apron

9 Physical devices for medical use

Stimulator, microwavephototherapy unit, ultravioletvelocitometer, Carvernosal artery

10 Cardiovascular devices Defibrillator, implantableBlood recovery collection container, auto transfusion

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Medical Device Products Group

No Product Group Applicable Product Designations (Examples)

11 Urology devicesLithotriptor, external ultrasonicLithoriptor, internal, laserIncontinence, diagnostic

12 Patient transportWheelchair, manually-operated lift, Patient transfer, electrically-poweredDisability scooter, automated

13 StethoscopeStethoscope, mechanicalultrasonic stethoscopeOesophageal stethoscope, mechanical

14 Clinical thermometricsystem

Thermometer, capillary, mercuryThermometer, colour-indicatingThermometer system, infrared

15 External diagnosticdevice

Flow type clinical chemistry automated analyzer.Calcium analyzer, CentrifugeDNA amplifier, Analyzer, blood gases

16 Perception and Organsdiagnostic devices

Sphygmomanometer, manual, aneroid sphygmographUrine analyzer, Electrocardiographic analyzer

17 Speculums for medical use

Adapter, endoscope elementStomatoscope, videoOesophagoscope, rigid/Laparoscope, flexible

Medical Device Products Group

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No Product Group Applicable Product Designations (Examples)

18 Surgical Instrument

Suture instrument only, reusablePnemothorax apparatus,Knife, manually-operated, reusable scissorscurettes, clamp, Forceps, Saw, chisel, Mallet

19 Electro surgical device Electro surgical system, general-purposeinstrument, ultrasonic surgical

20 Laser apparatusfor medical use

Laser, surgicalLaser surgical unit, Krypton

21 Needle for Syringes and puncture

Needle, aspiration/injection, reusableNeedle, artery, single-useLancet, automatic, single-use

22 SyringesInjector, medication/vaccine, syringeInjector, medication/vaccine, needleless, gas-poweredDental syringe

23 Infusion instrumentsCatheter, rectal, continent ileostomyCatheter, general-purpose, balloonblood collection container, Infusion pump

24 Medical device for orthopedics

Traction unit, manually-operated powered orthopedic devicevibrators for medical use

25 Dental deviceDental engineDental polymerization activator-ultravioletDental laboratory casting unit12

Medical Device Products Group

No Product Group Applicable Product Designations (Examples)

26 Sight corrective Lens Sight corrective spectacles, Trial lens

27 Hearing aid Hearing aid, bone-conductionImplantable hearing aid

28 Acupuncture andmoxibustion apparatus

Acupuncture needle, reusableMoxibustion apparatus, electrical

29Magnetic inductionapparatus for medical use

Magnetic pulse stimulatorElectromagnetic therapy stimulator

30 Medicinal substance-Producing equipment Alkali water producing equipment

31 Radiographic supplies X-ray film, medical, screenX-ray fluorescent screen

32 Suture and ligatureSilk suture, non-sterileSuture, cottonLigature, absorbable

33 Orthopedic materialsProsthesis, ankle, internal total Knee prosthesis, internal, totalOrthopedic bone screw, non-biodegradable

34 Human tissue and organ substitute

Prosthesis, Vascular, PeripheralCardiovascular patch, syntheticBreast prosthesis, internal, gel-filled

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Medical Device Products Group

No Product Group Applicable Product Designations (Examples)

35 SplintsSplints, general purposeSplints, Denis BrownSplints, extremity, inflatable

36Test chart for visualacuity and color blindness

Visual acuity chartcolor discrimination chart, ophtalmic

37 Contraceptive deviceContraceptive, condom, malePessaryContracoptive, intrauterine device

38 Surgical supplies Glove, surgicalBandage, Compression

39 Dental Materials

Alloy, foil, noble metalAlloy, metal-ceramic restorative systems, noble metalpure metal, filling, goldceramic, all-ceramic, powder/paste/blankMaterial, dentine, desensitizer

Medical Device Products Group

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Legal Metrology and Metrology System

Managing

measurement & metrology

Formulating policy

in measurement & metrology

OIML-MAA, ILAC-MRA

Legal metrology Measurement standard

Measure Act National Standards Act

KRISS

Establishment of thenational measurement standards

- Establishment & revision of verification standard

- Verification standard of

prepackaged good

• Type approval

• Verification• of manu-

facturing/importing

•Re-verification

KTC

Local government(234)

• Registration of manufactur

-ing & repair business

• Periodic inspection

• Surveillance of prepack

-aged goods

• Checking implementation

of SI unit use

KOLAS, KAS

KASTO

- Assessment body of KOLAS- Educational institution of

KOLAS & KAS

- Calibration lab (184) - Authorized testing lab (366)- Authorized inspection lab (44)

Assessment

KASTO

• Conformity of prepackagedgoods (k-mark)

• Training of government officials

ROTA

• Verifi-cation

of SPEEDGUN

KERI

• Type appro-valWattHour

meter

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Summary of Measures Act18 items of legal measuring instruments

(13 items for transactions, 2 items for medical use, 3 items for law enforcement)

Type Approval

Type Approval

• 18 items(by designated institution

OIML-MAA

18 items18 items

Instrument error inspection

Surveillance of local government

Verification

Prepackagedgoods

• 26 items of daily necessities

• allowed tolerance- managed by local government

• Self-declaration of conformity( -- mark)- managed by KASTO

Use of SI units

• Prohibited the use of non-SIunits (500,000 KRW Fine)

• Manufacturing and importing of non-SI unit measuring instruments(1 year prison or 5,000,000 KRW

Fine)

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What’s the global trend ?

Why we still need legal metrology control？

What are their differences ？

How to achieve complementary control ？

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Main Purposes of Regulatory ControlMedical Regulatory System1

• Ensure a high level of protection of public health and safety

• Public Trust and confidence in Medical Devices based on safety and performance of such devices Legal Metrology2

• Protect the interests of individuals and enterprises; national interests; public health and safety, including in relation to the environment and medical services; meet the requirements of international trade

• Providing confidence on Measurement Results of medical Device

1. Principles of Conformity Assessment for Medical Devices, SGI Final Document GHTF/SG1/N40：2006, Global Harmonization Task Force

2. Elements for a Law on Metrology, OIML D1,2004 edition

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Medical Regulatory Controls by RiskMedical regulatory controls are proportional to the level of risk associated with a medical device.

The level of regulatory control increases with increasing degree of risk

The risk depends substantially on• intended purpose of medical device• the effectiveness of the risk management techniques applied duringdesign, manufacture and use• Intended user(s).mode of operation, and/or technologies

Classification of Medical Device by Low risk, Low-moderate Risk,Moderate-high Risk, high risk (I, II, III, IV)

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Conformity Assessment Elements for Medical Device※

• Quality Management System

• Technical Documentation

Device safety and performance• Registration

※ Principles of Conformity Assessment for MedicalDevices, SGI Final Document GHTF/SG1/N40：2006

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Quality Management System• ISO 13485, 21 CFR Part 820 ……

• Ensure that medical devices will be safe and perform as intended by the manufacturer

• Type examination is acceptable in some cases

• System for post-market surveillance which includes complaint handling, post-market vigilance and corrective & preventive actions is required to ensure the continued conformity

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Sub-systems of Quality Management System• Management

• Design and Development

• Product Documentation

• Production and Process Controls

• Corrective and Preventive Actions (CAPA)

• Purchasing Controls

• Documentation and Records

• Customer Related Processes Subsystem22

Device safety and performance• Chemical, physical and biological properties.• Infection and microbial contamination.• Manufacturing and environmental properties.• Devices with a diagnostic or measuring function.• Protection against radiation.• Requirements for medical devices connected to or equipped with an energy source.• Protection against mechanical risks.• Protection against the risks posed to the patient by supplied energy orsubstances.• Protection against the risks posed to the patient for devices for self-testing or selfadministration.• Information supplied by the manufacturer.• Performance evaluation including, where appropriate, clinical evaluation

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Devices with a diagnostic or measuring functionDevices with a measuring function, where inaccuracy could have a significant adverse effect on the patient, should provide sufficient accuracy, precision and stability for their intended purpose of the device. The limits of accuracy should be indicated by the manufacturer.

Diagnostic devices should provide sufficient accuracy, precision and stability for their intended use, based on appropriate scientific and technical methods. In particular the design should address sensitivity, specificity, trueness, repeatability, reproducibility, control of known relevant interference and limits of detection, as appropriate

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The definition of Medical DeviceAny instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of such as

· diagnosis, prevention, monitoring, treatment oralleviation of disease,

· diagnosis, monitoring, treatment, alleviation of orcompensation for an injury, and so on …….

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Subject to legal metrology control• R7 Clinical thermometers, mercury-in-glass with maximum device• R16-1 Non-invasive mechanical sphygmomanometers• R16-2 Non-invasive automated sphygmomanometers• R26 Medical syringes• R78 Westergren tubes for measurement of erythrocyte sedimentation rate• R89 Electroencephalographs - Metrological characteristics - Methods and equipment for verification

• R90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification• R114 Clinical electrical thermometers for continuous measurement• R115 Clinical electrical thermometers with maximum device• R133 Liquid-in-glass thermometers• R135 Spectrophotometers for medical laboratories• Ophthalmic instruments – Impression and Applanation Tonometers Version 4 ,November 2009

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Controlled medical device

Medical regulatory control- By definition, cover extensively

Legal metrology control- Designated by legal metrology authority(only Thermometers , Sphygmomanometersare controlled by the Act in Korea)

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Conformity assessment

Medical regulatory control- By Risk

Legal metrology control- Uniformity- Risk assessment for metrological supervision

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Technical Requirements

Medical regulatory control- Extensively, cover safety and performance

issues

Legal metrology control- Accuracy(Safety, software identification, EMC, Clinicalevaluation: Control by Medical Device Act in Korea)

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The responsibilities of StakeholdersMedical regulatory controlRegulatory Authority：Review document and audit manufacturerManufacturer：Demonstrate safety and performance of medical device by establish and maintain QMS, prepare Technical Document, registration

Legal metrology controlRegulatory Authority：Verify every medical device usually by testing and evaluation

Manufacturer: have the device pattern approved, verified before placing on the market, registration

User：Maintain the accuracy of device30

Registration Design Manufacturing In Service

PRE-MARKERT POST MARKET

MedicalRegulatoryControl

•Manufacturer•Medical device

•QMS(ISO 13485)(Type Approval)•TechnicalDocumentation

•QMS•TechnicalDocumentation

•QMS

LegalMetrologyControl

•Manufacturer•Installer•Repairer

•Type Approval •Initialverification•(QMS, ISO 9000)

•Subsequentverification•Inspection•Marketsurveillance•Fieldsurveillance

Comparison Conformity Assessment Elements

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Complementary ControlUnderstand what medical regulatory system could reallycover in the Republic of Peru.

Identify the needs to undertake complementary control

• What is the type of medical device needed to be subjectto legal metrology control ？• What medical regulatory control can’t do？• Does management quality system ensure the continuedaccuracy of device in use ？

Avoid duplicate control

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