Overview of Registration in Juristic

CONFIDENTIAL
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Jan 2009
Overview
Overview of
of Medical
Medical
Device
Device Regulations
Regulations in
in
Established
Established Jurisdictions
Jurisdictions
Alfred Kwek
Deputy Director
Medical Device Branch
Health Sciences Authority
SINGAPORE
1
All Rights Reserved 2007 Health Sciences Authority
Outline
Regulatory frameworks
Classification of medical devices
Premarket requirements
Quality system requirements
Postmarket requirements
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MSc (Biomedical Engineering) M6505 Clinical Engineering All Rights Reserved, Health Sciences Authority, Singapore,
Jan 2009
1
CONFIDENTIAL
Devices
for the
Body
Copyright: The Straits Times, SPH
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GHTF Definition of a Medical Device (current)
“Medical device” means any instrument, apparatus, implement, machine,

appliance, implant, in vitro reagent or calibrator, software, material or
other similar or related article:-
a) intended by the manufacturer to be used, alone or in combination, for
human beings for one or more of the specific purpose(s) of:
· diagnosis, prevention, monitoring, treatment or alleviation of disease,
· diagnosis, monitoring, treatment, alleviation of or compensation for an
injury,
· investigation, replacement, modification, or support of the anatomy or of a
physiological process,
· supporting or sustaining life,
· control of conception,
· disinfection of medical devices,
· providing information for medical or diagnostic purposes by means of in
vitro examination of specimens derived from the human body;
Reference: GHTF/SG1/N29R16:2005, Information Document Concerning the Definition of the Term

"Medical Device"
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GHTF Definition of a Medical Device (current)
“Medical device” means any instrument, apparatus, implement, machine,

appliance, implant, in vitro reagent or calibrator, software, material or
other similar or related article:-
and
b) which does not achieve its primary intended action in or on the human
body by pharmacological, immunological or metabolic means, but which
may be assisted in its intended function by such means.
The definition of a device for in-vitro examination includes, for example,

reagents, calibrators, sample collection and storage devices, control
materials, and related instruments or apparatus. The information
provided by such an in-vitro diagnostic device may be for diagnostic,
monitoring or compatibility purposes.
Reference: GHTF/SG1/N29R16:2005, Information Document Concerning the Definition of the Term

"Medical Device"
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GHTF Member Jurisdictions

US, EU, Canada, Australia, Japan
Lithuania
Estonia
HANNOVER Scandinavia
Poland Latvia
LONDON ANTWERP
Czech Republic
Belgium Hungary
France BASEL
Turkey
Spain Greece
Iran China DENVER
Italy Israel
UAE Korea TOKYO
Saudi Arabia
Taiwan
India HONG KONG
Thailand Philippines Mexico

Malaysia Colombia
Brazil
Argentina
Chile
z SYDNEY
South Africa
Melbourne
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World Market Size 2000
Total: US$160 billion*

18 %
Rest of World
$34.5
26 %
billion EU
$41 billion
$24.5 billion
15 %
JPN $60 billion
41 %
USA
* Exclude IVDs (estimated at up to 17% Source:
of overall market value) EUCOMED & ADVAMED
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Singapore’s Market Size (Estimated)

for Medical Equipment & Devices 2000
Imports US$430 m
Local Production US$655 m
Exports 610 250 US$860 m
Local Use 180 45 US$225 m
0 200 400 600 800 1,000
Source: US$ million

US Department of Commerce
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USA
z 1976 Medical Device Amendments to FFD&C Act
z The Safe Medical Device Act 1990
z FDA Modernisation Act 1997
z Medical Device User Fee & Modernisation Act 2002
Medical EUROPEAN UNION

Device zz Active Implantable Medical Directive 1990
Medical Devices Directive 1993
Regulations z In-Vitro Diagnostics Directive 1998
OTHERS
z Therapeutic Goods Act 1989 (Australia)
z Therapeutic Goods (Medical Devices) Regulations 2002
(Australia)
z Medical Device Regulations 1998 (Canada)
z Pharmaceutical Affairs Law 1948,1960,1979,2002
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USA
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USA
Regulatory Framework
Regulatory agency: US Food and Drug Administration (FDA)
z Federal Food, Drug & Cosmetic (FFD&C) Act

z Medical Device Amendments of 1976 to FFD&C Act
z Medical Device Amendments of 1992 to FFD&C Act
z The Safe Medical Devices Act 1992
z FDA Modernisation Act 1997
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USA
Classification of Medical Devices

Risk based classification
Device classification depends on intended use and indications for use
Devices are classified into 3 classes, based on the level of control
needed to assure the safety and effectiveness of the device:
¾ Class I (Low risk) – General controls
• With exemptions
• Without exemptions
¾ Class II (Moderate risk) – General controls and special controls
• With exemptions
• Without exemptions
¾ Class III (High risk) – General controls and premarket approval
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USA
Premarket Requirements
Classification determines type of premarket

submission required for market clearance
Class I and II devices typically require premarket

notification (510k), unless exempt by regulation
Class III devices require submission of premarket

approval (PMA)
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USA
Class I
• General controls sufficient to provide reasonable assurance of safety
and effectiveness
• General controls:
Establishment registration
Medical device listing
Labelling requirements
Premarket notification (510k) submission
(unless exempted by regulations)
Manufacture under GMP requirements
(Note: All classes are subject to general controls)

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USA
Class II
General controls insufficient to provide reasonable
assurance of safety and effectiveness. In addition to
general controls, special controls are necessary
Special controls:
Special labelling requirements
Mandatory performance standards
Post market surveillance
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USA
Class III
General controls and special controls insufficient to
provide reasonable assurance of safety and effectiveness
Premarket approval (PMA) is required : scientific review to

ensure safety and effectiveness
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USA
Premarket notification (510k)

Premarket application to demonstrate that device is as safe and
effective i.e. substantially equivalent to a legally marketed device
(i.e. predicate device)
A device is substantially equivalent to a predicate device if it

• Has the same intended use and technological characteristics as
the predicate device
OR
• Has the same intended use as the predicate device and different
technological characteristics that do not raise new questions of
safety and effectiveness
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USA
Premarket Approval (PMA)

• Scientific review to evaluate the safety and effectiveness of
Class III devices.
• Sufficient valid scientific evidence to assure that the device is
safe and effective for its intended use must be submitted
• An approved PMA is, in effect, a private license granting the
applicant permission to market the device
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USA
Premarket Approval (PMA)

Review of a PMA is a 4 step review process consisting of:
• Administrative and limited scientific review by FDA staff to
determine completeness (filing review)
• In depth scientific and regulatory review by appropriate FDA
scientific and compliance personnel (in depth review)
• Review and recommendation by the appropriate advisory
committee (panel review)
• An FDA good manufacturing practices (GMP) inspection
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USA
Quality System Requirements
Quality system requirements are set out in the

Quality System Regulation
FDA does not require a manufacturer to register a
quality system (a requirement of ISO and EN quality
systems)
FDA inspects quality system requirements in the
course of regular inspections of a manufacturer’s
facilities
Foreign manufacturers are also subject to FDA
inspections
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USA
Postmarket Requirements
Requirements are set out in the Safe Medical Devices Act and
FDA Modernisation Act:
Manufacturers must submit medical device reports for device

which caused death or serious injury, or, if the malfunction were
to recur, would have cause death or serious injury
User facilities must report device related deaths and serious

injuries and submit a summary of all reports to FDA on an
annual basis
Manufacturers must have in place distribution records and other

methods for tracking permanent implants or life
sustaining/supporting devices used outside a facility
Manufacturers and importers must report to FDA any removals

and corrections of a device from the market
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European Union
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CONFIDENTIAL
EU
Medical Devices are regulated by three main Directives:
• Council Directive 90/385/EEC on Active Implantable Medical

Devices (AIMDD), 1990
• Council Directive 93/42/EEC on Medical Devices (MDD), 1992
• Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices

(IVDMD), 1998
EU member states transpose these directives into their national

laws
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EU
Classification of medical devices
Risk based and rules based classification
Medical devices are classified into 5 categories:

¾ Class I (Low risk)
¾ Class IIA (Low-moderate risk)
¾ Class IIB (Moderate-high risk)
¾ Class III (High risk)
¾ Active Implantable Medical Devices (AIMD)
Device class determines conformity assessment route
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EU
Each member state appoints a competent authority

(CA) to act as the State’s regulator and the CA in turn
appoints notified bodies (NB) to implement the
requirements of the directives (certification of CE
marking and quality systems)
NBs are typically test laboratories and quality

systems organizations
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EU
Directives define the essential requirements that devices have to
meet when they are put on the market or put into service (Annex I)
Directives contain a number of conformity assessment

procedures, which depend on the type of products and type of risks
involved (Annex II – VII)
Except for low risk devices, these procedures always involve

independent bodies, so-called Notified Bodies, designated and
monitored by national authorities. In a number of cases, authorities
act themselves as Notified Bodies
Compliance with harmonized European standards will provide a

presumption of conformity with the relevant essential requirements
Devices that meet the essential requirements and have undergone

the appropriate conformity assessment procedures will be CE
marked. The CE denotes a formal statement by the manufacturer of
compliance with the Directives’ requirements.
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EU
Quality system requirements are set out in the MDD

Annexes
The MDD requires quality systems to be registered to

a particular Annex of the MDD
Generally, notified bodies use ISO 13485 standard to

establish compliance with the quality system
requirements in a particular Annex
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EU
Manufacturer is required to establish and maintain a

system for reporting and acting upon incidents
affecting health and safety of patient or user
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Canada
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Canada
Regulatory agency: Health Canada
Food and Drugs Act, 1985

Medical Devices Regulations, 1998
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Canada
Risk based, rules based classification
Medical devices are classified into 1 of 4 classes: I, II,

III or IV. Class IV represents the highest risk
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Canada
All classes of devices must meet the following requirements:
Manufacturers must ensure that device meets safety and

effectiveness requirements in the Regulations and maintain
objective evidence as proof.
(Compliance with the safety and effectiveness requirements

can be demonstrated through the use of Health Canada
recognised standards.)
Any person who imports or sells a medical device and any

manufacturer who distributes directly to users must obtain an
establishment licence
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Canada
In addition,
Class II, III or IV devices:

¾ Device licence required prior to import and sales in Canada
¾ Class III and IV devices require scientific and medical

review of submitted evidence of safety and effectiveness
¾ Class II devices only require quality system audit
¾ Amount of information required to be submitted to obtain a

device licence increases as the risk class increases.
Class I devices:
¾ Exempt from device licensing requirements
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Canada
Quality system requirements
Manufacturers of Class II medical devices must have their

devices manufactured in accordance with the National Standard
of Canada CAN/CSA-ISO 13488-98, Quality Systems —
Medical devices — Particular requirements for the application of
ISO 9002,
Manufacturers of Classes III and IV medical devices must have

their devices designed and manufactured in accordance with the
National Standard of Canada CAN/CSA-ISO 13485-98, Quality
systems — Medical devices — Particular requirements for the
application of ISO 9001, as amended from time to time.
Quality system certificates to be issued by third party audit

organizations accredited by Standards Council of Canada and
recognized by Health Canada
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Canada
Postmarket requirements
Postmarket requirements apply to all classes of

devices:
• Maintaining distribution records of each device
• Mandatory problem reporting
• Recall
• Implant registration
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CONFIDENTIAL
Australia
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Australia
Regulatory Agency: Therapeutic Goods Administration (TGA)
Therapeutic Goods Act 1989

Therapeutic Goods Amendment (Medical Devices) Bill 2002
Therapeutic Goods (Medical Devices) Regulations 2002.
The new framework adopts the philosophies of the Global

Harmonisation Task Force on medical devices
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CONFIDENTIAL
Australia
Risk based, rules based classification
There are five classes of medical devices:

• Class I
• Class IIa
• Class IIb
• Class III
• Active Implantable Medical Devices (AIMD)
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Australia
The classification of a medical device determines the conformity

assessment procedure(s) a manufacturer can choose to ensure
that the device is adequately assessed to conform to the
essential principles of safety and performance defined in
Australian legislation
Higher class devices undergo a more stringent form of

conformity assessment than lower class devices
Depending on the procedure chosen, assessment of the final

design, the controls implemented for production and the
manufacturer’s courses of action may have to be assessed by
the TGA or another appropriate conformity assessment body.
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Australia
The following kind of medical device manufacturers are required under

Australian Legislation to obtain a Conformity Assessment Certificate
issued by TGA before the medical device can be included in the
ARTG:
All Australian manufacturers

Any manufacturer who manufactures medical devices containing
materials derived from animal, microbial or recombinant origin.
medicinal substances
blood plasma derivatives.
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Australia
Overseas manufacturers not belonging to one of the categories

described above and who hold current EC certification issued by
an EU Notified Body under the EU Medical Devices Directive
93/42/EEC (MDD) or the EU Active Implantable Medical
Devices Directive 90/385/EEC (AIMDD) are allowed, under
certain conditions, to use EC certificates to support an
application for inclusion in the ARTG. These manufacturers do
not require a Conformity Assessment Certificate to be issued by
the TGA prior to making an application to include the device in
the ARTG.
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Australia
Quality system requirements are set out in the

Regulations, under the various conformity
assessment routes
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Jan 2009
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CONFIDENTIAL
Australia
Vigilance System - Mandatory reporting system for adverse events
involving all medical devices. Based on recommendations of GHTF
Sponsors are required to report any problem to the manufacturer of

the device. Manufacturers are required to report the problem to the
TGA.
The Vigilance System comprises:

• penalties and time frames
• recall and seizure provisions
• voluntary reporting provisions for medical device users
• international information exchange between conformity
assessment bodies
• information exchange between inter governmental agencies
within Australia (such as Health Care Complaints Commission
and coronial inquests)
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Common Features
Level of regulatory scrutiny on a device depends on

the risk of harm that the device presents. The higher
the risk class of a device, the higher the level of
regulatory control
The safety and effectiveness of the device can be

assured through a balance of quality system
requirements, premarket scrutiny and postmarket
surveillance
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Jan 2009
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CONFIDENTIAL
Suggested Readings
www.fda.gov/cdrh (for medical devices)

www.fda.gov/cber (for biologics)(Biologics, in contrast to drugs
that are chemically synthesized, are derived from living sources (such as
humans, animals, and microorganisms)
www.ghtf.org (for best practices in medical device

regulations)
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48
All Rights Reserved 2006
2007 Health Sciences Authority
Jan 2009
24

Overview of Registration in Juristic

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CONFIDENTIAL

Copyright: The Straits Times, SPH

GHTF Definition of a Medical Device (current)

“Medical device” means any instrument, apparatus, implement, machine,

Reference: GHTF/SG1/N29R16:2005, Information Document Concerning the Definition of the Term

GHTF Definition of a Medical Device (current)

“Medical device” means any instrument, apparatus, implement, machine,

The definition of a device for in-vitro examination includes, for example,

Reference: GHTF/SG1/N29R16:2005, Information Document Concerning the Definition of the Term

GHTF Member Jurisdictions

 Thailand  Philippines  Mexico

World Market Size 2000

Total: US$160 billion*

Singapore’s Market Size (Estimated)

Local Production US$655 m

Exports 610 250 US$860 m

Local Use 180 45 US$225 m

0 200 400 600 800 1,000

Source: US$ million

Medical EUROPEAN UNION

Regulatory agency: US Food and Drug Administration (FDA)

z Federal Food, Drug & Cosmetic (FFD&C) Act

Classification of Medical Devices

 Classification determines type of premarket

 Class I and II devices typically require premarket

 Class III devices require submission of premarket

(Note: All classes are subject to general controls)

 Premarket approval (PMA) is required : scientific review to

Premarket notification (510k)

 A device is substantially equivalent to a predicate device if it

Premarket Approval (PMA)

Premarket Approval (PMA)

 Quality system requirements are set out in the

 Manufacturers must submit medical device reports for device

 User facilities must report device related deaths and serious

 Manufacturers must have in place distribution records and other

 Manufacturers and importers must report to FDA any removals

• Council Directive 90/385/EEC on Active Implantable Medical

• Council Directive 93/42/EEC on Medical Devices (MDD), 1992

• Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices

EU member states transpose these directives into their national

Classification of medical devices

 Risk based and rules based classification

 Medical devices are classified into 5 categories:

 Device class determines conformity assessment route

 Each member state appoints a competent authority

 NBs are typically test laboratories and quality

 Directives contain a number of conformity assessment

 Except for low risk devices, these procedures always involve

 Compliance with harmonized European standards will provide a

 Devices that meet the essential requirements and have undergone

Quality System Requirements

 Quality system requirements are set out in the MDD

 The MDD requires quality systems to be registered to

 Generally, notified bodies use ISO 13485 standard to

 Manufacturer is required to establish and maintain a

Regulatory agency: Health Canada

 Food and Drugs Act, 1985

Classification of Medical Devices

 Risk based, rules based classification

 Medical devices are classified into 1 of 4 classes: I, II,

 Manufacturers must ensure that device meets safety and

Thailand Philippines Mexico

Classification determines type of premarket

Class I and II devices typically require premarket

Class III devices require submission of premarket

Premarket approval (PMA) is required : scientific review to

A device is substantially equivalent to a predicate device if it

Quality system requirements are set out in the

Manufacturers must submit medical device reports for device

User facilities must report device related deaths and serious

Manufacturers must have in place distribution records and other

Manufacturers and importers must report to FDA any removals

Risk based and rules based classification

Medical devices are classified into 5 categories:

Device class determines conformity assessment route

Each member state appoints a competent authority

NBs are typically test laboratories and quality

Directives contain a number of conformity assessment

Except for low risk devices, these procedures always involve

Compliance with harmonized European standards will provide a

Devices that meet the essential requirements and have undergone

Quality system requirements are set out in the MDD

The MDD requires quality systems to be registered to

Generally, notified bodies use ISO 13485 standard to

Manufacturer is required to establish and maintain a

Food and Drugs Act, 1985

Risk based, rules based classification

Medical devices are classified into 1 of 4 classes: I, II,

Manufacturers must ensure that device meets safety and

Any person who imports or sells a medical device and any

Class II, III or IV devices:

Manufacturers of Class II medical devices must have their

Manufacturers of Classes III and IV medical devices must have

Quality system certificates to be issued by third party audit

Therapeutic Goods Act 1989

Risk based, rules based classification

There are five classes of medical devices:

The classification of a medical device determines the conformity

Higher class devices undergo a more stringent form of

Depending on the procedure chosen, assessment of the final

All Australian manufacturers

Overseas manufacturers not belonging to one of the categories

Quality system requirements are set out in the

Sponsors are required to report any problem to the manufacturer of

The Vigilance System comprises:

Level of regulatory scrutiny on a device depends on

The safety and effectiveness of the device can be

www.fda.gov/cdrh (for medical devices)

www.ghtf.org (for best practices in medical device