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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

GE Healthcare Global Harmonization Task Force Regulatory Framework Alfred KWEK Director, Regulatory Affairs, ASEAN GE
GE Healthcare
Global Harmonization Task Force Regulatory Framework
Alfred KWEK
Director, Regulatory Affairs, ASEAN
GE Healthcare
Medical Device Regulatory Conference, Langkawi, Malaysia, 24 Nov 2011

Meeting Theme and Objectives

Theme

Transforming Malaysia as a Medical Device Hub Through Harmonized Regulatory Approach

Objectives

To promote medical device industry in Malaysia To create awareness among stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry

stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
on policy and regulatory requirements To identify and overcome issues and challenges in medical industry 1

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Agenda

Global Harmonisation Task Force

- Who is GHTF?

- Current regulations in GHTF members

- Understand recipient / importing market requirements

Harmonized Regulatory Approach

- What is harmonization?

members - Understand recipient / importing market requirements Harmonized Regulatory Approach - What is harmonization?

Agenda

Identify & Overcome Issues and Challenges

Tools – Common Dossiers

- Common Submission Dossier Template (CSDT)

- Global / 3 rd party manufacturing sites

- Quality management systems (QMS)

Tools – Grouping of Devices

- Systems, Groups, Families, Spare Parts,

Expendables

- Registration of devices

- Import and local supply of medical devices

Families, Spare Parts, Expendables - Registration of devices - Import and local supply of medical devices

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

GHTF Members

GHTF Members 5 / GE Title or job number / 11/23/2011
GHTF Members 5 / GE Title or job number / 11/23/2011

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Medical Device Regulations in GHTF Members USA 1976 Medical Device Amendments to FFD&C Act The
Medical Device Regulations in GHTF Members
USA
1976 Medical Device Amendments to FFD&C Act
The Safe Medical Device Act 1990
FDA Modernisation Act 1997
Medical Device User Fee & Modernisation Act 2002
EUROPEAN UNION
Active Implantable Medical Directive 1990
Medical Devices Directive 1993
In-Vitro Diagnostics Directive 1998
OTHERS
Therapeutic Goods Act 1989 (Australia)
Therapeutic Goods (Medical Devices) Regulations 2002 (Australia)
Medical Device Regulations 1998 (Canada)
Pharmaceutical Affairs Law 1948,1960,1979,2002
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(Canada) Pharmaceutical Affairs Law 1948,1960,1979,2002 6 All Rights Reserved 2007 Health Sciences Authority 3 / /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

USA 7 All Rights Reserved 2007 Health Sciences Authority
USA
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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:

Class I (Low risk) – General controls

• With exemptions

• Without exemptions

Class II (Moderate risk) – General controls and special controls

• With exemptions

• Without exemptions

Class III (High risk) – General controls and premarket approval

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(High risk) – General controls and premarket approval All Rights Reserved 2007 Health Sciences Authority 8

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

 

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

 

Premarket Requirements

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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to general controls)     1 0 All Rights Reserved 2007 Health Sciences Authority   5

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

USA

Premarket Requirements

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

Premarket requirements

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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scientific review to ensure safety and effectiveness All Rights Reserved 2007 Health Sciences Authority 1 2

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

USA

Premarket requirements

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 requirements

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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the applicant permission to market the device All Rights Reserved 2007 Health Sciences Authority 1 4

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

USA

Premarket requirements

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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are also subject to FDA inspections   1 6 All Rights Reserved 2007 Health Sciences Authority

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

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 18 All Rights Reserved 2007 Health Sciences Authority
European Union
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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

 

EU

Regulatory Framework

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:

Class I (Low risk) Class IIA (Low-moderate risk) Class IIB (Moderate-high risk) Class III (High risk) Active Implantable Medical Devices (AIMD)

Device class determines conformity assessment route

 

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

 

EU

 

Premarket Requirements

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

 

Premarket Requirements

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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with the Directives’ requirements.   2 2 All Rights Reserved 2007 Health Sciences Authority 11 /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

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EU

Quality System Requirements

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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quality system requirements in a particular Annex All Rights Reserved 2007 Health Sciences Authority 2 4

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

EU

Postmarket Requirements

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 26 All Rights Reserved 2007 Health Sciences Authority
Canada
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Reserved 2007 Health Sciences Authority 2 5 Canada 26 All Rights Reserved 2007 Health Sciences Authority

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Canada

Classification of Medical Devices

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

Premarket requirements

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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to users must obtain an establishment licence All Rights Reserved 2007 Health Sciences Authority 2 8

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

 

Canada

Premarket requirements

In addition,

Class II, III or IV devices:

Device licence required prior to import and sales in Canada

Class III and IV devices require scientific and medical review of submitted evidence of safety and effectiveness

Class II devices only require quality system audit

Amount of information required to be submitted to obtain a device licence increases as the risk class increases.

Class I devices:

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 and recognized by Health Canada   3 0 All Rights Reserved 2007 Health Sciences Authority

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

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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Australia 32 All Rights Reserved 2007 Health Sciences Authority
Australia
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Reserved 2007 Health Sciences Authority 3 1 Australia 32 All Rights Reserved 2007 Health Sciences Authority

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

 

Australia

 

Classification of Medical Devices

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

 

Premarket Requirements

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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appropriate conformity assessment body.   3 4 All Rights Reserved 2007 Health Sciences Authority 17 /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

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Australia

Premarket requirements

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. Any manufacturer who manufactures medical devices containing medicinal substances Any manufacturer who manufactures medical devices containing blood plasma derivatives.

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medical devices containing blood plasma derivatives. All Rights Reserved 2007 Health Sciences Authority 3 6 18

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Australia

Premarket Requirements

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

Quality system requirements are set out in the Regulations, under the various conformity assessment routes

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Australia

Postmarket Requirements

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 & Uncommon Features

Devices classified according to risk- level of regulatory scrutiny on a device depends on the risk of harm that the device presents. Higher risk class; higher level of control

Safety and effectiveness of the device can be assured through a balance

• Quality system requirements

• Pre-market requirements & scrunity

• Post-market surveillance system & obligations

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Post-market surveillance system & obligations All Rights Reserved 2007 Health Sciences Authority 4 0 20 /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Harmonized Approach

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Harmonization

Quality Management System (QMS)

Post-market Surveillance

Technical Documentation

Declaration of Conformity

Registration of manufacturers, distributors and their devices

? What is harmonization ? ? What are we harmonizing ?

and their devices ? What is harmonization ? ? What are we harmonizing ? 42 /

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devices ? What is harmonization ? ? What are we harmonizing ? 42 / GE Title

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

? What is harmonization? ? What are we harmonizing?

Harmonization is NOT:-

A clone of each other’s regulations; and

Recognition of each other’s regulations or approval.

Harmonization is:-

A process of sharing;

Agreeing (and disagreeing) on best practices within regulatory control regime for MD; and

Achieving a least burdensome regulatory pathway to market(s) as a desired outcome.

Distilling and harmonizing technical elements within Regulations

desired outcome. Distilling and harmonizing technical elements within Regulations 43 / GE Title or job number

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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"

Document Concerning the Definition of the Term "Medical Device" 44 / GE Title or job number

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the Definition of the Term "Medical Device" 44 / GE Title or job number / 11/23/2011

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

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"

Document Concerning the Definition of the Term "Medical Device" 45 / GE Title or job number

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Identify & Overcome Issues & Challenges Tools - Common Dossiers

Identify & Overcome Issues & Challenges Tools - Common Dossiers
Title or job number / 11/23/2011 4 Identify & Overcome Issues & Challenges Tools - Common

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Elements of CSDT (non-exhaustive)

• Executive Summary

• Essential Principles

Use of Standards

• Classification rules for MDs

Labelling

• Verification & Validation

• Risk Analysis

Manufacturer Information

• Verification & Validation • Risk Analysis • Manufacturer Information 47 / GE Title or job

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Manufacturer Information

Manufacturer Information
Analysis • Manufacturer Information 47 / GE Title or job number / 11/23/2011 Manufacturer Information 24

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Globalized manufacturing sites

USA Finland Monitor B888 Monitor AB12 Monitor C124 Monitor B82 Helsinki, Finland Milwaukee, USA Wuxi,
USA
Finland
Monitor B888
Monitor AB12
Monitor C124
Monitor B82
Helsinki, Finland
Milwaukee, USA
Wuxi, China
China
Mexico
Accessories
Mexico
manufacturing
Monitor V2B8
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Monitor V2B8 49 / GE Title or job number / 11/23/2011 50 / GE Title or

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

ISO 13485 Certificate

LNE certifies….

GE Medical Systems

For the activities

Design and configuration of cardiology equipment…

Performed on the location of

GE Medical Systems

Complies with the requirements of the international standards

ISO 9001:2008 – ISO 13485:2003

This certificate is issued according to the rules of G-Med certification

G-Med Notified Body for Medical Devices

to the rules of G-Med certification • G-Med Notified Body for Medical Devices 51 / GE

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for Medical Devices 51 / GE Title or job number / 11/23/2011 52 / GE Title

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

EC Certificate

EC Certificate

Approval full Quality Assurance System

Annex II section 3 Directive 93/42/EEC concerning medical devices

Manufacturer

GE Hangwei Medical Systems

Device category

CT Scanners – MRI systems

G-Med certifies that, on the basis of the results contained in the file referenced J018084-R, the quality system – for design, manufacturing, and final inspection – of medical devices listed here above complies with the requirements of the Directive 93/42/EEC, annex II section 3.

complies with the requirements of the Directive 93/42/EEC, annex II section 3. 53 / GE Title

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What’s Does it Mean?

As an example

• What are the meanings behind the wordings of the certificate?

• Notified Body (CE XXXX) issues a certificate. It means

that:-

manufacturer has maintained a QMS that meets the ISO 13485:2003 standard; and meets EU Medical Device Directive

(93/42/EEC) that meets the ISO 13485:2003 standard; and meets EU Medical Device Directive 54 / GE Title

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and meets EU Medical Device Directive (93/42/EEC) 54 / GE Title or job number / 11/23/2011

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Harmonization (revisit)

Quality Management System (QMS) Post-market Surveillance

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Technical Documentation

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Declaration of Conformity

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Registration of manufacturers, distributors and their devices

Conformity o Registration of manufacturers, distributors and their devices 55 / GE Title or job number

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Conformity Assessment Bodies (CABs)

Conformity Assessment Bodies (CABs)
and their devices 55 / GE Title or job number / 11/23/2011 Conformity Assessment Bodies (CABs)

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

GHTF Definition of CABs

GHTF Definition of Conformity Assessment Body (CAB):

a body engaged in the performance of procedures for determining whether the relevant requirements in technical regulations or standards are fulfilled. A CAB is authorised to undertake specified conformity assessment activities by a Regulatory Authority (RA) that will ensure performance of the CAB is monitored and if necessary withdraw designation

ensure performance of the CAB is monitored and if necessary withdraw designation 57 / GE Title

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Conformity Assessment of QMS & Device

Conformity Assessment of Manufacturer’s QMS

• Audits of the QMS

• Audits of the Post Market Surveillance process

Conformity Assessment of the Device Safety and Performance

• Review of device product technical documentation in dossier

Review of Declaration of Conformity

product technical documentation in dossier Review of Declaration of Conformity 58 / GE Title or job

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documentation in dossier Review of Declaration of Conformity 58 / GE Title or job number /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Accreditation of Conformity Assessment Bodies

For example: Assessment of Technical Competence

Product knowledge Clinical experience Regulatory knowledge Auditing experience

knowledge Clinical experience Regulatory knowledge Auditing experience 59 / GE Title or job number / 11/23/2011

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Ensuring Competency

 

Conformity Assessment Bodies

Upstream

Manufacturers

Midstream

Distributors

Downstream

Hospitals, clinics, retail

Accreditation of Conformity Assessment Bodies

Hospitals, clinics, retail Accreditation of Conformity Assessment Bodies 60 / GE Title or job number /

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retail Accreditation of Conformity Assessment Bodies 60 / GE Title or job number / 11/23/2011 30

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Harmonization (revisit)

Quality Management System (QMS) Post-market Surveillance

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Technical Documentation

o

Declaration of Conformity

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Registration of manufacturers, distributors and their devices

Conformity o Registration of manufacturers, distributors and their devices 61 / GE Title or job number

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Identify & Overcome Issues & Challenges Tools – Grouping of Medical Devices

Identify & Overcome Issues & Challenges Tools – Grouping of Medical Devices
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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Wide Range of Device Types – Different from Drugs

Orthopedic General & Plastic Surgery Cardiovascular Radiology General Hospital Dental Clinical Chemistry Anesthesiology Gastroenterology / Urology Neurology

Anesthesiology Gastroenterology / Urology Neurology Microbiology Physical Medicine Ob / Gyn Ophthalmic

Microbiology Physical Medicine Ob / Gyn Ophthalmic Immunology Hematology Ear Nose & Throat Toxicology Pathology

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Clinical breadth & depth of device use in the hospital

Progressive Progressive Maternal- Maternal- Doctor Doctor EmergencyEmergency RadiologyRadiology
Progressive
Progressive
Maternal-
Maternal-
Doctor
Doctor
EmergencyEmergency
RadiologyRadiology
PerioperativePerioperative
CriticalCritical CareCare
OutpatientOutpatient
Care
Care
Infant
Infant
Office
Office

Cath/EP Lab

Care Care Infant Infant Office Office Cath/EP Lab OR ICU 64 / GE Title or job

OR

ICU

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Patient Patient Monitors Monitors Critical Care Critical Care Ventilators Ventilators ED Supplies & Supplies
Patient
Patient
Monitors
Monitors
Critical Care
Critical Care
Ventilators
Ventilators
ED
Supplies &
Supplies &
Accessories
Accessories
Networking
Networking
Systems
Systems
&
&
Interfacing
Interfacing
Telemetry
CIS & Mgt.
CIS & Mgt.
Software
Software
Systems & & Interfacing Interfacing Telemetry CIS & Mgt. CIS & Mgt. Software Software 32 /

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Med Devices & Accessories

Total Knee Replacement System – Different from Drugs

• Femoral component (various size)

• Tibial plate (various size)

• Tibial insert (various size)

• Instrumentation (e.g. retractors)

Femoral component Tibial insert Tibial plate
Femoral
component
Tibial insert
Tibial plate
retractors) Femoral component Tibial insert Tibial plate Dental Hand Piece Dental Burrs Dental Anchors Source: HSA,

Dental Hand Piece retractors) Femoral component Tibial insert Tibial plate Dental Burrs Dental Anchors Source: HSA, Singapore 65 /

component Tibial insert Tibial plate Dental Hand Piece Dental Burrs Dental Anchors Source: HSA, Singapore 65

Dental Burrs

Tibial insert Tibial plate Dental Hand Piece Dental Burrs Dental Anchors Source: HSA, Singapore 65 /

Dental Anchors

Source: HSA, Singapore

65 /

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Med Dev & Accessories in Use

(CPU)
(CPU)

Near the Bedside (Displays)

Where Convenient

Close to the Patient (Modules)
Close to the Patient
(Modules)
(Displays) Where Convenient Close to the Patient (Modules) Patient Specific (Supplies & Accessories) 66 / GE

Patient Specific (Supplies & Accessories)

(Modules) Patient Specific (Supplies & Accessories) 66 / GE Title or job number / 11/23/2011 Monitor
(Modules) Patient Specific (Supplies & Accessories) 66 / GE Title or job number / 11/23/2011 Monitor

66 /

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Monitor Needs Accessories to Function

Specific (Supplies & Accessories) 66 / GE Title or job number / 11/23/2011 Monitor Needs Accessories
& Accessories) 66 / GE Title or job number / 11/23/2011 Monitor Needs Accessories to Function

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Medical Devices: Spare Parts for Ourselves Copyright: The Straits Times, SPH 67 / GE Title

Medical

Devices:

Spare Parts for Ourselves

Copyright: The Straits Times, SPH

67 / GE Title or job number /

11/23/2011

X - R a y t u b e Medical Devices Requires Spare Parts too!

X-Ray tube

Medical Devices Requires Spare Parts too!

Source: http://www.hcstarck.com/

X - R a y t u b e Medical Devices Requires Spare Parts too! Source:

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Globalized manufacturing sites

USA Finland Monitor B888 Monitor AB12 Monitor C124 Monitor B82 Helsinki, Finland Milwaukee, USA Wuxi,
USA
Finland
Monitor B888
Monitor AB12
Monitor C124
Monitor B82
Helsinki, Finland
Milwaukee, USA
Wuxi, China
China
Mexico
Accessories
Mexico
manufacturing
Monitor V2B8
Globalization: A necessary pain
69 /
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11/23/2011

Stakeholders

Hospitals / Clinics / Users

People
People

Device Regulators Non-MOH Regulators

Manufacturers

/ Clinics / Users People Device Regulators Non-MOH Regulators Manufacturers 70 / GE Title or job

70 /

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People Device Regulators Non-MOH Regulators Manufacturers 70 / GE Title or job number / 11/23/2011 35

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Facts About MD & the Industry

• Wide range of device types

• Many different areas of clinical use

• Accessories (sometimes disposable) critical to device use

• Import of spare parts / expendables

• Globalization and global manufacturing sites

• Physician’s influence on clinical outcome

• Risk sharing during device use

Physician’s influence on clinical outcome • Risk sharing during device use 71 / GE Title or

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Harmonization (revisit)

Quality Management System (QMS) Post-market Surveillance Technical Documentation

- review sample device label

o

Declaration of Conformity

o

Registration of manufacturers, distributors and their devices

Conformity o Registration of manufacturers, distributors and their devices 72 / GE Title or job number

72 /

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Registration of manufacturers, distributors and their devices 72 / GE Title or job number / 11/23/2011

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Harmonization (revisit)

Implement MD regulatory system

Registration of manufacturers, distributors and their devices (MD

Declaration of Conformity (legal attestation)

regulatory control regime)

(MD Declaration of Conformity (legal attestation) regulatory control regime) 73 / GE Title or job number

73 / GE Title or job number /

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Meeting Theme and Objectives (revisit)

Theme

Meeting Theme and Objectives (revisit) Theme Transforming Malaysia as a Medical Device Hub Through Harmonized

Transforming Malaysia as a Medical Device Hub Through Harmonized Regulatory Approach

Objectives

To promote medical device industry in Malaysia To create awareness among stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry

stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
stakeholders on policy and regulatory requirements To identify and overcome issues and challenges in medical industry
on policy and regulatory requirements To identify and overcome issues and challenges in medical industry 37

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Least Burdensome Regulatory Pathway

Import of Medical Devices

Harmonized System (HS) Codes mapped to medical device registrations / product codes

Licensed entities permitted to import devices (incl. accessories/spare parts) they have registered

permitted to import devices (incl. accessories/spare parts) they have registered 75 / GE Title or job

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Least Burdensome Regulatory Pathway

Import of Accessories

Import of accessories separately from main device permitted as part of the approved license; no separate import license for accessories needed Facilitation of separate import of accessories

Import of Spare Parts

Import permitted as part of the approved medical device license; no separate import license for spare parts needed

medical device license; no separate import license for spare parts needed 76 / GE Title or

76 /

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device license; no separate import license for spare parts needed 76 / GE Title or job

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Conclusion

Global Harmonization Task Force

- What is GHTF & their current regulations?

Harmonization

- What is / what is not harmonization?

Tools of Harmonization – Common Dossiers, Grouping

- Tools to be used for registration

Tools to be used for designing a regulatory framework that is least burdensome

-

- Tools to be used for registration Tools to be used for designing a regulatory framework

Conclusion

Tools of Harmonization – Common Dossiers, Grouping

- Use of international Standards / local standards)

- Outsourced / 3 rd party manufacturing sites

- Clarity in grouping rules (affects registration fees)

- Grouping affects multi-country use of CSDT

- Inclusion of accessories codes into CSDT (affects Import and supply of accessories)

- Import and supply of spare parts / expendables (affects local supply)

CSDT (affects Import and supply of accessories) - Import and supply of spare parts / expendables
Import and supply of accessories) - Import and supply of spare parts / expendables (affects local

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Presentation at Malaysia Medical Device Regulatory Conference Langkawi, Malaysia - 24 Nov 2011

Conclusion

Recommendations

- Aware of need to map against other regulatory elements and guidance documents for setting up a harmonized regulatory

framework (e.g. registration of manufacturers and listing of medical device, definition of MD, classification of MD, definition of manufacturers, authorized representatives)

of medical device, definition of MD, classification of MD, definition of manufacturers, authorized representatives)

Thank You

Thank You
definition of MD, classification of MD, definition of manufacturers, authorized representatives) Thank You 40 / /

40 /

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