Safety - Global Harmonization Task Force Regulatory Framework

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 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
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Agenda
Global Harmonisation Task Force - Who is GHTF? - Current regulations in GHTF 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 / 3rd 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
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GHTF Members
5/ GE Title or job number / 11/23/2011
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
All Rights Reserved 2007 Health Sciences Authority
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USA
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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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)
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
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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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 manufacturers 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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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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EU
Each member state appoints a competent authority (CA) to act as the States 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

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: 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
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
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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 manufacturers 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. Any manufacturer who manufactures medical devices containing medicinal substances Any manufacturer who manufactures medical devices containing 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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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 & 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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Harmonized Approach
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 ?

42 / GE Title or job number / 11/23/2011
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? What is harmonization? ? What are we harmonizing?

Harmonization is NOT: A clone of each others regulations; and Recognition of each others 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

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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Identify & Overcome Issues & Challenges Tools - Common Dossiers
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Elements of CSDT (non-exhaustive)

Executive Summary Essential Principles Use of Standards Classification rules for MDs Labelling Verification & Validation Risk Analysis Manufacturer Information
Manufacturer Information
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Globalized manufacturing sites

USA
Monitor B888 Monitor C124
Finland
Monitor AB12 Monitor B82
Helsinki, Finland Milwaukee, USA Wuxi, China
Mexico
China
Accessories manufacturing
Mexico
Monitor V2B8
25 / GE /
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
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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.
Whats 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)
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Harmonization (revisit)
Quality Management System (QMS) Post-market Surveillance o Technical Documentation o Declaration of Conformity o Registration of manufacturers, distributors and their devices
Conformity Assessment Bodies (CABs)
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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
Conformity Assessment of QMS & Device

Conformity Assessment of Manufacturers 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

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Accreditation of Conformity Assessment Bodies

For example: Assessment of Technical Competence Product knowledge Clinical experience Regulatory knowledge Auditing experience
Ensuring Competency
Conformity Assessment Bodies Manufacturers Distributors Hospitals, clinics, retail
Upstream Midstream Downstream
Accreditation of Conformity Assessment Bodies

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Quality Management System (QMS) Post-market Surveillance o Technical Documentation o Declaration of Conformity o Registration of manufacturers, distributors and their devices
Identify & Overcome Issues & Challenges Tools Grouping of Medical Devices
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Wide Range of Device Types Different from Drugs

Orthopedic General & Plastic Surgery Cardiovascular Radiology General Hospital Dental Clinical Chemistry Anesthesiology Gastroenterology / Urology Neurology
Microbiology Physical Medicine Ob / Gyn Ophthalmic Immunology Hematology Ear Nose & Throat Toxicology Pathology
Clinical breadth & depth of device use in the hospital

Emergency Radiology Perioperative Critical Care Progressive Care MaternalInfant Outpatient Doctor Office
Patient Monitors
Critical Care Ventilators
ED
Supplies & Accessories
Cath/EP Lab
OR
ICU
Networking Systems & Interfacing
CIS & Mgt. Software
Telemetry
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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
Dental Hand Piece
Dental Burrs Dental Anchors
Source: HSA, Singapore

Med Dev & Accessories in Use

Near the Bedside (Displays) Where Convenient (CPU)
Close to the Patient (Modules)
Patient Specific (Supplies & Accessories)
Monitor Needs Accessories to Function

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Medical Devices: Spare Parts for Ourselves

Copyright: The Straits Times, SPH
Medical Devices Requires Spare Parts too!
X-Ray tube
Source: http://www.hcstarck.com/
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Globalized manufacturing sites

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

Stakeholders
Hospitals / Clinics / Users
People
Device Regulators Non-MOH Regulators
Manufacturers
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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 Physicians influence on clinical outcome Risk sharing during device use
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

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Implement MD regulatory system Declaration of Conformity (legal attestation) Registration of manufacturers, distributors and their devices (MD
regulatory control regime)
Meeting Theme and Objectives (revisit)

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
37 / GE /
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
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
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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
Conclusion
Tools of Harmonization Common Dossiers, Grouping - Use of international Standards / local standards) - Outsourced / 3rd 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)
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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)
Thank You
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Safety - Global Harmonization Task Force Regulatory Framework

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

Global Harmonization Task Force Regulatory Framework

Meeting Theme and Objectives

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

Medical Device Regulations in GHTF Members

All Rights Reserved 2007 Health Sciences Authority

Classification of Medical Devices

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Quality System Requirements

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

EU member states transpose these directives into their national laws

All Rights Reserved 2007 Health Sciences Authority

Classification of medical devices

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Quality System Requirements

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Classification of Medical Devices

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Quality system requirements

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Classification of Medical Devices

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

All Rights Reserved 2007 Health Sciences Authority

Quality System Requirements

All Rights Reserved 2007 Health Sciences Authority

Common & Uncommon Features

All Rights Reserved 2007 Health Sciences Authority

? What is harmonization ? ? What are we harmonizing ?

? What is harmonization? ? What are we harmonizing?

Distilling and harmonizing technical elements within Regulations

GHTF Definition of a Medical Device

GHTF Definition of a Medical Device

Identify & Overcome Issues & Challenges Tools - Common Dossiers

Elements of CSDT (non-exhaustive)

Globalized manufacturing sites

Helsinki, Finland Milwaukee, USA Wuxi, China

49 / GE Title or job number / 11/23/2011

50 / GE Title or job number / 11/23/2011

ISO 13485 Certificate

51 / GE Title or job number / 11/23/2011

52 / GE Title or job number / 11/23/2011

53 / GE Title or job number / 11/23/2011

Whats Does it Mean?

55 / GE Title or job number / 11/23/2011

Conformity Assessment Bodies (CABs)

GHTF Definition of CABs