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Technical Briefing Seminar 25 November 2015 1 |
Medical Devices:
They Matter Too!
Josée Hansen Melissa Gómez
hansenj@who.int
November 2015
Technical Briefing Seminar 25 November 2015 2 |
Outline
Commonalities and differences between medicines
and medical devices
Status of medical device regulations worldwide
Model Regulatory Framework for medical devices
What do you think are the major challenges in
regulating medical devices?
Technical Briefing Seminar 25 November 2015 3 |
Do you know the acronyms?
IMDRF
DITTA
GMTA
ICH
Meddev
UMDNS
GMDN
INN
MDSAP
eCTD
IFPMA
PMS
RPS
Technical Briefing Seminar 25 November 2015 4 |
Medicinal product or medical device?
Condom
Pregnancy test
Artificial tears
Surgical gloves
Alcohol
A steriliser
Glucose 5%
Dialysis solution
Drug eluting stents
Deep brain stimulators
Microneedle patch with vaccine
Technical Briefing Seminar 25 November 2015 5 |
medicinal product medical device
Any substance or mixture of substances that is
manufactured for sale or distribution, sold, supplied, offered
for sale of presented for use in:
(i) the treatment, mitigation, cure , prevention or
diagnosis of disease, an abnormal physical state or the
symptoms thereof and abnormal physiological conditions in
human or animal; or
(ii) the restoration, correction or modification of organic
functions in human or animal.
… instrument, apparatus, implement, machine, appliance,
implant, reagent for in vitro use, software, material or other
similar or related article, intended by the manufacturer to be
used, alone or in combination, for human beings, for one or
more of the specific medical 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 by means of in vitro examination of
specimens derived from the human body;
-and does not achieve its primary intended action by
pharmacological, immunological or metabolic
means.
http://www.who.int/medicines/services/expertcommittees/pharmprep
/20111208_QASterminologyDB.pdf?ua=1 GHTF/SG1/N071:2012
Technical Briefing Seminar 25 November 2015 6 |
Commonalities and differences
Medicines Medical devices (+IVDs)
Diversity Approx. 40 NCE’s /year >>> 100,000; average
commercial life cycle 18 months
Innovation ‘Revolution’ Incremental improvement
Durability Single use Single use, multiple use,
permanent
Responsibilities Physician; pharmacist Usually not assigned
Context for use Independant Higly dependant
Clinical guidelines Detailed prescribed Not mentioned
Technical Briefing Seminar 25 November 2015 7 |
Commonalities and differences
Medicines Medical devices (+IVDs)
Benefit/risk assessment Each individual product Risk classes. Premarket
assessment of high risk medical
devices
Nomenclature International Non Proprietary
Name
GMDN
UMDNS
ISO 9999
UNSPSC
Others
Industry composition Dominated by large
multinationals; Small # of SMEs
Over 80% SMEs;
20 companies dominate sales
revenue
Sales global 900 billion US$ > 500 billion US$
Technical Briefing Seminar 25 November 2015 8 |
Regulation
Medicines Medical devices
Regulatory framework
All countries 55% of countries for MDs,
Less for IVDs
Medicines Medical devices
US
1937 1976
EU 1965 1993
Beginning of Regulatory Controls
Technical Briefing Seminar 25 November 2015 9 |
medicines medical devices
Number of guidance
documents
developed by WHO
• > 75 general QA standards,
good practices, guidelines
• 625 test specifications included
in the International
Pharmacopeia
• > 200 international chemical
reference standards
good review practices for
medicines and medical devices
blood products
< 10 guidelines IVDs as part of PQ
biotherapeutics including
vaccines
7 general documents for both
vaccines and biotherapeutics
8 general documents all vaccines
5 biotherapeutic specific
57 vaccine specific
Guidance by WHO
Technical Briefing Seminar 25 November 2015 10 |
Medicinal products Medical devices
efficacy safety and performance
interaction with the human body compatibility
placebo controlled and comparative studies clinical investigation
large numbers of patients included clinical evaluation
data not published
Clinical Trials
/blind.gif2http://www.thejabberwock.org/blog/ .html1_F2249/fig_tab/nm.11/n16http://www.nature.com/nm/journal/v
Performed by: Performed by:
Doctors Engineers
incremental improvements
Technical Briefing Seminar 25 November 2015 11 |
Marketing Authorisation
Medicinal products Medical devices
one single system concept of risk class: essential requirements applicable to
all risk classes
competent authority determines prescription status risk assessment by manufacturer
assessment of clinical trials bibliographic data
benefit / risk safe at the intended purpose; risk / benefit
Competent Authority, experts Conformity Assessment Bodies
national licenses for an established market Prioritization of products in an existing market
high threshold low threshold
Technical Briefing Seminar 25 November 2015 12 |
Medicinal products Medical devices
prescribing and dispensing strictly regulated prescribing and dispensing not regulated, linked to
professional skills
responsibility assigned no single responsibility assigned
efficacy is not dependent on context: skills and physical
environment
efficacy and effectiveness are context dependent
treatment guidelines available medical devices included in a treatment guideline to a
limited extend
effectiveness studies performed limited benefit / cost data
comparative studies; systematic reviews very limited data publicly available
Use
Technical Briefing Seminar 25 November 2015 13 |
Medicinal products Medical devices
pharmacovigilance legislation: new and detailed PMS system in legislation
responsibility of Marketing Authorisation Holder responsibility of manufacturer
reporting system regulated and well established not properly implemented by manufacturers and monitored
by authorities
effective? few data
Post Market Surveillance
Technical Briefing Seminar 25 November 2015 14 |
WHO Initiatives
Prequalification for IVDs – http://www.who.int/diagnostics_laboratory/evaluations/en/
Management in health care – http://www.who.int/medical_devices/management_use/en/
Regulation
Technical Briefing Seminar 25 November 2015 15 |
Medical products should be safe and
effective
Resolution WHA 67.20: Regulatory
System Strengthening for medical products
Member states request for support
on regulatory system
strengthening
Increasing importance of
medical devices: regulating an
existing market
Globalizing world
Lack of regulation in many member
states
Justification
)en.pdf21456en/s21456http://apps.who.int/medicinedocs/documents/s(
Technical Briefing Seminar 25 November 2015 18 |
Preliminary Results: Global Trends
N=194
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Low Income
Lower middle Income
Upper middle income
High Income
Regulatory Status of Medical Devices by Income Group
Countries that have Regulations Countries without regulations
23%
53%
55%
80%
57% 28%
15%
Countries with Regulations or Guidelines on Medical Devices
Countries with Regulations
Countries with no regulations
Data not available
Technical Briefing Seminar 25 November 2015 19 |
Preliminary Results: Regional Trends
N=194
47
23
5
12
9
14
6
12
6
15
12
33
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
EURO
AMRO
SEARO
WPRO
EMRO
AFRO
Regulatory Status of Medical Devices by Region
Countries with Regulations
Countries with no regulations
Technical Briefing Seminar 25 November 2015 20 |
Model Regulatory Framework
A Model Regulatory Framework for medical
devices including IVD’s with global input and
reflecting a modular approach in regulating
medical devices – How to begin regulating?
– What to regulate: harmonized definitions and guiding
principles
– How to regulate: stepwise development and
implementation
– When to regulate: priorities and transitional period
Technical Briefing Seminar 25 November 2015 21 |
Publications
http://new.paho.org/hq/dmdocuments/2009/AmodelRegulatoryProgramforMedicalDevices_AnInternal
Guide.pdf?ua=1
A Model Regulatory Program for Medical
Devices: An International Guide
2001 PAHO
http://apps.who.int/iris/bitstream/10665/42744/1/9241546182.pdf
Medical Device Regulations: Global
overview and guiding principles 2003 WHO
http://www.imdrf.org/docs/ghtf/final/steering-committee/technical-
docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf
The GHTF Regulatory Model 2011
http://www.ahwp.info/sites/default/files/ahwp-
files/8_Call_for_Comments/TCOB/AHWPTC_P01_2014.pdf
AHWP Playbook for implementation of
medical device regulatory
frameworks 2014
Technical Briefing Seminar 25 November 2015 22 |
What’s new?
Targeting member states with no or
limited regulations
• Emphasis should be put on market oversight
Priority setting in terms of regulation: stepwise approach
(basic, intermediate, full)
Reliance
• National competencies
Pre-requisites for developing and implementing
regulation
Technical Briefing Seminar 25 November 2015 23 |
The Model Regulatory Framework for medical
devices does not cover:
Establishing a single nomenclature system
Norms and standards for medical devices
Guidance on combination products
Financing of the regulatory system for medical devices
Technical Briefing Seminar 25 November 2015 25 |
Working Group Members
Mr. Abdullah S. AL-Dobaib
• Executive Director of Registration and Licensing,
Saudi Food and Drug Authority
Tuncay Bayrak
• Assistant Health Expert, Republic of Turkey Ministry of
Health Michael Gropp
Alan Kent
• Consultant
Agnes Kijo
• Manager, Medical Devices and Diagnostics Registration,
Tanzania Food and Drugs Authority (TFDA)
Niall MacAleenan
• Medical Device Lead/Clinical Asessment and Policy
Manager, Health Products Regulatory Authority, Ireland
Nancy Shadeed
• Special Advisor, Health Canada
Maura Linda Sitanggang/ Lupi Trilaksono
• Director General of Pharmaceutical Services and
Medical Devices, National Agency of Drug and Food
Control, Indonesia
Shelley Tang
• Stellar Consulting
Kim Trautman
• Associate Director, US Food and Drug Administration
Woei Jiuang Wong
• Director, Health Sciences Authority, Medical Device Branch, Health Products
Regulation Group, Singapore
Technical Briefing Seminar 25 November 2015 26 |
Technical Briefing Seminar 25 November 2015 28 |
Technical Briefing Seminar 25 November 2015 29 |
Stepwise Approach
Basic Elements
• Establishment of Essential Principles of Safety and Performance
• Issuing guidance documents on regulatory requirements
• Registration of manufacturers, importers and distributors
• Listing of medical devices placed on the market
• Import controls
• Market surveillance, supply chain control, traceability
• Labelling and instruction for use controls
• Serious adverse events, recalls, FSCAs or withdrawal from market in exchange with other NRAs
• Provision for exemptions from regulatory requirements e.g. donations and humanitarian use.
• Enforce regulations
Technical Briefing Seminar 25 November 2015 30 |
Stepwise Approach
Intermediate Elements
• QMS including good record keeping requirements
• Administrative controls for reliance
• Recognition and adoption of international standards
• Control of advertising
• Adverse event reporting within a vigilance system*
Full Implementation
• Premarket decision on compliance of medical device with essential principles (with reliance and/or review)
• Notification of clinical investigations and/or serious deviations and/or adverse events
• QMS auditing (by reliance and/or by auditing)
• Appoint and oversee CABs
• Establishment of a test laboratory function (national or regional or by reliance)
• Mechanism for analyses and dissemination of alerts on medical devices (national, regional, international)
Technical Briefing Seminar 25 November 2015 31 |
Basic Elements
58%
51%
65%
52%
60%
41%
57%
60%
23%
Essential principles
Labelling
Registration of Devices
Registration of Establishment
Import controls
Market surveillance
Adverse event reporting
Enforcement
FSCA Monitoring
Pre-Requisites
Pre-Market
Post-Market
N=110
Technical Briefing Seminar 25 November 2015 36 |
Questions?
In your opinion, what is the future of medical devices?
What can WHO do to take this further?
How can your organizations be involved?
How can the countries you represent benefit the most?
Technical Briefing Seminar 25 November 2015 44 |
Next steps and time line
First draft of the Model Regulatory Framework for medical
devices January 2015
Public Consultations in April and August
In parallel: regional awareness workshops
Under discussion: self assessments and capacity building
on request of member states
In parallel: NRA assessment if applicable
Technical Briefing Seminar 25 November 2015 45 |
Partners
Member States
IMDRF members
Asian Harmonization Working Party (AHWP)
Pan African Harmonization Working Party (PAHWP)
Regional Advisers
Experts
Other stakeholders (industry, consumers, NGO’s)
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