medical devices: how interesting they are! · maura linda sitanggang/ lupi trilaksono •director...

Technical Briefing Seminar 20 October 2016 1 |

Medical Devices:

how interesting they are!

Josée Hansen

[email protected]

20 October 2016


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?


Take home message


Some questions

Thinking of medical devices…

How do I know they are safe?

Are they tested before being placed on the market?

Who can I ask when I have questions?

Does the doctor know how to use a device safely?

Adverse events: where to go?


Medicinal product or medical device?

Condom

Pregnancy test

Artificial tears

Surgical gloves

Alcohol

A steriliser

Glucose 5%

Dialysis solution

Drug eluting stents

Microneedle patch with vaccine


Definitions

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.


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


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$


Regulation

Medicines Medical devices

Regulatory framework

All countries 58% of countries for MDs, Less for IVDs

Medicines Medical devices

US

1937 1976

EU 1965 1993

Beginning of Regulatory Controls


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


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


Marketing Authorisation


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



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



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


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


WHO Mandate

WHA 67.20 Regulatory System Strengthening for medical

products

– … to prioritize support for establishing and strengthening

regional and subregional networks of regulatory

authorities, as appropriate, including strengthening areas

of regulation of health products that are the least

developed, such as regulation of medical devices,

including diagnostics;

http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf





Global Survey on the Status of Medical Device Regulations | 29-30 September 2015 17 |

Regulatory status: global


Regulatory status by region

N=194

15

23

10

48

5

12

19

6

10

3

3

12

13

6

1

2

3

3

AFRO

AMRO

EMRO

EURO

SEARO

WPRO

Number of countries

WH

O r

egio

ns

Regulatory Status of Medical Devices by Region

Countries withRegulations

Countries withoutRegulations

Data not available


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


WHO Global Model


Working Group


Target audience

Countries with no or limited regulatory framework in place

With the ambition to improve this situation

The legislative, executive and regulatory branches of

government


Convergence and harmonization

Convergence and harmonization

– Definition of a medical device

– Classification of medical devices

– Essential principles of safety and performance

– QMS

– Standards

– …

Confidence building and Information sharing

Reliance and recognition


Two steps approach

Basic level controls and enforcement

– Legal framework

– Market oversight

– Reporting system

Expanded level controls and enforcement

– regulatory controls depending on the priorities of the country


Regulating medical devices - challenges

Less developed regulatory systems than for vaccines and

medicines, particularly in LIMC’s

Lack of awareness

Characteristics of medical devices as a product group

Regulating in an existing market

Lack of specialized knowledge and resources to draft and

implement medical devices regulations

Lack of resources


Good regulatory practices

Critical elements for regulating medical devices

– Political commitment

– Legal framework

– Implementation plan

– Competent authority with enforcement power

– Involvement of stakeholders

– Transparent and impartial

Importance of convergence, harmonization, reliance and

recognition


Take home message


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?


Thank you very much


Objective of the WHO Global Model

A Model Regulatory Framework for medical devices

including IVDs with global input and reflecting a modular

approach in regulating medical devices to be used by

national regulatory agencies in order to formulate laws and

regulations to define and control the national market in

medical devices in the interest of public health


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


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.w ho.int/iris/bitstream/10665/42744/1/9241546182.pdf

Medical Device Regulations: Global

overview and guiding principles 2003 WHO

http://w w w.imdrf.org/docs/ghtf/f inal/steering-committee/technical-

docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf

The GHTF Regulatory Model 2011

http://w w w.ahwp.info/sites/default/f iles/ahw p-

f iles/8_Call_for_Comments/TCOB/AHWPTC_P01_2014.pdf

AHWP Playbook for implementation of

medical device regulatory

frameworks 2014


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


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


Do you know the acronyms?

IMDRF

DITTA

GMTA

ICH

Meddev

UMDNS

GMDN

INN

MDSAP

eCTD

IFPMA

PMS

RPS

medical devices: how interesting they are! · maura linda sitanggang/ lupi trilaksono •director...

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