REGULATION OF MEDICAL DEVICES INNOVATION TUĞÇE YAŞAR 290707001.
Governmental Regulation of Medical Devices
-
Upload
manuel-munoz-aguirre -
Category
Documents
-
view
217 -
download
0
Transcript of Governmental Regulation of Medical Devices
![Page 1: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/1.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 1/15
Governmental
regulation ofmedicaldevicesManuel Muñoz 20048
Mario Montoya 20405
Sonia Velázquez 23379
![Page 2: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/2.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 2/15
Critical elements for regulatoryattention
• Pre-market review• Post market surveillance• Representation of the product to the user
![Page 3: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/3.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 3/15
•
Pre-market: product complies with regulatoryrequirements• Advertising: correct product representation.• Post-market: continued safety and performance of
devices.
Stages of regulatory control
![Page 4: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/4.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 4/15
Framework for medical deviceregulation
![Page 5: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/5.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 5/15
Regulatory tools and general
requirements
![Page 6: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/6.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 6/15
Product control• All medical devices must satisfy safety and
performance, quality system and labelling
requirements.• Degree of scrutiny increases with device risk.
![Page 7: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/7.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 7/15
Vendor establishment control• Vendor information facilitates governments in
tracking medical device sales.• Examples:
• Australia: Enterprise ID Number • Canada: Permission• European Union: Registered address.• Japan: Hanbai-Gyoo / Hanbai Todoke• USA: FDA
• Post-market surveillance mandatory.
![Page 8: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/8.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 8/15
Post-market surveillance
• Continuous assessment of medical deviceperformance.
• Safety and performance problems occur through
actual use.
• Two most important activities:• Surveillance
• Adverse event reporting: structured datacollections.
• All device-related events that have resulted in seriousinjury or death must be reported.
![Page 9: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/9.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 9/15
Quality systems
• Is defined as the organizational structure,responsibilities, procedures, processes and resourcesneeded to implement quality management.
• International Organization for Standardization (ISO)• ISO13485:1996 includes requirements for medical
devices. (Includes 9001 + extra)• New ISO13485:200? is currently being developed.
• Includes: Manufacture, packaging, labelling,storage, installation, servicing, post-market handling.
![Page 10: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/10.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 10/15
• The key advantage regarding quality systems
is that they represent a preventive approachto assuring medical device quality.
![Page 11: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/11.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 11/15
GlobalHarmonzationTask Force
![Page 12: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/12.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 12/15
Objectives
• Need to harmonize national standards in orden tominimize regulatory barriers, facilitate trade andimprove access to new technologies.
• GHTF was founded in 1993 by the governments andindustries of Australia, Canada, Japan, EuropeanUnion, USA.
•
Encourage a convergence in standards andregulatory practices related to safety, performanceand quality of medical devices.
• Documents for regulatory practices.
![Page 13: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/13.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 13/15
Scope of 4 GHTF groups
![Page 14: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/14.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 14/15
GHTF Benefits
• Countries ensure their regulations are equivalentto other countries’.
• Safety performance issues are examined by
experts.
• GHTF creates international data bank for deviceinformation.
• International trade is enhanced.
• Provides an opportunity for countries to adoptcertain regulations.
![Page 15: Governmental Regulation of Medical Devices](https://reader036.fdocuments.in/reader036/viewer/2022062504/577ce75f1a28abf10394fdfa/html5/thumbnails/15.jpg)
7/31/2019 Governmental Regulation of Medical Devices
http://slidepdf.com/reader/full/governmental-regulation-of-medical-devices 15/15
Global Medical DeviceNomenclature
• Consistence in nomenclature is fundamental for
harmonization.
• CEN: Comité Européen de Normalisation produces anomenclature standard.• Give a common generic device description for
every general term.• Identify devices using the generic term.