Sun am HR 6 AL-AWADHI - World Health Organization Kuwait Institute for Medical Specialization Kuwait...
17
Safe Care: Safe Care: Safe Care: Safe Care: An Initiative for Regulations in Kuwait An Initiative for Regulations in Kuwait An Initiative for Regulations in Kuwait An Initiative for Regulations in Kuwait Hanan A. Al Hanan A. Al Hanan A. Al Hanan A. Al Awadhi Awadhi Awadhi Awadhi WHO Global Forum on Medical Devices 2013 WHO Global Forum on Medical Devices 2013 WHO Global Forum on Medical Devices 2013 WHO Global Forum on Medical Devices 2013 November 2013 November 2013 November 2013 November 2013 1
Transcript of Sun am HR 6 AL-AWADHI - World Health Organization Kuwait Institute for Medical Specialization Kuwait...
Safe Care: Safe Care: Safe Care: Safe Care: An Initiative for Regulations in KuwaitAn Initiative for Regulations in KuwaitAn Initiative for Regulations in KuwaitAn Initiative for Regulations in Kuwait
Hanan A. AlHanan A. AlHanan A. AlHanan A. Al����AwadhiAwadhiAwadhiAwadhi
WHO Global Forum on Medical Devices 2013WHO Global Forum on Medical Devices 2013WHO Global Forum on Medical Devices 2013WHO Global Forum on Medical Devices 2013
November 2013November 2013November 2013November 2013
1
where we come from…where we come from…where we come from…where we come from…
2
o Started as a committee under Started as a committee under Started as a committee under Started as a committee under the umbrella of Kuwait the umbrella of Kuwait the umbrella of Kuwait the umbrella of Kuwait Society of Engineers in 2006Society of Engineers in 2006Society of Engineers in 2006Society of Engineers in 2006
o In 2008, it was upgraded to a In 2008, it was upgraded to a In 2008, it was upgraded to a In 2008, it was upgraded to a full professional group within full professional group within full professional group within full professional group within KSEKSEKSEKSE
o First nonFirst nonFirst nonFirst non����medical medical medical medical organization in Kuwait that organization in Kuwait that organization in Kuwait that organization in Kuwait that offers accredited trainings by offers accredited trainings by offers accredited trainings by offers accredited trainings by the Kuwait Institute for the Kuwait Institute for the Kuwait Institute for the Kuwait Institute for Medical SpecializationMedical SpecializationMedical SpecializationMedical Specialization
Kuwait Association for Biomedical Kuwait Association for Biomedical Kuwait Association for Biomedical Kuwait Association for Biomedical EngineersEngineersEngineersEngineers
o Founded by KABME members Founded by KABME members Founded by KABME members Founded by KABME members in in in in 2010 2010 2010 2010 under the umbrella of under the umbrella of under the umbrella of under the umbrella of IEEE Kuwait SectionIEEE Kuwait SectionIEEE Kuwait SectionIEEE Kuwait Section
o Joint activities with KABMEJoint activities with KABMEJoint activities with KABMEJoint activities with KABME
o Welcomes nonWelcomes nonWelcomes nonWelcomes non����engineering engineering engineering engineering professionals as affiliate and professionals as affiliate and professionals as affiliate and professionals as affiliate and associate membersassociate membersassociate membersassociate members
3
IEEE Engineering in Medicine and IEEE Engineering in Medicine and IEEE Engineering in Medicine and IEEE Engineering in Medicine and Biology SocietyBiology SocietyBiology SocietyBiology Society���� KUWAIT ChapterKUWAIT ChapterKUWAIT ChapterKUWAIT Chapter
OutlineOutlineOutlineOutline
o Medical Device Regulations in KuwaitMedical Device Regulations in KuwaitMedical Device Regulations in KuwaitMedical Device Regulations in Kuwait
o Safe Care InitiativeSafe Care InitiativeSafe Care InitiativeSafe Care Initiative
4
Overview of Regulations Overview of Regulations Overview of Regulations Overview of Regulations in Kuwaitin Kuwaitin Kuwaitin Kuwait
5
Food, drugs & medicines (pharmaceutical & herbal) are Food, drugs & medicines (pharmaceutical & herbal) are Food, drugs & medicines (pharmaceutical & herbal) are Food, drugs & medicines (pharmaceutical & herbal) are
regulated by the MOH Food & Drug Control regulated by the MOH Food & Drug Control regulated by the MOH Food & Drug Control regulated by the MOH Food & Drug Control
Department Department Department Department
Radioactive materials & equipment used in diagnostic Radioactive materials & equipment used in diagnostic Radioactive materials & equipment used in diagnostic Radioactive materials & equipment used in diagnostic
radiology, nuclear medicine and radiation therapy are radiology, nuclear medicine and radiation therapy are radiology, nuclear medicine and radiation therapy are radiology, nuclear medicine and radiation therapy are
regulated by the MOH Radiation Protection Departmentregulated by the MOH Radiation Protection Departmentregulated by the MOH Radiation Protection Departmentregulated by the MOH Radiation Protection Department
Medical devices are registered as products Medical devices are registered as products Medical devices are registered as products Medical devices are registered as products ONLYONLYONLYONLYwithin within within within
the Nonthe Nonthe Nonthe Non����classified Products Unit of the MOH Food & classified Products Unit of the MOH Food & classified Products Unit of the MOH Food & classified Products Unit of the MOH Food &
Drug Control Department Drug Control Department Drug Control Department Drug Control Department
Medical Devices in Kuwait: Key Points Medical Devices in Kuwait: Key Points Medical Devices in Kuwait: Key Points Medical Devices in Kuwait: Key Points
6
� There There There There are no classification requirements or special are no classification requirements or special are no classification requirements or special are no classification requirements or special restriction for importing medical devices (e.g. restriction for importing medical devices (e.g. restriction for importing medical devices (e.g. restriction for importing medical devices (e.g. manufacturing site registration)manufacturing site registration)manufacturing site registration)manufacturing site registration)
� It It It It is strictly forbidden to import preis strictly forbidden to import preis strictly forbidden to import preis strictly forbidden to import pre����owned medical owned medical owned medical owned medical devices in devices in devices in devices in KuwaitKuwaitKuwaitKuwait
� Medical devices are mostly are Medical devices are mostly are Medical devices are mostly are Medical devices are mostly are imported from the US & imported from the US & imported from the US & imported from the US & the the the the EUEUEUEU
In an absence of regulations…In an absence of regulations…In an absence of regulations…In an absence of regulations…
7
Safe Care Initiative Safe Care Initiative Safe Care Initiative Safe Care Initiative
8
� Started in Started in Started in Started in 2012 2012 2012 2012 to promote the use of safe technology to promote the use of safe technology to promote the use of safe technology to promote the use of safe technology in healthcare in Kuwaitin healthcare in Kuwaitin healthcare in Kuwaitin healthcare in Kuwait
� Aiming to establish an independent body to regulate Aiming to establish an independent body to regulate Aiming to establish an independent body to regulate Aiming to establish an independent body to regulate medical devices in Kuwait medical devices in Kuwait medical devices in Kuwait medical devices in Kuwait
� Targeting public, healthcare community & state Targeting public, healthcare community & state Targeting public, healthcare community & state Targeting public, healthcare community & state officials (Ministers & MPs)officials (Ministers & MPs)officials (Ministers & MPs)officials (Ministers & MPs)
Kuwait Forum for Healthcare Technology Regulations Kuwait Forum for Healthcare Technology Regulations Kuwait Forum for Healthcare Technology Regulations Kuwait Forum for Healthcare Technology Regulations in collaboration with the Saudi Food & Drug Authority, May in collaboration with the Saudi Food & Drug Authority, May in collaboration with the Saudi Food & Drug Authority, May in collaboration with the Saudi Food & Drug Authority, May 2012 2012 2012 2012
9
10
Outreach Outreach Outreach Outreach 1111���� Social MediaSocial MediaSocial MediaSocial Media
@Q@Q@Q@Q8888BMEBMEBMEBME
Facebook Facebook Facebook Facebook
11
Outreach Outreach Outreach Outreach 2222���� MediaMediaMediaMedia
Local TV Local TV Local TV Local TV Channel: KTV1Channel: KTV1Channel: KTV1Channel: KTV1
Local Radio: Local Radio: Local Radio: Local Radio: FM FM FM FM 97.597.597.597.5
Outreach Outreach Outreach Outreach 3333���� SocialsSocialsSocialsSocials
Outreach Outreach Outreach Outreach 4444���� Conferences & Technical TrainingsConferences & Technical TrainingsConferences & Technical TrainingsConferences & Technical Trainings
12
Updates on Medical Imaging Informatics Updates on Medical Imaging Informatics Updates on Medical Imaging Informatics Updates on Medical Imaging Informatics Workshop Workshop Workshop Workshop 2012201220122012
Kuwait MEDICA Kuwait MEDICA Kuwait MEDICA Kuwait MEDICA 2013201320132013
Arab Regulatory Conference Arab Regulatory Conference Arab Regulatory Conference Arab Regulatory Conference 2013201320132013����EgyptEgyptEgyptEgypt
Arab Health Arab Health Arab Health Arab Health 2013201320132013���� UAEUAEUAEUAE
13
Outreach Outreach Outreach Outreach 5555���� ExposExposExposExpos
Lessons Learned…Lessons Learned…Lessons Learned…Lessons Learned…
14
� Effective change is a collaborative change Effective change is a collaborative change Effective change is a collaborative change Effective change is a collaborative change
� Change can be started sociallyChange can be started sociallyChange can be started sociallyChange can be started socially
� We grow by networking!We grow by networking!We grow by networking!We grow by networking!
15
The GCC The GCC The GCC The GCC
Food & Drug Food & Drug Food & Drug Food & Drug
AuthorityAuthorityAuthorityAuthority
Kuwait Kuwait Kuwait Kuwait
Authority for Authority for Authority for Authority for
Healthcare Healthcare Healthcare Healthcare
TechnologyTechnologyTechnologyTechnology
Safe Care Safe Care Safe Care Safe Care
InitiativeInitiativeInitiativeInitiative
Because a call for medical devices Because a call for medical devices Because a call for medical devices Because a call for medical devices regulations is in reality a call for public regulations is in reality a call for public regulations is in reality a call for public regulations is in reality a call for public health. And, public health knows no health. And, public health knows no health. And, public health knows no health. And, public health knows no
boundaries! We aim big:boundaries! We aim big:boundaries! We aim big:boundaries! We aim big: The GCC FDA! The GCC FDA! The GCC FDA! The GCC FDA!
Thank Thank Thank Thank YouYouYouYou
feel free to reach usfeel free to reach usfeel free to reach usfeel free to reach us @ @ @ @
16
[email protected]@[email protected]@kse.org.kw ; ; ; ; [email protected]@[email protected]@ieee.org
www.blog.kabme.orgwww.blog.kabme.orgwww.blog.kabme.orgwww.blog.kabme.org
www.facebook.com/groups/kabmewww.facebook.com/groups/kabmewww.facebook.com/groups/kabmewww.facebook.com/groups/kabmeww.facebook.com/groups/ww.facebook.com/groups/ww.facebook.com/groups/ww.facebook.com/groups/embs.kuwaitembs.kuwaitembs.kuwaitembs.kuwait
@ Q@ Q@ Q@ Q8888BME BME BME BME
Join us @Join us @Join us @Join us @
The First Ministry of Defense Symposium The First Ministry of Defense Symposium The First Ministry of Defense Symposium The First Ministry of Defense Symposium on Biomedical Engineering on Biomedical Engineering on Biomedical Engineering on Biomedical Engineering
December December December December 11111111����12121212, , , , 2013201320132013
JaberJaberJaberJaber AlAlAlAl����Ahmad Armed Forces HospitalAhmad Armed Forces HospitalAhmad Armed Forces HospitalAhmad Armed Forces Hospital���� KUWAITKUWAITKUWAITKUWAIT
www.blog.kabme.orgwww.blog.kabme.orgwww.blog.kabme.orgwww.blog.kabme.org
17
