TOK-161320002-20070307
Seminar about the field of Japan - Brazil medical care regulation
September/10/2015
Yasutaka WatanabeReview DirectorOffice of Medical Devices ⅢPharmaceuticals and Medical Devices Agency (PMDA)
・PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people who have suffered from adverse drug reactions.
• We conduct our mission in accordance with the following principles:Wepursue the development of medical science while performing our duty with greater transparency based on our mission to protect public health and the lives of our citizens.
• We will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices.
• We make science-based judgments on quality, safety, and efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise.
• We play an active role within the international community by promoting international harmonization.
• We conduct services in a way that is trusted by the public based on our experiences from the past.
Our Philosophy
Organizational chart
2015/3/31PMDA ALL 753
Review Division 492
Safety Division 152
Relief Division 33
TOK-161320002-20070307
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•About PMDA•Outline of Reviews and Related Services•Application Categories for Medical Devices•Review Teams for MDs/IVDs•Device Classes and Regulation•The application and the application division•Examination policy•Consultation menu•Review Reports•The examination results for the past 5 years•Future examination target
TOK-161320002-20070307
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Outline of Reviews and Related Services
Application Categories for Medical Devices
①Brand-new Medical Device (Shin)clearly distinct from approved/certified devices in its structure, intended
use, indications, direction of usage and performance.should be subjects of reexamination process
②Improved Medical Device (Kairyo)・NOT substantially equivalent to approved/certified devices in its structure, intended use, indications and performance.
no specific novelty to submit for reexamination③Generic Medical Device (Me-too Device, Kouhatsu)
substantially equivalent to approved/certified devices in its structure, intended use, indications and performance.
Team1 Team2 Team3 Team4 Team5 Team6 Team8OMD Ⅰ ①&② ①&② ①&②
OMD Ⅱ ①&② ①&② ①&② ①&②
OMD Ⅲ ③ ③ ③ ③ ③ ③ ③
Team 7 In vitro diagnostic medical devices
Review Teams for MDs/IVDs
OMD I & II:New/Improved Device Teams 1-8
OMD III:Me-too Device
Teams 1-8
Team 1 Field of ophthalmology, otorhinolaryngology
Team 2 Field of dentistry
Team 3 Field of neurosurgery, cardiology, vascular surgery, respiratory
Team 4 Field of neurosurgery, cardiology, vascular surgery, respiratory (electronic devices)
Team 5 Field of gastroenterology, urology, gynecology
Team 6 Field of orthopedics, plastic surgery, dermatology
Team 7 In vitro diagnostic medical devices
Team 8 Others
Team1 Team2 Team3 Team4 Team5 Team6 Team8
Even in a failure mode, the risk may be
considered not high.• electronic endoscopy
• MRI instruments• gastrointestinal catheter
• US echo• dental alloys
Devices of high invasiveness:
in a failure mode life-
threatening hazards may be expected.• pacemaker
• artificial heart valve
• cardiac stent
In a failure mode, high risk is expected.
• dialyzer, artificial bone
• ventilator• IABP-catheter
Even in a failure mode, the risk may
be considered extremely low.
• in vitro diagnostic device • surgical knife
• X-ray film• dental instruments
Device Classes and RegulationRisk HighLow
Only Notification to PMDA needed
Conformity Assessment by 3rd Party Bodies
MHLW Approval:PMDA review
Examples
Regula-tion
General MDs Controlled MDs Specially Controlled MDsCate-gory
GHTF ClassⅠ ClassⅡ ClassⅢ ClassⅣ
PMD-Act Revision
Class Ⅰ Class Ⅱ Class Ⅲ Class Ⅳ①Brand-new Medical Device (Shin)
MHLW Approval:PMDA review
MHLW Approval:PMDA review
MHLW Approval:PMDA review
MHLW Approval:PMDA review
②ImprovedMedical Device(Kairyo)
MHLW Approval:PMDA review
MHLW Approval:PMDA review
MHLW Approval:PMDA review
MHLW Approval:PMDA review
③Generic Medical Device (Me-too Device, Kouhatsu)
Only Notification to PMDA needed
Conformity Assessment by 3rd Party Bodies/PMD-Act Revision
Conformity Assessment by 3rd Party Bodies/PMD-Act Revision/MHLW Approval:PMDA review
MHLW Approval:PMDA review
The application and the application division
What is Approval Review?
- Approve devices which does not meet the refusal conditions
PMD-Act Article23-2-5 paragraph (2), item (iii), (a)&(b) (a)The given device is judged that it does not have its own efficacy, effectiveness and/or performance as to be concerned in the application.(b)The given device is judged of no value for medical use because its adverse effect(s) far exceed its efficacy, effectiveness and/or performance.
Basic policy of approval reviewAffirm that applied device has efficacy for its intended use and does not have remarkably adverse effect regarding its efficacy.
Risk < Benefit Approval
Application & STED
STED
1. Outline of the device
2. Basic requirements, and compatibility with the basic requirements
3. Information on the device
4. Summaries of design verification and documents confirming validity
5. Labeling
6. Risk analysis
7. Information on manufacturing
Application
Classification
NameGeneric name
Brand name
Use purpose or effect
Shape, structure and principle
Raw material
The performance and the standard about the safety
Use method
Safekeeping method and validity
Production technique
Note
Consultation menu
Consultation menu
Pre-deveropment consultation
Clinical test advisability consultation
Protocol consultation
Safety test
Quality test
Performance test
Feasibility clinical trial test
Clinical trial test
Evaluation consultation
Safety
Quality
Performance
Feasibility clinical trial
Clinical trial
Document sufficiency・Application division consultation
Consultation about GCP/GLP/GPSP
Reliability standard conformability investigation consultation
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Review Reports: Medical DevicesTOK-161320002-20070307
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The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.The review reports were selected for translation among those of new medical devices that recently received marketing approval, in consideration of relevant factors including the novelty and priority.Read more:Procedures for Public Release of Information on Review of Applications for New Medical Devices (PMDA Notification No. 0206007, February 6, 2009)
Review ReportsTOK-161320002-20070307
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http://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html
Brand Name Generic Name Approved In
PDFEN
PDFJP
Adacolumn leukocytapheresis device June.2012 PDF PDF
DuraHeart Left Ventricular Assist System
implantable ventricular assist device Dec.2010 PDF PDF
Endeavor Coronary Stent System coronary stent Mar. 2009 PDF PDF
Fetal Shunt shunt for fetal pleural effusion Nov. 2011 PDF PDF
GORE TAG Thoracic Aortic Stent Graft System aortic stent grafts Mar. 2008 PDF PDF
Implantable Ventricular Assist System EVAHEART
implantable ventricular assist device Dec.2010 PDF PDF
JACEother surgical/orthopedic materials (autologous cultured epidermis)
Oct. 2007 PDF PDF
Review time (Shin)
Shin(Priority) 2010 2011 2012 2013 2014
Tile level 50% 50% 50% 50% 60%
TargetTotal examination period
16Month
15Month
13Month
10Month
10Month
Results
Total examination period
15.1Month
4.3Month
9.3Month
9.0Month
8.8Month
approval number 3 6 5 14 5
Shin(Usually) 2010 2011 2012 2013 2014
Tile level 50% 50% 50% 50% 60%
TargetTotal examination period
21Month
20Month
17Month
14Month
14Month
Results
Total examination period
16.5Month
9.7Month
12.7Month
6.3Month
5.6Month
approval number 15 27 41 80 62
Review time (Kairyo)
Kairyo(Clinical) 2010 2011 2012 2013 2014
Tile level 50% 50% 50% 50% 52%
TargetTotal examination period
16Month
14Month
12Month
10Month
10Month
Results
Total examination period
15.5Month
13.9Month
17.3Month
11.6Month
9.9Month
approval number 40 55 44 63 35
Kairyo(Non Clinical) 2010 2011 2012 2013 2014
Tile level 50% 50% 50% 50% 52%
TargetTotal examination period
11Month
10Month
9Month
6Month
6Month
Results
Total examination period
14.5Month
13.3Month
9.7Month
7.5Month
6.0Month
approval number 182 218 229 231 213
Review time(Kouhatu)
Kouhatu 2010 2011 2012 2013 2014
Tile level 50% 50% 50% 50% 52%
TargetTotal examination period
6Month
5Month
4Month
4Month
4Month
Results
Total examination period
11.0Month
5.0Month
4.0Month
3.9Month
3.9Month
approval number 1,391 907 1,216 958 920
Future examination target
Month 2014 2015 2016 2017 2018
Shin
Priority 10 60 60 70 70 80
Usually 14 60 60 70 70 80
Kairyo
Clinical 10 52 54 56 58 60
NonClinical
6 52 54 56 58 60
Kouhatu 4 52 54 56 58 60
Thank you for your Attention
http://www.pmda.go.jp/english/index.html
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