seminar about the field of japan - brazil medical …team1 team2 team3 team4 team5 team6 team8 omd...

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

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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

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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)





②ImprovedMedical Device(Kairyo)





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


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％


21Month

20Month

17Month

14Month

14Month

Results


16.5Month

9.7Month

12.7Month

6.3Month

5.6Month


Review time （Kairyo）

Ｋａｉｒｙｏ（Ｃｌｉｎｉｃａｌ） 2010 2011 2012 2013 2014

Tile level 50％ 50％ 50％ 50％ 52％


16Month

14Month

12Month

10Month

10Month

Results


15.5Month

13.9Month

17.3Month

11.6Month

9.9Month


Ｋａｉｒｙｏ（ＮｏｎＣｌｉｎｉｃａｌ） 2010 2011 2012 2013 2014

Tile level 50％ 50％ 50％ 50％ 52％


11Month

10Month

9Month

6Month

6Month

Results


14.5Month

13.3Month

9.7Month

7.5Month

6.0Month


Review time（Kouhatu）

Ｋｏｕｈａｔｕ 2010 2011 2012 2013 2014

Tile level 50％ 50％ 50％ 50％ 52％


6Month

5Month

4Month

4Month

4Month

Results


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

seminar about the field of japan - brazil medical …team1 team2 team3 team4 team5 team6 team8 omd...

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