An update on the bar code guideline for medical devices in Japan Tomohiro INOUE Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare 1st October, 2013

• Secure & improve people’s life

Public Health

Work environment

Social-Security

• Develop economy

• Cope with changes

Social Welfare

Aging with fewer children

Profession

Social security policy

Gender equality Economic structure

Labor policy 2

(Approx. 32k personnel: Dec. 2012)

3

• Window as administration function • Plan promotion • Take various measures • Consultation on insurance reimbursement price • Instruct on distribution improvement

4

Administration

More stakeholders

MHLW

Healthcare Service Providers

Implement administrative measures

Health Policy Bureau Economic Affairs Div.

Pharmaceutical and Food Safety Bureau - Safety Div.

Propel Medical Safety

Review, Approve & conduct Post Market Survey on safeness & effectiveness of Medical Devices effectively, safely & promptly.

Academies Citizens

PMDA Many mores…

Scientific judgment

Industry Associations JFMDA

GS1 Japan

Prompt delivery of up-to-date medical technologies to the market Secure further safeness of Medical Devices Strengthen International competence

Medical Device Manufacturers & Suppliers PMDA : Pharmaceuticals and Medical Devices Agency JFMDA : The Japan Federation of Medical Devices Associations

5

26 Dec. 2001

2002 – (Every year) 31 Mar. 2003

22 Jun. 2007 28 Mar. 2008

Ground design aiming at information revolution in Health Science field Statistics survey on Medical Device informatization progress Medical devices industrial vision 19 Sep. 2008 New medical devices and a medical technology industrial vision 26 Jun. 2013 Medical devices industrial vision Three-year deregulation program Guidelines for Placing Standard Codes (Barcode Marking) on Medical Devices

6

Guidelines for Placing Standard Codes (Barcode Marking) on

7

1980s ∥ 1999

Guideline Manual (JFMDA)

2000 2001

Database for All Healthcare Products (MEDIS-DC)

2002

Revised Pharmaceutical Affairs Law effectuated

| | 2005 2006 2007 2008 2009

Logistics & Usage report became mandatory. Manufacturers & Wholesalers implemented GS1-128 traceability.

Revised Guideline Manual (JFMDA) Followed by Dental Trade Association

Direct Marking Guideline

Guideline (MHLW) (Issued in March 2008)

2010 2011

Implementation required (time limit)

2012

(Step-by-step by March 2009 / March 2010 / March 2011) 8

•

Objective Promote Efficient supply chain

•

Efficient medical office works

Secure

Prevent

Traceability

Medical error

Implementation •

Applied to –

•

Contents –

•

GS1-128 recommended

Database –

•

GTIN recommended

Symbol –

•

Product code, Expiry Date & Lot or Serial #

Product Codes –

•

Medical Devices, in Vitro Diagnostics & Consumable Supplies

Open source DB opened to public

Implement by –

1 to 3 years after the issuance of the guideline http://www.gs1jp.org/pdf/006.pdf

9

• Not a legal regulation • An administrative notification (no legal penalty)

• Following JFMDA Guideline Manual • First edition issued in 1999

• Package level marking on the Medical Device packages • Direct Part Marking (DPM) is not yet required

• Harmonized with GS1 standards • Promote registration to the Data Base opened to public • Making manufacturers aware of the Data Base for registration

10

MHLW:

< Primary Packaging >

GS1-128

< Inside Box >

< Outside box >

< Secondary Packaging >

< Shipping Container >

GS1-128

GS1-128

2D Barcode standardized by ISO

AI (01) GTIN (Partly required) (Partly required)

AI (17) Expiry Date AI (10) Lot No. or AI (21) Serial No.

11

Company OT Company OT Company OT

AI (01) GTIN

AI (17) Expiration Date

AI (10) Batch/Lot No. 12

AI (01) GTIN

AI (17) Expiration Date

AI (10) Batch/Lot No. 13

AI (01) GTIN

AI (17) Expiration Date

AI (10) Batch/Lot No. 14

[Annual Survey by MHLW in Sep. 2012] < Primary Packaging >

< Secondary Packaging >

GTIN-13 (JAN) Acquired

Individual Package Labeled

Inside Box Labeled

Registered to MEDIS-DC Database

Medical Devices

99.1%

81.1%

97.6%

80.0%

In Vitro Diagnostics

100.0%

92.5%

99.7%

65.7%

Consumable Supply

96.8%

-

88.4%

65.0%

≈ GS1:

Companies answered: 581/756 = 84.4% 15

120.0%

100.0%

80.0%

Medical Supplies Medical Devices Sub-Total (Supplies+MD) Total In Vitro Diagnostics

60.0%

40.0%

Guideline announced in MAR

20.0%

0.0% 2005

2006

2007

2008

2009

2010

2011

2012

16

Registered Items (Total): (674 Companies) (as of 16 Aug. 2013)

Medical Equipment: 17,904 Medical Apparatus: 740,419

In vitro Diagnostics: 11,961

Miscellaneous: 72,922 17

GTIN-13 Acquired Rate (September, 2012): Medical Device - 99.1%

MHLW

FPMAJ

JFMDA

Medical Device: 843,206 items (674 Companies) (as of 16 Aug. 2013)

[2] Allocate Company Prefix

Database Registration:

[1] Apply for GS1 Company Prefix

[4] Inquire-Search-Download

[3] Register Product Data

Manufacturer or Supplier

GS1 Japan [4] Inquire-Search-Download

Distributors

Hospitals

FPMAJ :The Federation of Pharmaceutical Manufacturers' Associations of Japan

18

• UDI Patio • Talking how the BarCode labeling in Japan should be – Discussion on issues about UDI

• Members Administration

Industries

• DPM on Medical Devices • Current • Future

: Not required in the Guideline : Study when to enact DPM provision watching followings, » International trends » Technology development and its validation

• Expansion of the scope of marking data • Current • Future

: Some data are left to the discretion of companies. : Shall be considered in the future by studying how such data are actually displayed and used. 19

Contact Details

Tomohiro INOUE Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo, JAPAN 100-8916

T +81-3-3595-2421 E [email protected]