An update on the bar code guideline for medical devices in Japan

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: <Individual
≈ GS1:
Package>
< 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 inoue-tomohiro@mhlw.go.jp