1WorldSyncPresentation Title

1WorldSyncFDA UDI Compliance

Experience in Japan and Korea

April 11, 2017

Agenda

▪ About 1WorldSync

▪ FDA UDI Compliance

▪ Experience in Japan and Korea

▪ What’s Coming Next

– FDA GUDID

– UK NHS (Scan4Safety)

– EU EUDAMED

About 1WorldSync

3

Distribute &

Deliverthe product information

and digital content that

powers global commerce

Empower

Peoplewith trusted product information

for informed purchase decisions

& everyday well-being.

Bring Simplicity

& Efficiencyto global trading networks, through

technology, transparency, trust and

standardization.

Our Mission & Purpose

1WorldSync is the premier global network

for trusted product information, used by 20,000+ brands,

digital content providers and their trading communities

© 2016 1WorldSync Inc.

4

1WorldSync Focus

3Focus Audiences

5Core Verticals 11

Solutions for

• Retail

• Hardlines

• Consumer Goods

• Food Service

• Healthcare

Sources OR Recipients

• Supply Chain MDM

• Transparency &

Compliance

• Omni-Channel & Digital

Commerce© 2016 1WorldSync Inc.

5

1WorldSync Focus

1WorldSync is focusing on 5 core industries and 3 core audiences. Today’s focus is Healthcare and Compliance.

1WorldSync and GS1

6

™

1WorldSync

1WorldSync is owned by

Leading Med Device/IVD Manufacturers are using

1WorldSync for Product Information Distribution Strategies

7

FDA UDI Compliance

8

Objective of the UDI Program

9

FDA UDI Rules

▪ The label of every medical device (including all IVDs)

must have a UDI (Unique Device Identification).

▪ UDI = Device ID (DI) + Product ID (PI)

– Device Identifier (DI) (static) specific to device version or

model (GTIN is most commonly used)

– • Production Identifier(s) (PI) (dynamic) one or more

currently used control/production identifiers such as

lot/batch number, serial number, manufacturing date, or

expiration date

10

UDI on Label vs UDI Database (GUDID)

Submission

© 2016 1WorldSync Inc.

Labeling System

GUDID Submission Data

Medical Device Manufacturer

Prepare/Source Data

UDI Label

GUDID

Medical Device Manufacturers are required to label their products according to FDA rules and submit GUDID Data (device attributes) to FDA Global UDI Database (GUDID).

FDA UDI Compliance Dates

12

• Year 1: Class III and devices licensed under Public Health Services Act

• Year 2: Class II/I implants and life-supporting/sustaining

• Year 3: Class II items

• Year 5: Class I and items that have not been assigned a class

13

FDA UDI Requested Attributes (64 attributes)

▪ Primary Device Identifier (DI) (no control Information

▪ Secondary Device Identifier

▪ Unit of Use DI (If different from DI)

▪ Manufacturer’s Name, Address, Contact Information.

▪ GMDN

▪ Device Description

▪ Additional Product Description

▪ Trade Name/Brand Name (of DI and if part of a device

family)

▪ Model Number/Catalog Number (of DI and if part of a

model family)

▪ Clinical Size (volume, length, gauge, etc.)

▪ Storage Conditions

▪ Sterile?

▪ Sterilize prior to use, and method of sterilization

▪ Type of Control (PI) (serial number, Lot/Batch,

Expiration Date, and/or manufacturing date) (not actual

number or date)

▪ Can DI be reused?

▪ Contains Latex?

▪ Contains Human Tissue?

▪ FDA Numbers-

— Product Code

— Listing Number

— Premarket Authorization, 510K

— Supplement Number

▪ Direct Marking DI (if different from DI)

▪ Direct Marking Exemption Reason

▪ Marketing Status

▪ Is DI part of a Kit? Or a Combination Item?

▪ DI Discontinued Date (if applicable)

▪ Higher level information

▪ Parent DI, Child DI, Child Quantity

Some UDI UDI Statistics

▪ More than 1.3 Million DIs are registered submitted to

GUDID as of March 2017.

– Was less than 700K items as of April 2016 so the number

of items doubled in 1 year.

▪ More than 3500 companies have published records to

GUDID.

▪ More than 90% of DＩs are identified with GS1 GTIN.

© 2016 1WorldSync Inc.

GS1 and FDA UDI

▪ FDA recognizes 3 issuing agencies for UDI (DI):

– GS1(GTIN)

– HIBCC

– ICBBA

▪ GS1 GDSN standard attributes are extended and

validation rules adjusted to meet the need of FDA

GUDID attribute requirements.

© 2016 1WorldSync Inc.

“GDSN” = standard process to exchange

trusted product information.

▪ Based on GS1 standards – network of GS1 certified data pools.

▪ Used in Healthcare as in many other Industries

▪ Enabling immediate access from Trusts, Hubs, Distributors,

Regulatory bodies (FDA, EUDAMED, NHS) to high quality data

provided by the Brand Owners

Our Experience in Japan and Korea

17

UDI Seminars and Conferences

▪ Japan

– First UDI Seminar with GS1 Japan on Aug. 6, 2014

– 1WS UDI Conferences

▪ Oct. 7, 2015

▪ Apr. 13, 2016

▪ Jul. 21, 2016 (joint event with Globizz Inc.)

▪ 1WS will have a booth at MEDTEC Japan from April 19 to 21

http://www.medtecjapan.com/

▪ Other events planned in 2017 including workshops at US

Embassy in Tokyo, JETRO etc.

▪ Korea

– Invited to GS1 Korea’s UDI Seminar (Dec. 22, 2015) 18

Typical issues heard from device

manufacturers

▪ Many have no idea how to get items into GUDID except manually entering

data onto the GUDID GUI – they wanted a way to mass upload data onto

GUDID.

▪ Language barrier– understanding basic rules, applying for a GUDID

account, everything needs to be communicated in English via FDA helpdesk

▪ Many unfamiliar vocabularies – GMDN, DUNS, Sterilization Method, Single

Use, Direct Marking, Secondary DI, Convenience Kit…

▪ Several manufacturers are also requested by US GPOs to publish data via

GDSN.

▪ Lack of resources to do the job and internal employee trainings were

required and help needed preparing data to be submitted

▪ Some considered developing their own M2M connection with GUDID but it

was too costly to develop a one-off solution.

© 2016 1WorldSync Inc.

How to submit data to GUDID

© 2016 1WorldSync Inc.

Quick Comparison: Direct GUDID vs 1WS

21

DIRECT GUDID Submission Submission via 1WorldSync

Date entry methods Web UI

HL7 SPL (via ESG)

Web UI

Spreadsheet upload

XML

API

Data Loading and Maintenance (DLM)

service

Data published to FDA GUDID only Hospitals, GPOs, FDA GUDID, NHS and

other regulatory bodies

Language supported English Mandarin, Japanese, English, etc.

Test account Test account available for M2M

users only

Test account available (can prepare data in

advance)

Support location US US, Germany, UK, Japan, Taiwan

Support method FDA Helpdesk (Webform) Telephone, email

Training Online training (recorded video

only)

F2F training or webinar in English,

Mandarin, Japanese, and Korean.

How 1WS helped medical device

manufacturers

▪ FDA UDI rules

– Addressed general questions on UDI rules

– GUDID attribute requirements and mapping with GDSN including

product hierarchy rules

– Basic UDI trainings for internal employees (a.k.a “Special

Training”)

– Setting up UDI accounts

▪ Data submission and DLM (Data Loading and Maintenance) Service

– Most manufacturers used spreadsheet upload – 1WorldSync

staff helped validating data

– Many also applied for DLM for data quality assurance and

guaranteed data delivery to FDA

– Support for FDA certification test for M2M / SPL submission© 2016 1WorldSync Inc.

2016 Results – Class II compliance deadline

▪ 12 manufacturers from Japan and 2 manufacturers from Korea

successfully submitted Class II UDI data, all of them met the

deadline.

– More than 8,000 items loaded into GUDID via 1WS from Japan

and Korea

– 100% of those items use GS1 GTIN as DI

– They all used the GDSN-based solution but non-GDSN solution

is also available (i.e. items with non-GS1 DI)

▪ Several device manufacturers are publishing data not only to FDA

but also to GPOs.

© 2016 1WorldSync Inc.

What’s Coming Next

24

US FDA GUDID Compliance

▪ If you have Class III or Class II devices, you must be compliant NOW!

– There are manufacturers who are not compliant on time and

manufacturers introducing new items to the US market - Class II

devices are continued to be submitted.

▪ Compliance date for Class I products is Sept. 24, 2018.

– It is not announced yet when the GUDID account will be open for Class

I manufacturers.

– 1WorldSync can provide access to 1WS system and manufacturers can

start preparing data and validate against FDA rules from today!

25

NHS Scan4Safety

▪ NHS is National Health Service covering the UK

▪ There are 154 NHS Trusts in England providing

secondary case service. They group hospitals on a

geographical basis.

▪ Purpose of Scan4Safety is adoption of GS1 standards

and PEPPOL standards.

– Improving patient safety

– Efficiency and cost savings

▪ Scan4Safety demands suppliers to publish product data

to NHS via GS1 GDSN.

DH – Leading the nation’s health and

care

Supplier compliance timetable for NHS

© 2016 1WorldSync Inc. 27

Class Item Sync Compliance DatePrice Sync Compliance

Date

Class III

IVD List ASept. 30, 2017 Sept. 30, 2018

ClassⅡb

IVD List BSept. 30, 2018 Sept. 30, 2019

ClassⅡa

IVD self-testSept. 30, 2018 Sept. 30, 2019

ClassⅠIVD General

Sept. 30, 2019 Sept. 30, 2020

61 attributes required by NHS.

EU UDI Requirements Update

▪ EU Parliament adopted on April 5 the EU UDI regulation (also

known as the MDR, Medical Device Regulation).

▪ All medical device suppliers must submit their item data to

EUDAMED (European Database on Medical Devices) within 3 years

- by 2020 for MDs and 2022 for IVDs.

▪ 1WorldSync has launched the MDM Implementation Task Force with

selected healthcare customers.

– MD / IVD registration

– Validation

– Digital Assets

– Feedback of information provided by EUDAMED

© 2016 1WorldSync Inc. 28

EU UDI Regulation approved on 5th April 2017

Implementation plan over 3 years for MD’s

EU Commission Regulation

Q2 2017

EU Implementation Plan, Functional

Specifications

Audit

Testing Begins

Help Desk Creation

Production Go Live

Q2 2020

3 Years

EUDAMED Items to note

▪ EUDAMED attributes identified as of today are about 30.

▪ All class of medical devices go live at the same time

– IVD’s go live in 2022

▪ GS1, HIBCC, & ICCBA will be acceptable Identifiers

▪ GMDN will not be mandatory

– EU will research for a nomenclature

▪ Must be Free and available to all

▪ Member states are not allowed to adjust

▪ All levels of hierarchy, except shipping containers

The impact on your organization

31

Prepare your strategy - Ask yourself…

▪ How many products do you have?

▪ How do you manage your product content

_ Governance - people & definitions?

_ Where is the information today?

_ Attributes ?

_ How do you communicate today with your trading

partners?

▪ How do you want to leverage the FDA / NHS / EUDAMED

mandates to share product content in the global market?

32

We can help you to :

▪ START NOW!

▪ Take control…before you lose control.

▪ Organize your processes

▪ Create a single source of product information truth

▪ Implement a single data distribution strategy for global

commercial and regulatory compliance

▪ Developing or establishing a formal data governance

strategy

33

© 2017 1W or ldSync

Thank you

34