1WorldSync. 1WorldSync FDA UDI Compliance. April 11, 2017

Transcription

1 1WorldSync 1WorldSync FDA UDI Compliance Experience Presentation in Japan and TitleKorea April 11, 2017

2 Agenda About 1WorldSync FDA UDI Compliance Experience in Japan and Korea What s Coming Next FDA GUDID UK NHS (Scan4Safety) EU EUDAMED

3 About 1WorldSync 3

4 4 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 Bring Simplicity & Efficiency to global trading networks, through technology, transparency, trust and standardization. Distribute & Deliver the product information and digital content that powers global commerce Empower People with trusted product information for informed purchase decisions & everyday well-being WorldSync Inc.

5 5 1WorldSync Focus 1WorldSync Focus 1WorldSync is focusing on 5 core industries and 3 core audiences. Today s focus is Healthcare and Compliance. 5 Core Verticals 11 Solutions for Sources OR Recipients Retail Hardlines Consumer Goods Food Service Healthcare 3 Focus Audiences Supply Chain MDM Transparency & Compliance Omni-Channel & Digital Commerce WorldSync Inc.

6 1WorldSync and GS1 1WorldSync is owned by 1WorldSync 6

7 Leading Med Device/IVD Manufacturers are using 1WorldSync for Product Information Distribution Strategies 7

8 FDA UDI Compliance 8

9 Objective of the UDI Program 9

10 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

11 UDI on Label vs UDI Database (GUDID) Submission 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). Prepare/ Source Data Medical Device Manufacturer Labeling System GUDID Submission Data UDI Label GUDID WorldSync Inc.

12 FDA UDI Compliance Dates 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 12

13 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

14 Some UDI UDI Statistics More than 1.3 Million DIs are registered submitted to GUDID as of March 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 WorldSync Inc.

15 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 WorldSync Inc.

16 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

17 Our Experience in Japan and Korea 17

18 UDI Seminars and Conferences Japan First UDI Seminar with GS1 Japan on Aug. 6, WS UDI Conferences Korea 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 Other events planned in 2017 including workshops at US Embassy in Tokyo, JETRO etc. Invited to GS1 Korea s UDI Seminar (Dec. 22, 2015) 18

19 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 WorldSync Inc.

20 How to submit data to GUDID WorldSync Inc.

21 Quick Comparison: Direct GUDID vs 1WS 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, Training Online training (recorded video only) 21 F2F training or webinar in English, Mandarin, Japanese, and Korean.

22 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 WorldSync Inc. Support for FDA certification test for M2M / SPL submission

23 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 WorldSync Inc.

24 What s Coming Next 24

25 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, 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

26 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

27 Supplier compliance timetable for NHS 61 attributes required by NHS. Class Item Sync Compliance Date Price Sync Compliance Date Class III IVD List A ClassⅡb IVD List B ClassⅡa IVD self-test ClassⅠ IVD General Sept. 30, 2017 Sept. 30, 2018 Sept. 30, 2018 Sept. 30, 2019 Sept. 30, 2018 Sept. 30, 2019 Sept. 30, 2019 Sept. 30, WorldSync Inc. 27

28 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 WorldSync Inc. 28

29 EU UDI Regulation approved on 5 th April 2017 Implementation plan over 3 years for MD s EU Commission Regulation Q Audit Testing Begins Help Desk Creation EU Implementation Plan, Functional Specifications Production Go Live Q Years

30 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

31 The impact on your organization 31

32 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

33 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

34 Thank you W orldsync 34