Unique Device Identification A Global View

Transcription

1 UDI Unique Device Identification A Global View November 11, 2015 JACKIE RAE ELKIN, MEDTRONIC GLOBAL REGULATORY AFFAIRS

2 INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) UDI WORK GROUP UDI WG Established under Global Harmonization Task Force (GHTF) October, IMDRF Guidance UDI for Medical Devices Final Version, December 9, A Global View of UDI October 29, 2015 Confidential

3 UDI The Whole World is Watching 3 A Global View of UDI October 29, 2015 Confidential

4 Country Timeline Standard Label Requirements Data Reporting Japan 1999 GS1 Device Identifier, Production Identifiers to Unit of Use Level Spain 2006 GS1 Device Identifier, Production Identifiers to Unit of Use Level Turkey 2009 GS1 & HIBCC Device Identifier, Production Identifiers to Unit of Use Level India 2012 GS1 Device Identifier, Production Identifiers to Unit of Use Level IMDRF Release 2013 GS1 & HIBCC Device Identifier, Production Identifiers to Unit of Use Level USA Class III: 2014 Implants, LS/LS: 2015 Class II: 2016 Class I: 2018 GS1 & HIBCC ICCBBA Device Identifier, Production Identifiers Argentina GS1 Device Identifier, Production Identifiers and Global Location Numbers (GLN). Track and Trace Implementation. MEDIS: Reimbursement Ministry of Health, Labor and Welfare Reimbursement SAS - Department of Health Andaluz TITUBB: Reimbursement SGK Social Security Institute Procurement Ministry of Health & Family Welfare UDI - International Medical Device Regulators Forum (IMDRF) UDI Database: Regulatory US Food and Drug Administration Database Traceability ANMAT 4 A Global View of UDI October 29, 2015 Confidential

5 US FDA UDI IMPLEMENTATION 1) Development of a standardized system of unique device identifiers (UDI) Final Rule Class III Devices UDI Compliance Timelines LABEL to Bear UDI Compliance 2014 Direct Marking Compliance 2016 Inventory Depletion ) Placing UDI in human readable and AutoID formats on labeling, device or both 3) Register UDI data in FDA public database GUDID (+60 data elements) Implants, Life Supporting / Life Sustaining Devices Non-sterile Implants in FDA Exception Letter of 11/19/2014 Class II Class I, Exempt, Not Classified Label Date Format on for Devices Not Subject UDI (Implants Exempt) N/A A Global View of UDI October 29, 2015 Confidential

6 ARGENTINA TRACEABILITY PROJECT ANMAT Regulation on Traceability requires tracking and reporting from manufacture through the supply chain, into the hospital and to the patient. GS1 Global Location Number (GLN) is used for tracking movement locations. The Track and Trace implementation requires Serialization of all products listed in the implementation. Deadlines: February 2015 defibrillators/cardioverters, electric stimulators for cochlear hearing, intraocular lenses, cardiac pacemaker, breast internal prosthesis; August 2015 vascular coronary endoprosthesis (stent), hip prosthesis, and column prosthesis. 6 A Global View of UDI October 29, 2015 Confidential

7 Country Timeline Standard Label Requirements Data Reporting System EU 2015/2016 GS1, HIBCC, ICCBBA Canada 2016 GS1, HIBCC, ICCBBA Device Identifier, Production Identifier to Unit of Use Level Follow IMDRF Turkey 2017 GS1, HIBCC Device Identifier, Production Identifier to Unit of Use. Track and Trace Serialization? Japan TBD GS1 Device Identifier, Production Identifier MEDIS Eudamed Database: European Commission UTS: Track all processes of import products from Customs to customer China 2016? International (GS1) and National? Brazil Draft 12/2015? GS1, HIBCC, ICCBBA Device Identifier, Production Identifier to Unit of Use Level Follow IMDRF S. Korea TBD TBD TBD CFDA Database Singapore TBD TBD TBD Saudi Arabia 2018 GS1, HIBBC, ICCBBA Taiwan GS1, HIBBC, ICCBBA 7 A Global View of UDI October 29, 2015 Confidential Device Identifier, Production Identifier to Unit of Use Level Device Identifier, Production Identifier SUDID

8 EU MDR / IVD REGULATION EC Proposal MD Regulation Q EC UDI Recommendation April 2013 Trilogue of Commission, Parliament & Council October The legislative text to be finalized at the Trilogue meeting of December 3, Anticipate European Commission to release UDI regulation in Q1 of 2016 (effectivity Q2). 8 A Global View of UDI October 29, 2015 Confidential

9 CHINA FDA UDI REGULATION CFDA UDI Draft Rule in review Expect comment period after public release of the Draft Rule. Continuing Discussion: Acceptance of global UDI standard and National Code. CFDA considering issuing agency for National Code. UDI database approach in China similar to that of US FDA. Use of Global Medical Device Nomenclature (GMDN) and a national nomenclature, i.e., China Medical Device Nomenclature (CMDN). Already assigned CMDN to 20% of devices. 9 A Global View of UDI October 29, 2015 Confidential

10 TURKEY UDI PROGRAM All reimbursable medical devices must be identified and marked with GTIN or HIBC. Approximately 2.5 million approved medical devices in the Turkish TITUBB database (~92% GTIN) MoH is working on a new project UTS (a product tracking system) which will replace current TITUBB system. Main goal is to track products from manufacturing facility to end customer. Workshops with the industry to collect and give feedback to build the new system starting in September New UTS system is planned for June 2017 go-live. GMDN used as a nomenclature, GS1 GTIN or HIBC used for reimbursement. 10 A Global View of UDI October 29, 2015 Confidential

11 HEALTH CANADA UDI In the preliminary stages of considering how a UDI system may be implemented in Canada and will be developing a guidance document for industry over the next year or two (2015/2016). Implementation of any UDI-specific requirements would only be considered after stakeholders have had an opportunity to comment on the draft guidance document. Expect alignment on IMDRF UDI framework. 11 A Global View of UDI October 29, 2015 Confidential

12 INDIA MoHFW Drug and Cosmetic Rule June 2015 draft release provides 180 day implementation. GTIN, Batch/Lot, Serial, and UBD required in a 2 dimensional bar code on primary, secondary and tertiary packing level. Data hierarchy to be loaded into portal of the Central Government. 12 A Global View of UDI October 29, 2015 Confidential

13 Saudi Arabia Food and Drug Administration Aligned with US FDA / IMDRF UDI Requirements Data Submission and AIDC and use of HL7 SPL Phase I (Part I) Implement bar code readers at SFDA mobile App (for home use) Q (Part II) Consultation accreditation of issuing agency and regulation publication Q Phase II Create Saudi UDI Database Q Phase III Enforce UDI in phased approach Start Q Finish Q A Global View of UDI October 29, 2015 Confidential

14 BRAZIL ANVISA UDI Responsibility for UDI within ANVISA has recently changed. Draft UDI legislation may be available for public consultation the end of University working with ANVISA discussing the classification of medical devices with the assistance of GS1 Brazil. Discussions on appropriate use of GMDN continue. 14 A Global View of UDI October 29, 2015 Confidential

15 TAIWAN FDA UDI Taiwan FDA UDI Guidance of October 30, Implementation is voluntary. Provides references to US FDA UDI Rule and IMDRF UDI Guidance. References to using the same Issuing Agencies and format for UDI as FDA and IMDRF, GS1, HIBCC, ICCBBA. 15 A Global View of UDI October 29, 2015 Confidential

16 US FDA / IMDRF / EU COMM Requirement USA IMDRF EU Manufacturers responsible for assigning UDI based upon globally accepted coding standards such as GS1, HIBCC and ICCBBA Marking of UDI in human readable and auto-identification formats. AIDC technology requirements (linear bar code, 2D bar code, RFID) will remain technology neutral and based on ISO standards Reusable products requiring disinfection/sterilization between patients must have UDI Directly Marked on device Manufacturers / Labelers are responsible for submitting device data to UDI Database prior to product being placed on the market The UDI database will contain a consistent core set of predefined data elements - free text fields will be very limited FDA requires GMDN as an attribute of UDI, IMDRF allows GMDN to be optional, EU COMM nomenclature required. Manufacturing Date Exemption 16 A Global View of UDI October 29, 2015 Confidential

17 US FDA / IMDRF / EU COMM Requirement USA IMDRF EU The UDID shall use HL7 Structured Product Labeling (SPL) standard for? data submission and updates. UDI System shall include a robust transparent mechanism for evaluating and adjudicating requests for UDI exemptions and alternative placements of UDI-DI and UDI-PI. Labeling exception for both AIDC and HRI on Label if limiting constraints - AIDC format shall be favored for IMDRF, only AIDC for EU COMM. UDI required on label of individual packaged units w/in a multi-pack. IMDRF excludes class A and B / EU COM excludes class I & IIa. FDA only requires on implants. Retail POS Devices No Production Identifiers in AIDC. FDA only Class I Direct Marking requirements include both AIDC and Carrier. FDA is either / or, or both 17 A Global View of UDI October 29, 2015 Confidential

18 US FDA / IMDRF / EU COMM Requirement USA IMDRF EU Existing Inventory exemption 3 year inventory depletion period given IMDRF requires Serial Number for Active Implantable devices Orthopedic trays whose contents are configured for a specific order are exempt DI must be submitted (in DoC, Technical File) prior to approval of device 18 A Global View of UDI October 29, 2015 Confidential

19 BENEFITS OF UDI GLOBAL ALIGNMENT Provides for more efficiency, accuracy and automation of capturing product information in the global supply chain. Provides global visibility of device supply and movement through the healthcare supply chain to the patient. Provides global visibility to device adverse events and recalled devices. Provides a betters means to perform postmarket surveillance globally. Enables healthcare providers to auto-capture device information consistently and accurately in Electronic Healthcare Records. Enables capture of accurate and consistent device information in device registries globally. 19 A Global View of UDI October 29, 2015 Confidential

20 Jackie Rae Elkin Global Process Owner - Standard Product Identification Corporate Regulatory Operations Medt ronic 710 Medtronic Parkway, LS330 Minneapolis, MN, USA Office: Mobile: Fax: jackie.elkin@medtronic.com medtronic.com Facebook LinkedIn Twitter YouTube LET S TAKE HEALTHCARE FURTHER, TOGETHER