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Global UDI Roll-out Map

Country status

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European Union

(updated 12/22/23)

2021 Oct – UDI/Device Voluntary Registration

2024 Jun – Development of Device and Vigilance Modules to be Completed

2027 Jun – EUDAMED to be Declared Fully Functional

2027 Dec – Mandatory use of Vigilance Module for Reporting

2029 Jun – Mandatory use of Device Module for Registration

Innovit Status: LIVE 

Submitter: Manufacturer (Actor/SRN)

Attribution: 109 attributes

Submission Type: Machine-to-Machine, Manual Entry

More Info: European Commission

Netherlands

(updated 12/22/23)

2018 Jul – Voluntary Registration for Class III Inclusion List products

2019 Jan – GS1 Netherlands enables GDSN connection to LIR

2020 Jan – Deadline National Implant Registry (LIR)

Innovit Status: LIVE 

Submitter: Manufacturer (Information Provider/GLN)

Attribution: 9 basic (~50 GDSN) attributes

Data Submission Type: Machine-to-Machine (GDSN), Manual Entry

More Info: GS1 Netherlands

Switzerland

(updated 12/22/23)

2021 May – Switzerland Mutual Recognition with Europe ceases.

2022 Apr – Development began of Swissmedic’s Swiss Database on Medical Devices

2024 Mar – Registration for Actors to open

2024 Jul – UDI Module to open

Innovit Status: MONITORING

Submitter: Manufacturer (Actor / CHRN)

Attribution: EUDAMED Based (~109)

Data Submission Type: Machine-to-Machine (GDSN), Manual Entry, Bulk Upload

More Info: Swissmedic

United Kingdom

(updated 12/22/23)

2021 Jan – UK-mfg Class I, Custom, IVD register

2021 May – III, IIb Imp, Active Imp, IVD A register

2021 Sep – IIb other, IIa, IVD B, IVD Self-test reg.

2022 Jan  – OUK-mfg Class I, Custom, IVD register

2023 Jul – CE replaced by UKCA mark; Legislation expected to require UDI

Innovit Status: MONITORING

Submitter: TBD

Attribution: TBD

Data Submission Type: TBD

More Info: Medicines & Healthcare products Regulatory Agency

China

(updated 12/26/23)

2019 Sep – Batch 1 Select Class III Devices

2022 Jun – Batch 2 Remaining Class III Devices

2024 Jun- Batch 3 Class II Devices

2026 Jun- Anticipated Date of Class I Devices

Innovit Status: LIVE

Submitter: License Holder / Agent (Company/USCC & GLN)

Attribution: 61 attributes

Data Submission Type: Machine-to-Machine, Manual Entry

More Info: GS1 China NMPA Registration

United States of America

(updated 12/22/23)

2013 Sep – UDI Final Rule Published

2014 Sep – Class III Devices Deadline

2015 Sep – I/LS/LS Devices Deadline

2016 Sep – Class II Devices Deadline

2022 Dec– Class I Devices Deadline (excluding Consumer Health Products)

Innovit Status: LIVE 

Submitter: Labeler (Labeler/DUNS)

Attribution: 57 attributes

Submission Type: Machine-to-Machine, Manual Entry

More Info: U.S. Food and Drug Administration GUDID

Saudi Arabia

(updated 12/26/23)

2022 May – Requirements Released (v4)

2022 Sept – Class B, C, D Devices (was 2021-Aug)

2023 Sept – Class A low-risk devices

Innovit Status: MONITORING

Submitter: Manufacturer (Authorized Representative/GHAD)

Attribution: 26-36 Attributes

Submission Type: Manual Entry, Bulk Upload

More Info: SFDA UDI Guidance MDS-REQ 7

South Korea

(updated 12/30/23)

2019 Jul – Class IV Devices

2020 Jul – Class III Devices

2021 Jul – Class II Devices

2022 Jul – Class I Devices

+1 year – Monthly Supply Report Req’d

Innovit Status: TESTING

Submitter: Manufacturer/Importer

Attribution: ~38 attributes

Submission Type: Machine-to-Machine, Manual Entry

More Info: Ministry of Food and Drug Safety

Brazil

(updated 12/26/23)

2021 Dec – Resolution RDC nº 591 ANVISA UDI Database

Effective Date + 2.5 Years – Class IV

Effective Date + 3 Years – Class III

Effective Date + 4 Years – Class II

Effective Date + 6 Years – Class I

Innovit Status: MONITORING

Submitter: Registration Holder / Manufacturer

Attribution: ~40 Attributes

Submission Type: TBD

More Info: Anvisa Brasil

India

(CDSCO)

2022 Jan (To Be Confirmed) – UDI Placed on Labels (may be delayed due to COVID)

 

Approach: Start with UDI on Medical Device Labels; Future expansion with UDI registration database

Info: CDSCO (Central Drugs Standard Control Organisation)

Australia

(updated 12/26/23)

2024 June – AusUDID Production Go-live

2025 Mar – Med Device Class III and IIb

2026 Mar – Med Device Class IIa

2027 Mar – Med Device Class Is & IVD Class 4 and Class 3

2028 Mar – IVD Class 2 and Class 1

Innovit Status: TESTING

Submitter: Manufacturer/Sponsor (Manufacturer/TBS Organisation ID)

Attribution: ~50 attributes

Submission Type: Machine-to-Machine, Bulk Upload, Manual Entry

More Info: Therapeutic Goods Administration

Japan

(PMDA)

2008 Mar – Guideline for Barcode Labelling

2019 Dec – PMD Act requires barcode labels and registration.

Approach: Report device info to database and apply barcode to labels for medical devices and IVDs; Future UDI reporting to UDI database

UDI Data: device registration includes: Product Code (DI), Expiry Data, Lot #, Serial #

UDI Label: HRI and AIDC (1D GTIN-128 barcode symbol or 2D); no Direct Marking now

STD: GS1

Info: PMDA (Pharmaceuticals & Medical Devices Agency)

Canada

(updated 12/26/23)

2021 Jun –  Proposal for Health Canada UDI Database

Innovit Status: MONITORING

Submitter: TBD

Attribution: TBD

Data Submission Type: TBD

More Info: Health Canada UDI Proposal

Colombia

 

Approach: Ongoing Medical Device UDI preparation; Plan to launch a country-specific guidance; Not expected to follow IMDRF UDI recommendations

Singapore

(updated 01/3/23)

2022 Nov – High-risk implantables for coronary stents, orthopedic joint replacement implants & intraocular lenses

2024 Nov – Class D (High-risk) for all general medical devices and in-vitro diagnostic (IVD) products

2026 Nov – Class C (Medium-risk) for all general medical devices and IVDs

2028 Nov – Class B (remaining) for all general medical devices and IVDs

Innovit Status: MONITORING

Submitter: Registrants, Local Manufactures, Importers

Attribution: 13

Data Submission Type: Manual, Excel Bulk Change

More Info: Health Science Authority (HSA) Singapore

Turkey

(UTS)

2007 TİTUBB Product code & database

2017 UTS – Product Track & Trace System No machine to machine data exchange capability planed.

 

Approach:To keep record of medical devices and cosmetic products. Establishing a National and Original infrastructure that can keep track of products. Ensure patient safety and protection of public health with efficient execution of inspection services. Achieve rapid measures for possible risks occur during use of the products.

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