Global UDI Timeline

Your Critical Path to UDI Key dates around the world

This page is a summary of UDI compliance deadlines at the country level. As each country’s regulator make changes to their implementation timelines we will update this page. Mark this page in your favourites to keep track of developments.

Country-specific UDI Requirements

COMPLETED

USA FDA

USA
  • 2013 Sep 24

    UDI Final Rule Published

  • 2014 Sep 24

    Class III Devices

  • 2015 Sep 24

    I/LS/LS Devices

  • 2016 Sep 24

    Class II Devices

  • 2022 Dec 8

    Class I Devices

Türkiye UTS

USA
  • 2017 Sept 11

    Optics (Lens and Spectacles)

  • 2018 Jan 01

    Active Implantable Medical Devices

  • 2018 Jun 01

    Class III

  • 2019 Jun 01

    Class II

  • 2022 Jan 01

    Class I

IN PROGRESS

South Korea MFDS

USA
  • 2019 Oct 01

    Class IV

  • 2020 July 01

    Class III

  • 2021 July 01

    Class II

  • 2022 July 01

    Class I

China NMPA, NHC & NMIA

USA
  • 2019

    UDI Pilot, Rules, UDID Database Tests

    2019 Sep 17

    Batch 1 Notice timing and list

  • 2020 Sep 30

    Batch 1 Delay & 69 (64+5) categories

  • 2021 Jan 01

    Batch 1 UDI Data & Label Req’d

  • 2022 Jan 01

    Phase 2 Remaining Class III

  • TBC

    Class II devices Class I and Remaining devices

EU EC

USA
  • 2020 Dec 01

    Actor Voluntary Registration

  • 2021 May 26

    MDR DoA, Class I Self-certification

    2021 Oct 4

    UDI/Device Voluntary Registration

  • 2022 May 26

    IVDR DoA

    2022 – end

    Vigilance, Clin Invest, Mkt Survey Modules (voluntary)

  • 2024 Q2

    Fully functional EUDAMED system released into production

    2024 Q4

    Use of EUDAMED mandatory for modules (Actors, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance)

  • 2026 Q2

    Use of EUDAMED mandatory for modules (UDI/Device and NB & Certificate)

  • 31 December 2027

    Higher risk devices Class III & II (b)

  • 31 December 2028

    Med – lower risk devices. II (b), II (a) & I (s/m/r)

UK MHRA

USA
  • 2021 Jan 01

    Brexit effective, Guidance Released

    2021 Jan 01

    UK-mfg Class I, Custom, IVD register

    2021 May 01

    III, IIb Imp, Active Imp, IVD A register

    2021 Sep 01

    IIb other, IIa, IVD B, IVD Self-test reg.

  • 2022 Jan 01

    OUK-mfg Class I, Custom, IVD register

  • 2023 Jul 01

    CE replaced by UKCA mark; Legislation expected to require UDI

Singapore HSA

USA
  • 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

Saudi Arabia SFDA

USA
  • 2019 Apr 08

    UDI Draft Requirements released

  • 2019 – 2020

    UDI Pilot

  • 2020 Sep 06

    UDI Formal Requirements (v3) released

  • 2023 Sept

    Class B, C and D devices

  • 2024 Sept

    low-risk Class A devices

Brazil ANVISA

USA
  • 2021 Dec 29

    ANVISA UDI regulations published

  • 2.5 years post-publication

    risk class IV medical devices

  • 3 years post-publication

    risk class III medical devices

  • 4 years post-publication

    risk class II medical devices

  • 6 years post-publication

    risk class I medical devices

Australia TGA

USA
  • 2019 Jan

    UDI System Proposal

  • 2020 Sep

    UDI Consultation Survey

  • 2021 Feb

    Therapeutic Goods Amendment establish AusUDID

  • 2022 Jun

    Sandpit (beta) version of the Australian UDI database (for general use and testing)

    2022 Jun

    Third consultation paper

  • 2023 Jan

    Voluntary compliance (Regulations in effect) for high risk devices (Class II, III, AIMD)

  • 2024 Jul

    Mandatory compliance for implantable devices. Allocation of UDIs, UDIs on labelling, and provision of data.

Netherlands VWS

USA
  • 2018 Jul 01

    MFR voluntarily apply UDI on label of Inclusion List products

  • 2019 Jan 01

    National Implant Registry (LIR) started

  • 2020 Jan 01

    Healthcare providers must register patient implant data in LIR referencing UDI product data published by MFR in the “GS1 Data Source”

    2020 Jan 01

    By implication Mfr required to report UDI data to GS1 Data Source and apply UDI on label of Inclusion List products

  • TBD

    National Implant Registry live and will remain in place. Netherlands will look to follow the EU/EUDAMED for additional UDI requirements.

Taiwan NHI

USA
  • 2021 May 01

    Medical Devices Act governing medical devices officially took effect.

  • 2022 Jun 01

    Class III Medical Devices – UDI database registration & label required.

  • 2023 Jun 01

    Class II Medical Devices – UDI database registration & label required.

  • TBD

    Class I Medical Devices

Switzerland Swissmedic

USA
  • 2022 Apr

    Implementation of the “Swiss Database on Medical Devices” aka “SwissDAMED” started by Swissmedic.

  • 2023 Q3

    Actor registration possible.

  • 2024 Summer

    Product registration possible (on a voluntary basis).

  • TBD

    “Actor Module” in development.