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European Union

2020 Dec – Actor Voluntary Registration

2021 May – MDR DoA, Class I Self-certification

2021 Oct – 2023 end – UDI/Device Voluntary Registration

2022 May – IVDR DoA

2022 – end – Vigilance, Clin Invest, Mkt Survey Modules (voluntary)

2023-mid: EUDAMED fully functional notice

2023-end to 2025 mid: Mandatory Registration period or upon Series Incident / EUDAMED Production Begins

 

Approach: MDR/IVDR revamped regulatory framework; Register device/UDI data & apply UDI to labels per Legacy, MDR, IVDR rules and timing

UDI Data: 109 attributes to EUDAMED; New BUDI-DI group concept

Data Sub: Website entry/XML file upload or electronic M2M XML file transfer via Data Exchange to EUDAMED

UDI Label: HRI & AIDC by class (III-2021, IIa/b-2023, I-2025;D-2023, B/C-2025, A-2027); MD Direct Mark (Label + 2yr)

STD: GS1/HIBCC/ICCBBA/IFA; SRN; EMDN

Info: EC Reg, UDI (European Commission)

Netherlands

(VWS)

2018 Jul – Mfr voluntarily apply UDI on label of Inclusion List products

2019 Jan –National Implant Registry (LIR) started

2020 Jan – Healthcare providers must register patient implant data in LIR referencing UDI product data published by Mfr in the “GS1 Data Source”

2020 Jan – By implication Mfr required to report UDI data to GS1 Data Source and apply UDI on label of Inclusion List products    

Approach: Start UDI prior to EU timeline with devices on “Inclusion List” (~500 Class III and IIb implants)

UDI Data: 9 basic (~50 GDSN) attributes reported to Interim Central Article Database (GS1 Data Source)

Data Sub: Website entry or electronic GDSN to “GS1 Data Source”

UDI Label: HRI & AIDC (1D or DataMatrix); include ID (and Lot #, Expiry Date, Serial # as req’d)

STD: GS1/HIBCC/ICCBBA

Info: Dutch National Implant Register (LIR) VWS – Ministry of Health, Welfare and Sport

Switzerland

(Swiss AR)

2021 May – Switzerland Mutual Recognition with Europe ceases.

2021 May – Swiss importer must be identified on the device, its packaging or in a document accompanying the device for MDR compliant devices

2022 March – Swiss AR appointment deadline for Class II b non-implantable/II a devices; must add Swiss AR to labelling

2022 March – deadline for Class C & B IVDs.

2022 July – appointment deadline for Class I devices; must add Swiss AR to labelling

2022 July – Swiss importer must be identified on the device, it’s packaging or in a document accompanying the device for MDD compliant devices.

2022 Nov – Swiss registration deadline for IVDR CE marked devices which were already placed on the market before 26 May 2022.

2022 Dec– Swiss AR appointment deadline for Class D IVDs.

   

Approach: Non-Swiss companies will require a Swiss AR & Swiss Importer to market in Switzerland; Swiss manufacturers require an EU Authorized Representative and EU Importer to market in Europe.

United Kingdom

(MHRA)

2021 Jan  – Brexit effective, Guidance Released

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

 

Approach: UK regulatory framework revamped due to Brexit; Mfrs & Devices must be registered in MHRA; GB will NOT comply with EU MDR/IVDR (Northern Ireland will); UDI voluntary field – future UDI legislation will require UDI.

UDI Data: ~70 attributes similar to EU reported to DORS (Device Online Reg. System) includes BUDI

Data Sub: Website manual entry or XLS upload (1,000 max records); (perhaps M2M in the future)

UDI Label: HRI & AIDC

STD: GS1/HIBCC/ICCBBA/IFA; GMDN, UKCA

Info: MHRA Medical Devices (Medicines and Healthcare products Regulatory Agency)

   

(NHS-England)

2014 Apr – NHS eProcurement Strategy

2017 Sep 30 – Class III Devices UDI Data & Labels req’d

2018 Sep 30– Class IIa/b Devices

2019 Sep 30 – Class I Devices

2021 Sep 30 – Class A, B, C, D IVD Devices

   

Approach: Customer (buyer) business initiative (not a MHRA regulatory requirement) to require electronic UDI product data & UDI labels and use of PEPPOL network for procurement transactions (slow adoption, paused due to COVID)

UDI Data: 60 attributes published to NHS via GDSN

Data Sub: GDSN (product); PEPPOL (orders)

UDI Label: HRI & AIDC; Direct Mark

STD: GS1 only (GTIN and GDSN required)

Info: Scan4Safety (NHS – National Health Service)

china

(NMPA)

2019 2H – UDI Pilot, Rules, UDID Database Tests

2019 Sep – Batch 1 Notice timing and list

2020 Sep – Batch 1 Delay & 69 (64+5) categories

2021 Jan – Batch 1 UDI Data & Label Req’d

2022 Jun – Batch 2 (Remaining Class III)

TBD – Class II Devices

TBD – Class I and Remaining Devices

 

Approach: Started UDI data registration and UDI labels with Batch 1 (69 categories of Class III high risk Implantables), Expand by classes

UDI Data: 61 data attributes reported to UDID; (no BUDI)

Data Sub: Website entry/XLS file upload or M2M XML transfer via API to UDID by Local Rep

UDI Label: HRI & AIDC (1D or 2D barcode)

STD: GS1 China, ZIIOT, Ali Health Mashangfangxin Platform

Info: NMPA (National Medical Products Administration)

United States of America

2013 Sep – UDI Final Rule Published

2014 Sep – Class III Devices

2015 Sep – I/LS/LS Devices

2016 Sep – Class II Devices

2022 Sep  – Class I Devices

 

Approach: UDI layered on top of existing device registration; Report UDI Data & apply UDI to Labels by class

UDI Data: 57 attributes to GUDID

Data Sub: Website entry or electronic M2M SPL file via ESG

UDI Label: HRI & AIDC; Direct Mark

STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA

Info: FDA UDI (Food and Drug Administration)

Saudi Arabia

(SFDA)

2019 Apr – UDI Draft Reqm’ts released

2019/2020 – UDI Pilot

2020 Sep – UDI Formal Reqm’ts (v3) released

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

2023 Sept – Class A low-risk devices

 

Approach: UDI similar to EU regulation; Import and Track & Trace modules with Lot/SN reporting on hold

UDI Data: 43 attributes to Saudi-DI database; (no BUDI)

Data Sub: website entry; expect XLS upload; (perhaps electronic M2M API transfer?)

UDI Label: HRI & AIDC, Direct Mark; Unique DI with PI (Lot #, Serial #, Exp Data, Mfg Date conditional)

STD: GS1/HIBCC/ICCBBA

Info: SFDA (Saudi Food and Drug Authority)

South Korea

(MFDS)

2018/2020 – Guidelines for Barcodes & UDI codes

2019 Jul – Class IV Devices UDI Labeling Req’d

2019 Oct – Class IV Devices UDI Data Req’d

2020 Jul – Class III Devices

2021 Jul – Class II Devices

2022 Jul – Class I Devices

+1 year – Monthly Supply Report Req’d

   

Approach: UDI data reporting and UDI label by class AND submit Supply Report (Track & Trace) of ~10 distribution metrics each month UDI Data: 40 attributes to IMDIS (Integrated Medical Device Information System); (no BUDI)

Data Sub: website XLS download/complete data/upload file or M2M XML transfer via API by Local Rep

UDI Label: HRI & AIDC, Direct Mark

STD: GS1 (default), HIBCC & ICCBBA (special)

Info:MFDS, IMDIS UDI System (Ministry of Food and & Drug Safety)

Brazil

(ANVISA)

2018 Jun – UDI Barcode Initial Pilot
2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data reported to RNI by healthcare provider
2021 Feb – UDI System Publication
2023? – Class IV Devices
2024? – Class III Devices
2025? – Class II Devices
2027? – Class I Devices

   

Approach:

Pilot started with package UDI barcodes on Coronary Artery Stents and Hip & Knee Arthroplasty Implants

UDI Data:

Few attributes reported by healthcare provider to National Implant Registry (RNI) UDI Label: DI, Expiry Date, Lot/SN in AIDC (1D or 2D barcode) on (3) Mfr-supplied “Traceability Labels” with product pkg

STD:

GS1/HIBCC Info: ANVISA (National Health Surveillance Agency)

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

(TGA)

2019 Jan – UDI System Proposal

2020 Sep – UDI Consultation Survey

2021 Feb – Therapeutic Goods Amendment establish AusUDID

TBD – Phased UDI, not before EU dates (+1 yr?)

Approach: Similar to EU regulation; UDI/Device registration

andUDI labels implemented by MD and IVD classes

UDI Data: “EU-like” attributes reported to AusUDID; BUDI-DI?

UDI Label: HRI & AIDC; Direct Mark

STD: GS1/HIBCC/ICCBBA, EMDN/GMDN?

Info: TGA Medical Device & IVD (Therapeutic GoodsAdministration)

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

(Health Canada)

2021 – Expected HC UDI Notice

 

Approach: Ongoing UDI preparation; Expected to follow IMDRF UDI recommendations

Colombia

   

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

Singapore

(HSA)

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

Approach: HSA UDI compliance for low-risk Class A devices will be voluntary, according to the guidance. Devices intended for clinical trials, clinical research or investigational testing as well as custom-made devices will be exempt from HSA UDI requirements. Devices marketed in Singapore via Special Access Routes will have to comply with UDI rules.

   

Singapore market registrants selling Class B, C & D devices can begin submitting UDI Device Identifier data into HSA’s Medical Device Information and Communication System (MEDICS) online submission system on August 31, 2021.

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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