Canada Regulatory

UDI DEVLOPMENTS

REGULATORY AGENCY	Health Canada
REGULATION NAME	Unique Device Identification Rule Draft
COMPLIANCE DATES	2023: Class IV medical device implementation (UDI and nomenclature) date 2025: Class III medical device implementation (UDI and nomenclature) date 2027: Class II medical device implementation (UDI and nomenclature) date & hospital/SSO EHR/ERP integration date 2030: Hospital/SSO implementation (UDI and nomenclature) date
APPLIES TO	It is anticipated that all stakeholders throughout the medical device lifecycle will be affected by the implementation of UDI. This would include patients, health care professionals, hospital administrators, researchers, manufacturers, provincial and territorial governments, as well as Health Canada, the federal regulator.

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID)
BARCODE CONTENTS	GTIN(AI 01) Serial number(AI 21) Batch number(AI 10) Expiry date(AI 17)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES
FREE SAMPLES MUST BE MARKED?	Not Specified

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY	GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (GUDID :- The Global Unique Device Identification Database )
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	Not Specified
SEND UNIT DATA TO TRADING PARTNER?	Not Specified
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	Not Specified
SEND AGGREGATION DATA TO TRADING PARTNER?	Not Specified

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	Health Canada
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes (Import & Exports)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	Yes

DRAFT GUIDANCE

REGULATORY AGENCY	Health Canada
REGULATION NAME	Electronic Media in prescription drug labelling
COMPLIANCE DATES	For Manufacturer deadline December 31, 2021 – the deadline can be extended to 2023 if manufacture is not ready For Distributors the deadline to be ready to scan and implement in the system GS1 DataMatrix is Dec 31, 2023. For Pharmacies the deadline to be ready to scan and implement in the system GS1 DataMatrix is Dec 31, 2025
APPLIES TO	Canada’s proposed regulations will apply to all categories of pharmaceuticals

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY	2D Bar code : GS1 Data Matrix
BARCODE CONTENTS	2D barcode Web address/URL 2D Barcodes that contain a Global Trade Item Number (GTIN) lot number Expiry date. Serial numbers
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standard
PRODUCT CODE NOTES	NA
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

Parent-Child Mapping Aggregation Capture?

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	NA
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As Applicable
SEND UNIT DATA TO TRADING PARTNER?	As Applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	NA
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As Applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As Applicable

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	Health Canada
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes (Import & Exports)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	NA
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	NA

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	NA
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	NA

Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

DISCLAIMER

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

ABOUT KEVISION SYSTEMS

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in