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Medical Product and Device Listing

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Project Number: 325

Project Name: Medical Product and Device Listing

Project Sponsor(s): RCRIM Work Group


This project will develop a standardized specification of the data elements and exchange format for the transmission of information that uniquely and certainly identifiers a medical product or device, wherever authorized for marketing, for the purposes of product listing/registration. The project will further provide references to other standards and external terminology resources required to populate the data elements defined in the standard. Medical products will be the initial focus of the project. The work is based on existing work efforts: ISO/TC 215/SC WG6 N 547 (Health Informatics: IS#11615 Identification of Medicinal Products - Data Elements and Structure for the exchange of product information for drug dictionaries) and HL7 Structured Product Labeling.

Medical Product Information (includes Drugs, Devices, Biologics, Veterinary Products) (SPLr5) Approved by RCRIM Feburary 2, 2010

More information can be found at the wiki Structured_Product_Labeling

Objectives / Deliverables

Improve medical product and device listing processes

In the context of the regulation of medical products and devices, it is necessary to put in place a mechanism whereby a list of products available in a specific country or region can be identified uniquely and with certainty.

Improve identification of medical products and devices across countries and regions

The data structure along with the controlled vocabularies provides a mechanism to enable information uniquely identifying a medical product or device, regardless of where the product is authorized, to be exchanged between regulators and to all other interested stakeholders.

Improve protection of public health

Such identification contributes to improved protection of public health by allowing many healthcare and health product regulatory activities such as monitoring safety of products (e.g., pharmacovigilance), electronic prescribing, and ensuring product quality to be undertaken with increased efficacy and certainty.

Project Scope Details

Project Facilitator: Ed Tripp

SD Approval Date: Feb 20, 2008

TSC Approval Date Jun 2, 2008

PMO Approval Date: Jun 2, 2008

Target Date: Normative

Project Intent Revise Current Standard

Project Intent Notes This project involves potential extensions to the HL7 Structured Product Labeling standard

Collaboration Efforts ISO TC 215 CEN

Dependancies - Structured Product Labeling - Medical product terminology project

Start Date Feb 20, 2008

Current Status

On hold pending outcomes of the Common Product Model which is a joint effort between RCRIM, Orders & Observations, Pharmacy and Patient Safety. If the four workgroups can successfully develop a common product model then this project will be closed.