Medical Product and Device Listing
Return to RCRIM Page Regulated Clinical Research Information Management Project Number: 325
Project Name Medical Product and Device Listing
Project Sponsor(s) RCRIM Work Group
Contents
Description
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.
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.
