2012 Working Group Report The Working Group on Medical Measurements The Nineteenth Forum Meeting Nov 7, 2012 Brian C.S. Shu

2  Application for APEC TILF Special Account fund  Review APLMF Guide Drafted by WG on Metrological Control System  OIML TC18/SC1 “blood pressure instruments” meeting  2013 Working Plan Overview

3 Workshop on Regulatory Approach to clinical Thermometer Why APEC should undertake the project ？  the importance of work on standards and conformance to reduce the impact of non-tariff barriers on free and open trade and investment have been acknowledged by APEC leaders in 2010

4 Workshop on Regulatory Approach to clinical Thermometer Why the project is so important ？  the primary tools for patient screening at early stage  thermometer market scale in Asia has been increasing /infrared ear thermometer market scale in eleven APEC economies is predicted to reach the growth rate of 12.6% in 2015  Duplicate controls and lack of well recognized international standard certainly affect the trade of infrared ear thermometer among the region..

5 Workshop on Regulatory Approach to clinical Thermometer Objectives  reduce the impact of non-tariff barriers on free trade  improve the accuracy of infrared ear thermometer  bridge the dialogue between health authorities and metrology authorities to reduce duplicate controls.  participants receive in depth knowledge of existed standards and their difference

6 Workshop on Regulatory Approach to clinical Thermometer How the workshop will help achieve APEC’s key priorities reduce the impact of non-tariff barriers on free trade ？  At their 2010 meeting in Yokohama, APEC leaders called for regulatory cooperation to be “broadened and deepened” specifically noting that “trade costs should be minimized and bureaucratic inefficiencies removed.”  Promoting regulatory cooperation and convergence through APEC also works towards the objectives outlined in the WTO Agreement on Technical Barriers to Trade.

7 Workshop on Regulatory Approach to clinical Thermometer How the workshop will meet forum’s work-plan or medium-term plan ？  The project will develop a shared understanding of control schemes, standards to increase transparency and promote better technical requirements.  This workshop supports capacity-building activities including exchanging views and experience on best practices from health and metrology authorities

8 Workshop on Regulatory Approach to clinical Thermometer Implementing plan  Design and disseminate the questionnaire to seek comments on contents/topics of the programs mentioned above, and identify appropriate trainers/experts/speakers to attend the activities;  A “workshop” on regulatory Approach to clinic thermometers. This workshop supports capacity-building activities including exchanging views and experience on best practices from health and metrology authorities

9 Review APLMF Guide Drafted by WG on Metrological Control System  Guide to the Application of ionizing radiation metrology in medicine under legal metrological system  Recommendation to Change The definition of special term such as ionizing radiation, traceability and so on. Avoid duplicate control Reference standards

10 OIML TC18/SC1 “blood pressure instruments” meeting  Discuss 77 comments on OIML R16-1 and and 177 comments on16-2  Agreements have reached such as technical requirements of non-invasive sphygmomanometers technical requirements of Patient simulators the range of temperature and humidity for testing non- invasive automated sphygmomanometers new committee draft will be established at the end of this yea

11 Review APLMF Guide Drafted by WG on Metrological Control System  Guide to the Application of ionizing radiation metrology in medicine under legal metrological system  Recommendation to Change The definition of special term such as ionizing radiation, traceability and so on. Avoid duplicate control Reference standards

12  Seek APEC fund to hold a workshop regarding on duplicate control on measurement device in medicine Update Surveys Collect measurement device in medicine controlled by metrology authorities Formulate and present a concept note to APEC  Working with WG on Metrological Control System to draft a guideline of complementary control on Medical Device  Update the work of OIML TC 18/SC 1: Blood pressure instruments 2013 Work plan

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