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AHWP

Asian Harmonization Working Party (AHWP)

Introduction

  • AHWP is an international cooperation organization established in 1996 to share information on the regulation of medical devices in 26 member countries, including Asian, African, Middle East and South American countries. It consists of medical device regulators and experts from the medical device industry.
  • AHWP has a Technical Committee and 10 working groups for regulatory approval (general medical devices, in vitro diagnostic products and software), quality control, post-approval controls, clinical studies, specifications, and so forth.

Scope of Activities

  • Sharing of information on regulation of medical devices in member countries
  • Cooperation with international organizations, such as IMDRF, OECD and WHO, for the purpose of international harmonization
  • Development of guidelines for the harmonization of regulatory requirements
  • Projects to reinforce the regulatory competence of regulatory authorities in member countries

Key activities

  • Elected as the chair of AHWP (2015~2017) in the 19th annual meeting of AHWP in 2014 to lead regulatory harmonization activities of member countries (November 2014)
  • Inauguration of the private-public partnership team for international cooperation (consisting of 139 experts from industry and related authorities), a mirror committee of the AHWP/IMDRF working group (January 2015)
  • Participation in the 7th to 9th regular meetings of IMDRF as representative of the AHWP (7th: Tokyo in March 2015, 8th: Kyoto in September 2015, 9th: Brasilia in March 2016)
  • Holding of 20th annual meeting of AHWP and 19th meeting of Technical Committee (Thailand, November 2015)
  • Participation in IMDRF's RPS working group(Regulated Product Submission) to represent the AHWP (December 2015)
  • Participation in OECD Regulatory Policy Committee's Network of Economic Regulators, Regulatory Policy Council and Meeting of International Organizations to represent the AHWP (April 10-17, 2016)
  • Holding of AHWP meeting and conference with regulators and industries (April 27-29, 2016)
  • Leading AHWP working groups to develop and revise international guidelines
  • Regular holding of teleconferences with IMDRF RPS working groups, OECD and WHO for international cooperation
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