Updates on Asian Harmonization of Medical Devices Regulations Meeting

The Asian Harmonization Working Party (AHWP) met in March 2008 in Malaysia. In addition to discussing updates of the AHWP Technical Committee (TC), members also discussed updates on the Global Harmonization Task Force (GHTF) during the 4th APEC funded seminar.

The six working groups under the TC have now been established with head chairs. These working groups are:

  1. Pre-market Submission and CSDT (Common Submission Dossier Template)
  2. Post Market Surveillance and SADS
  3. Quality Management System
  4. Quality System Audits
  5. Clinical Evidence Requirements
  6. Capacity Building and Regulatory Training

In addition, AHWP has also established a Special Task Group on Nomenclature.

Each working group is now currently recruiting additional members to carry out its assigned task. AHWP hopes to finalize members in each working group by the end of this year. Other plans include incorporating IVD device regulations, reviewing nomenclature, addressing quality system requirements, and more.

Participants also discussed establishing an educational training program geared towards global regulatory issues. AHWP is currently collaborating with Northeastern University to develop this program. The curriculum would include courses on the GHTF and AHWP members’ regulatory systems, such as China, India, and Japan.

The APEC-funded seminar discussed quality systems, roles of standards, and labeling. For 2008, GHTF plans to issue final documents for In Vitro Diagnostic Medical Devices. These documents include classification of IVD devices and conformity assessment.