Historical Development

Submitted by admin on Tue, 09/20/2016 - 00:55

The Asian Harmonization Working Party was formed around 1996-97 by a group of committed regulatory affairs professionals in Asia Pacific from the growing interest of regulators in working towards greater harmonization of medical device regulations in Asia.

The first several meetings were difficult as no one really knew what harmonization meant or how to participate. Also, most of the economies involved in the meetings either had no medical device regulations or their regulations were new and developing.

After the 1998 AHWP meeting in Sydney, Australia; the AHWP member economies began to latch onto the principles that the GHTF was fostering on harmonization and cooperation. The concept of a regional organization for Asia with linkage to GHTF to work towards greater harmonization of medical device regulations, began to make sense to many Asian regulators and they began to take an active role in the AHWP. AHWP is fortunate to be able to align itself to the harmonization efforts and meetings of GHTF. Since 1998, AHWP meetings have been held in conjunction with GHTF conferences.

In Bethesda, Maryland, USA, June 1999, the member economies from Asia elected by consensus Dr. Clarence Tan, of the Singapore Ministry of Health, as protem AHWP Chair. The draft "Terms of Reference" for how the AHWP was to function as formal regional grouping in Asia were reviewed and adopted in the Bethesda meeting.

In September 2000, at the Ottawa, Canada, AHWP meeting the AHWP member economies formally elected Dr. Tan as the Chairman for a three-year term. This was an important development for AHWP as it is now formally constituted with members and the purpose and the framework and procedures of AHWP working are established as in its Terms of Reference. The member economies also announced their official representatives (one regulator and one from industry appointed by the regulator). The AHWP also established a Technical Committee and elected the Technical Committee leadership.

The new office bearers for the second term of AHWP and its Technical Committee were elected on 14 June 2005 during an AHWP meeting held in conjunction with the 3rd APEC-funded Seminar on Harmonization of Medical Device Regulation, 13-17 June 2005, Bangkok, Thailand. They assume the 3-year term of office with effect from 14 June 2005.


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