Historical Development

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

The Global 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 GHWP meeting in Sydney, Australia; the GHWP 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 GHWP. GHWP is fortunate to be able to align itself to the harmonization efforts and meetings of GHTF. Since 1998, GHWP 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 GHWP Chair. The draft "Terms of Reference" for how the GHWP was to function as formal regional grouping in Asia were reviewed and adopted in the Bethesda meeting.

In September 2000, at the Ottawa, Canada, GHWP meeting the GHWP member economies formally elected Dr. Tan as the Chairman for a three-year term. This was an important development for GHWP as it is now formally constituted with members and the purpose and the framework and procedures of GHWP 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 GHWP also established a Technical Committee and elected the Technical Committee leadership.

The new office bearers for the second term of GHWP and its Technical Committee were elected on 14 June 2005 during an GHWP 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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