TGA News Issue 51 (November 2006) - International activity
GHTF update
At the recent Global Harmonization Task Force conference in Lubeck, two more documents from Study Group 1 of the GHTF were finalised and approved by the Steering Committee.
The first of these GHTF/SG1/N15:2006 - Principles of Medical Devices Classification is intended to assist a manufacturer to allocate a medical device to an appropriate risk class using a set of harmonised principles. Once assigned, such classification will prescribe how the manufacturer will demonstrate that the device complies with relevant regulatory requirements.
The Classification document should be read in conjunction with the second document approved, GHTF/SG1/N40:2006 Principles of Conformity Assessment for Medical Devices, which recommends conformity assessment requirements appropriate to each of the four risk classes proposed.
This link between documents on classification and conformity assessment is important to ensure a consistent approach across all countries/regions adopting the global regulatory model recommended by the GHTF, so that premarket approval for a particular device may become globally acceptable.
These two documents join the list of other SG 1 documents which form the basis of the pre-market elements of the GHTF regulatory model:
- SG1/N29:2005 - Information Document Concerning the Definition of the Term "Medical Device"
- SG1/N41:2005 - Essential Principles of Safety and Performance of Medical Devices
- SG1/N12:2000 - Role of Standards in Assessment of Medical Devices
- SG1/N43:2005 - Labelling for Medical Devices
International visitors & training
Dr John Lim, the newly appointed Chief Executive Officer of the Health Sciences Authority of Singapore, visited the TGA in July 2006 to discuss future collaboration under the existing Memorandum of Intention of Collaboration between the two agencies and the Mutual Recognition Agreement between the two countries.
Drs David Graham and Mark Doverty visited the US Food and Drug Administration and Health Canada in September 2006 to enhance the agency-level collaboration in relation to the regulation of therapeutic products.
Over the past few months, the TGA has hosted a number of short-term visits by officials from Vietnam, Korea, Singapore, China, Indonesia and the United Kingdom.
The TGA provided training to government officials from China, Botswana, Tanzania, Vietnam, Indonesia, and Saudi Arabia, on a cost recovery basis or with financial sponsorship from the World Health Organization or AusAID, in the areas of adverse drug reactions monitoring, biological products laboratory testing and counterfeit medicinal product control.