- Regulatory framework
- Specific areas of development
- Market surveillance and vigilance
- Scientific and technical assessment
- Other related policies
- Dialogue between interested parties
- International Cooperation
The concerns of public safety and healthcare are normally shared by all governments. This is why the European Commission has engaged in a number of policy and regulatory dialogues with its counterparts in the key trade partners of the EU in the field of medical technology.
This bilateral cooperation is mainly carried out with the US Food and Drug Administration (FDA), Japan MHLW, Health Canada, Australia TGA, China SFDA and AQSIQ. The bilateral cooperation with Australia, Canada, Japan and the USA feeds a multilateral framework i.e. GHTF (the Global Harmonization Task Force). The active participation of Europe in GHTF aims at contributing to the definition of a global regulatory model for medical device and diagnostics technology and the drafting of guidance documents agreed by consensus.
More detailed Information on the multilateral and bilateral policy and regulatory dialogues can be found under the following headings: