Public safety and healthcare are among the main responsibilities of all governments. Therefore, the European Commission has engaged several policy and regulatory dialogues with the EU’s key trade partners in medical technology.
Discussions and exchanges of ideas were pursued mainly with the US Food and Drug Administration (FDA), Japan Ministry of Health, Labour and Welfare (MHLW) , Health/Santé Canada, Australia Therapeutic Goods Administration (TGA), China Food and Drug Administration (SFDA) and China Quality Supervision, Inspection and Quarantine (AQSIQ). The regulatory dialogues on health technology are also active under political umbrellas such as the Transatlantic and Trade Agreement (T-TIP) with the USA, the Free Trade Agreement (FTA) with Japan or the Revised Mutual Recognition Agreement with Australia (Revised MRA).
The cooperation also takes place within a multilateral framework, the International Medical Device Regulators’ Forum (IMDRF). The IMDRF includes representatives from: Australia, Brazil, Canada, China, the EU, Japan, the Russian Federation, and the USA. The World Health Organization (WHO) and the Asian-Pacific Economic Cooperation (APEC) are official observers.
The EU’s participation in IMDRF helps to accelerate international medical device regulatory convergence. In this way, the requirements and approaches become more aligned by adopting the same technical documents, standards, scientific principles, and similar regulatory practices and procedures.
IMDRF member competent authorities