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‘Conference on International IVD Medical Devices Regulations’ to enhance international competitiveness of our IVD industry.

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2014-09-02
  • Last Updated:2024-04-25

The Food and Drug Administration (TFDA) of the Ministry of Health and Welfare hosted the ‘Conference on International IVD Medical Devices Regulations’ at the Taipei International Convention Center on September 2, inviting governing officials and business community experts of in vitro diagnostic devices (IVD) from five countries, including the United States, the United Kingdom, China, Australia and Indonesia, to participate and give lectures; over two hundred people from domestic industrial, academic, research and medical sectors have attended. Apart from gaining the latest information of international regulations, the conference provided domestic manufacturers with a communication platform on legal matters, facilitating the development of IVD industry in our country. 
The conference presented a rich program, with important speakers including officials from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Indonesian Ministry of Health (MOH), and President of the International Standards Organization (ISO) Clinical Laboratory Testing and In Vitro Diagnostic Test Systems Technical Committee (TC 212). Its topics include the latest IVD regulations in various countries, current status of major international markets such as EU and ASEAN, risk management of IVD, regulations on new product development technologies and clinical assessment, and so on. 

IVD is one of the main medical device exports of our country; the relevant international regulations and management trends directly affect the output value of domestic medical device industry. In view of this, TFDA pays considerable attention to the interaction of relevant international regulations, actively participates in related activities of the Asian medical device regulations reconciliation body, Asian Harmonization Working Party (AHWP), and leads its subordinate IVD working team under the technology committee to play an active role in the negotiation of IVD international regulations, hoping to provide the advantages for domestic IVD products to meet the requirements of international markets and to enhance international competitiveness of our medical device industry.