TPKM/409
WTO/TBT
TW Taiwan
  • 11 - Health care technology
2020-06-06
2020-04-08

Medical equipment (ICS 11.040)

Medical Device Quality Management System Regulations (Draft) (24 page(s), in English; 24 page(s), in Chinese)

Based on Paragraph 1, Article 22 of the Medical Device Act, the Food and Drug Administration, Ministry of Health and Welfare, is proposing to conduct the Medical Device Quality Management System Regulations, which govern the quality aspects of the products.