TPKM/421
WTO/TBT
TW Taïwan
  • 11 - Technologies de la santé
2020-08-29
2020-07-01

Medical equipment (ICS 11.040)

Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing License (Draft) (8 page(s), in English; 6 page(s), in Chinese)

Based on Article 22, Paragraph 4 of the Medical Device Act, the Food and Drug Administration, Ministry of Health and Welfare, proposes to conduct the Regulation Governing the Inspection of Medical Device Quality Management System and the Issuance of the Manufacturing license, which govern the application procedures of inspection and other related matters.