FDA Circular "Guidelines on the Regulation of Medical Device Software (MDSW) by the Food and Drug Administration (FDA)"; (7 page(s), in English)
27 พฤษภาคม 2568

แจ้งเวียนกฎระเบียบอื่น ๆ

30 มิ.ย. 65

Technical Regulation for Pressure Equipment; (70 page(s), in Arabic)
10 มี.ค. 68

SI 1268 Part 5 - Syringes and needles: Sterile single-use syringes, with or without needle, for insulin
04 ส.ค. 66

Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use; (91 page(s), in English)