The Development for guideline of raw matrials on technical document of Medical Device |
Park, Ki-Jung
(Phamaceuticals & Medical Device Research Department, National Institute of Food and Drug Safety Evaluation)
Ryu, Gyu-Ha (Medical Device Safety Bureau, Korea Food and Drug Administration) Lee, Sung-Hee (Medical Device Safety Bureau, Korea Food and Drug Administration) Lee, Chang-Hyung (Medical Device Safety Bureau, Korea Food and Drug Administration) Jung, Jin-Baek (Phamaceuticals & Medical Device Research Department, National Institute of Food and Drug Safety Evaluation) Lee, Jae-Keun (Seoul Metropolitan Korea Food and Drug Administration) Hur, Chan-Hoi (Phamaceuticals & Medical Device Research Department, National Institute of Food and Drug Safety Evaluation) Kim, Hyung-Bum (Medical Device Safety Bureau, Korea Food and Drug Administration) Choi, Min-Yong (Medical Device Safety Bureau, Korea Food and Drug Administration) Kim, Yong-Woo (Medical Device Safety Bureau, Korea Food and Drug Administration) Hwang, Sang-Yeon (Medical Device Safety Bureau, Korea Food and Drug Administration) Jung, Jae-Hoon (Medical Device Safety Bureau, Korea Food and Drug Administration) Koo, Ja-Jung (Medical Device Safety Bureau, Korea Food and Drug Administration) Hong, Hye-Kyung (Medical Device Safety Bureau, Korea Food and Drug Administration) Lim, Kyung-Taek (Medical Device Safety Bureau, Korea Food and Drug Administration) Kang, Se-Ku (Medical Device Safety Bureau, Korea Food and Drug Administration) Kwak, Young-Ji (Daegu Metropolitan Korea Food and Drug Administration) |
1 | ISO 10993-1 "Biological evaluation of medical devices - Part 1 : Evaluation and testing" |
2 | "Descriptions of Raw Materials on Medical Device Manufacturing (Import) Approval Application Form (2004.11.15.)", Ministry of Health, labour and Welfare of Japan. |
3 | ISO 10993-18 "Biological evaluation of medical devices - Part 18 : Chemical characterization of materials" |