4月号 - 日本医療機器産業連合会
Contents
1. lt2. HHHHH 18 89 2015 APRIL 4 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA QMS
3. 3
4. 14 4
5. AG aa a 6 89 201542 APRIL Ohhh 1
6. ooo he HOS
7. 2 2 26 11
8. 1 2 3
9. 2
10. eas a as ae RUT I 74 R F RWIO Ee CHB MIROMReE SUI EBE HUT 7 Vat RCA
11. 89 2015 APRIL 73 hhh 1 2
12. Lawes 3 1
13. 6 IT 2
14. 27 4 1 AMED PMDA 5 2 4 27 1
15. 4 26 27 4 AMED Japan Agency for Medical Research and Development
16. 25 11 27 26 11 25 1 2 3
17. 22
18. 3 4 89 2015 APRIL hhh
19. 19 6 Ver1 02 6 25
20. RU Sie 3 1 1
21. HHHHL T 856 0026 2 1303 8 TEL 0957 52 1138 FAX 0957 52 1140 E mail innovation joho nagasaki or jp URL https www joho nagasak1 or p 68 895 201542 APRIL hhh uuu 1 25 9
22. 26 11 14 1114 5 2
23. 5
24. 89 2015 APRIL 71 Uhhh 2 1
25. 27 4 AMED 19
26. GO 9 Aa 2 70 1 X
27. 89 201542 APRIL 75 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 2 23
28. 89 2015 APRIL hhh 27 1 MDPRO Medical Device Industrial Policy Research Office UDI
29. 26 10 I 2 19 26 89 2015 APRIL 15 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA A 5 es 653 oo 2
30. MC Dt OR RAH SME LE IMDRE GHTF IMDRE ICH OE CD GUE 44 A895 2015 APRIL hhh Stakeholder Forum 5 MDSAP MDSAP 2012 2014 1 2013 6 18 4 2 6
31. 26 250 24 160 SN EE 25
32. 2 1 2 3 1 2 x O 89 2015 APRIL 5 7 hhh UDI
33. 1 PMDA HP IV
34. Q3 QMS es CAPA FDA 05 ISO oe a em a a ST a FE FE yd r ER ES 0 50 100 150 200 20 89 201542 APRIL hhh 3 QMS QMS
35. F 18 X CT JIRA X X CT SoH EST RSE ie MRI CL Ni CPAP
36. 1 URL http platinum mri co jp platinumr society 7preface index 2 23
37. 23 11 62 89 2015 APRIL hhh 4 ROE BB I 7 4 KA F BU SL WFC OR 2 Bap iC LC SR KIC SAIS 1 1 SDB
38. 4 iF AO RUHL EXMRR tRS 2 TATORRH HS BET EOS APIS EIN RORERCL RLY Miche O bE lt S ORR SL LELTRY CV ase 1 320 HHHHH 89 2015 APRIL 27 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA UDI UDr UDI MTJAPAN Vers ff 1 UDI Unique Device Id
39. 2 19 89 2015 APRIL 11 hhh 4 5
40. 28 2 A So H27 5 28 5 30 H27 11 11 11 12 MEDICA COMPAMED2015 H27 11 16 11 19 gt
41. KKR KKR 21 45 2 3 PMDA 44 67 20 30 ar 15 20 25 2013
42. JHIDA EN 2 J ami i y REBOOT pen _ 6 ne gt
43. 25 8 4 1 2
44. DPM 25 12 60 DPM UDI 5
45. L 2 oll 25 9 24 895 2015 APRIL hhh
46. 2 HHHH 89 2015 APRIL 35 5
47. 2 29 4 28 3 PMDA 4
48. 2 3 3 4 26 7 6 2 1 270 2 3 1
49. HHHHH 74 F895 2015 APRIL 8 LSSS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SSS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SLL SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS TA UA TAR het 3 11 1 25 11 45 6 17 2 49 72
50. 4 Diet CVV 1 2 3 4 3 25 11 27
51. 25 8 4 5 ee 1 3 4 14 89 2015 APRIL hhh 25 2 4 26 2 4 3
52. We a hua IS 0 65 lt 4 OEM 3 an Ia S267 it lt 4
53. 1 0 10 20 30 40 50 60 70 80 90 QMS QMS QMS QMS om LAC ae UOUUOU 895 201542 APRIL 23 Ohhh 14 PMS Ph MTJAPAN 47 7U ff 1 26 11 26
54. EP 25 16
55. 25 8 51 7 24 5 2 1
56. 1 1 GMTA 5 10 2 AdvaMed Eucomed 3 GMTA WHO NGO 2 1 2 89 2015 APRIL 51 hhh 3 4 JICA JETRO OMETA MEJ 5 JPTRO 3
57. AED 26 10 19 17 11 1 2 3 4 5 NY 89 20154
58. 3 38 1 22 3 89 2015 APRIL 69 Ahhh 1 _ Bre UR TAY BC a 2 7 4 FOSREALTESC ERS PAOMEPECSHE TST SCeP CET
59. NH 6 162 0822 3 2 8g B TEL 03 5225 6234 FAX 03 3260 9092 http www jfmda gr jp
60. 52 89 2015 APRIL hhh 2 27 2 1 2 3 2 MTJAPAN 28 4 2 29 4 28 29 28 29 3
61. 89 2015 APRIL 39 hhh Q7 9 A7 Q8 A8 Q9 2 AQ Q10 A10 lt gt Mr Dery Akmal Abdul Rahman Senior Assistant Director Registration Licensing amp Enforcement Division Ms Suhaida Rasul Senior As
62. 89 2015 APRIL 29 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA GTTIN FDA 28 9 IH FDA UDI 4 2 DPM
63. a eo a ae 2 1 130 2
64. QMS 6 Ql ro kas 0 10 20 30 40 50 60 89 201542 APRIL 19 hhh Q2 Pp ye cee eee a I al Ea ee QMS QMS m QMS amp 0 10 20 30 40 50 60 70 80 GRORBT VEULTIX QMSHIARH DU AZv RY AY hI LSE
65. 27 GE 6 4
66. 2
67. GCP PMDA DTM ss EE 26
68. 2 4 gt http www jshpm or jp about
69. 4 MDPRO 27
70. 19 AA 1 000 7
71. QMS 4 QMS QMS QMS QMS CF 16 169 QMS 2 26 94 QMS QMS
72. T960 8670 2 16 TEL 024 521 7282 E mail medical unit pref fukushima lg jp URL http www fuku semi jp iryou pj 10 89 201542 APRIL 3 lt 4 OC
73. TISO 138485 QMS 1 ISO 13485 QMS ISO TC 210 2 QMS 1 QMS QMS 54 89 2015 APRIL hhh 2 PMS Q amp A 3 PMDA ARCB QMS
74. 2 3 4
75. 2 89 2015 APRIL 3 hhh 1 26 11 13 80 5
76. TV 89 201542 APRIL 6 7 hhh 2 25 ec 1 2 3 4 5 NEDO JST NEXT ep 6 7
77. apg ea g f it ttc eee WF x sg Betiscgtsaege lt ka A 7 a Pr iat ge n 1 pi fest it ii Ean G i hy te gt ei ee ee ee ue ope Gi ee Ss5 5 at amp AK Vi yor 5 1 AF tp ieee ae SEER 3 S0ae se Sele hoe Uk eee io Pe Shee A ml gras S8 RE be Ae ga of ae a HHHHH 16 89 2015 APRIL Q 26 8 27 3 18 KKR HOTEL TOKYO 26 3
78. 1 2 1 WG5 1 89 2015 APRIL 55 hhh 2 WG 1 Q amp A 3 28 2 4 PMS MTJAPAN 7 l 26 11 25
79. PMS PMS IMV PMS PMS Ai HF fall Ze 26 895 201542 APRIL Uhhh X
80. Sy we 7 UDI NTT
81. 89 2015 APRIL 13 gt ro JS 2 gt eee HS A 1 sswws lesms s penastse eransanamnaaw oe on ae Nae 095 ye 25 2 100 91 1 83 3 94 4
82. 27 2013 1 1 1 2 2013 28 2 3 27 9 28 2 4 QMS PMS 5 6 UDI UD1 TBD 2 WG 1 WG H
83. EL 1 1 ani CO CS Ee ae NB hs i Mn Ren Aaie maues Me WT LTHT HH me TI uy 7 gucecmmencuenmnen mes WG CDT WC EAR WG
84. 1 JICA 27 2 9 2 25 IJICA JICWELS EPP JICA PMDA_ JIRA MTJAPAN 2 12
85. 1 Ma CARY Ze FAT KE 9 OO 455 CRO 40 5
86. 2025 28 27 AK RF Be HA H 8 KR BZ A A Bo FF Z FA fai OA RR B We th N BW 89 27 4 27 162 0822 3 2 8 TEL 03 5225 6234 FAX 03 3260 9092 http wwwr jfimda gr jp AAT BR FAR EN
87. 8 asl Pall 5 1 2 ATP a 3 4 AED 5 6 7 C 8 20 3 0830001 0880018 35 145 2 4
88. Q1 Q2 4 2 2 1 4 2 16 7 m1 5 a e5 77 1 22 89 2015 APRIL Ohhh 6 Q3 2 Q amp A Q amp A l l 1 in
89. 2 89 201542 APRIL hhh ESA 72 SHERRI OVYTIEROL BY CT EE 7 r EA amp DRL OSHS i MEE Voto 2
90. 3 29 4 4 MDIR 5 5 6 7
91. ATR NY 6 Ow 1
92. 56 50 Q1 Q2 12 0 1 1 5 1 HS m 5 89 2015 APRIL 21 Ohhh Q3 1 1 1 1 a i 2 _ iz i L eae q QMS 1 2
93. UDI UDI ME KARO M LER MR BRRS RROA PSEOM LICRDBOTWSIER NTT CC DPM RETD UDI 89 201542 APRIL 31 DUA hhh 3 66
94. gt lt 7 zk WH Sh 5S Yi WM GO 3 lt 4 QMS QMS QMS QMS 19 MTJAPAN BME PMS FF 24 MTJAPAN 47 7 8 UDI UD I UDI fi 28 MTJAPAN 26 33 MTJAPAN RET AF 4 DIVER 89 2015 APRI
95. ee 4 MTJAPAN 1 2 3WG 2 1 1 2 PC 1 3 WG 1 4
96. 4 UDI Sa ee HHHHH 32 895 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 26 Ah MTJAPAN 3R 7 AF 4 DIVER i ________________tt_ttt_ttt__ e 1 26 27 2 20 26
97. ISO 9001 27 89 2015 APRIL 59 hhh 1 1 2 2 1 3 AMED 4
98. rw 6 5 DIC ge ft a hes gt IDENTAPAC KOKORO HAPI HAPI
99. 2 89 2015 APRIL 5 hhh 2 2 7
100. Luss 2 8 89 2015 APRIL hhh ae Beis BEES AT A RSE TX VE 2 7 58 4
101. A OKRA field OBE 66 89 2015 APRIL Uhhh 5 1 1
102. NN er HONPARe4d
103. 1 1 2 5 56 895 2015 APRIL hhh 3 2 1 1 8 2 EMC EMC 1 2 3 4 EMC
104. 4 5 6 58 895 2015 APRIL hhh ISO TC 210 ISO JIRA ISO TC 210 1 WG 1 WG 1 QMS ISO 18485
105. 838 1 1 2 2
106. CT 2 70 89 2015 APRIL hhh 2 SE LOL we Seon ay me oer DARA ke tT 1 SE 0 8 0 Bee OH MERIT MdN PR
107. Q2 PMDA A2 Q3 UDI UDI A3 UDI Q4 ae A4 Q5 A5 JETRO JICA Q6 A6
108. sat BUEN T PLS LARD Ee Px Win 17 0 2 4 1 2 3 4 5 _
109. 28 89 2015 APRIL 7 hhh 3 27 1 1 1 4 8 4 3 4 29 7 2 ICT 1 2 3 4 1 8 5 5 3
110. 1 24 1 24 1 2 3 11 1 3
111. QMS QMS QMS QMS 23 6 4 7 QMS 26 12 11 12 7 QMS 24 3 21 22 2
112. 12 3 14 PMDA 2 PMDA PMDA 11 25 TKW Ui e ic PMS
113. 1 IMDRF 9 3 2 GMTA IMDRTF 3 4 EU 4 HBD HBD 1 HBD EAST 2015 Think Tank Meeting 9 IMDRE MTJAPAN 1CT 8 4 5 7 9 10 12 1 3 1 1 2 2
114. AMG se IMDREF UDI UD1 2 UDI UDI 26 9 FDA UDI UDI WG UD1 WG
115. JIRA 1 6 5 7 9 11 1 3 2 1 4 2 3 MEDTEC 4 MEDIX 6
116. Activities of International Policy amp gt For mutual benefits of authority industry and patients St rategy Committee GHTF recognition submission route subject to the product approval in GHTF country is set up in gt Collect information from global conferences and or Malaysia meetings and share information among member associations gt However still CSDT is required to submit in addition to GHTF approval proofs as it is regulated GMTA BOD General Assembly every May and October lt Eu omed MedTech Conference gt Thus further reduction of CSDT documents to submit AdvaMed MedTech Conference in GHTF recognition route is a next issue to pursue in Participate in activities at GMTA as the NGO authorized by Malaysia for all the stakeholders WHO gt Propose strategies of global activities 4 Q amp A Ql Al
117. 27 4 1 2 29 4 28 3 PMDA 48 A895 2015 APRIL hhh
118. 1 1 Q amp A 2 2 Q amp A 1 1 1 1 1 l 10 20 30 40 50 60 70 80 90 100 5 8 QMS 27 1 29 30 8 QMS L
119. 2015 9 7 MC 89 2015 APRIL 43 hhh ONCAR N14R4 2015 3 4 NOCAR 10 MC 11 2016 4 9 IMDRE MC 2 NCAR SaMD SaMD QMS 2015 4 5
120. 27 2 27 5 8 5 10 89 2015 APRIL 63 hhh lt I COM gt 1 25 7 7 2 1 26 5 17 lt 5 18 3 24
121. AS St ARTIC DIE IC OVC Gr UC BAW TE EBC Sc bl 38 Raton NII WW lt arn STON Ye 2 A MA 34 895 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
122. BW JIRA BEIT VARS 4 DIVER lt gt 28 C2 89 2015 APRIL 53 hhh 1 1 2
123. IMDREF 4 IMDREF 2015 9 46 89 2015 APRIL hhh gt IMDRF International Medical Device Regulators Forum 1 IMDRF IMDRF 2011 2 2011 10 EU WHO
124. 1 1 RoHS 2 RoHS 3 REACH 4 2 1 ErP EuP mplementing Measures 3 2 1 27 3 AR OKEE AIICFE 5 AHR TE ZAEMICOVYT 1 MTJAPAN
125. 2015 1 2015 3 BS ae ee oe amp RIAD EM 3 4 D _ VERICUE Rae 2015 1 2015 4
126. 2006 10 100 27 2 12 10 00 12 45 1 36 895 2015 APRIL hhh OPC ae 2
127. 25 1 12 89 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 19 6 Ver1 02 1 1 25 7
128. FDA UDI UT FDA GUDID Global UDI Database GUDID GUDID UDI 3 UDI FDA UDI IVD AMDD UDI WG WG UDI AMDD
129. QMS WG TT 89 2015 APRIL 45 hhh 2015 9 7 GMTA 2015 WHO N
130. a ge gu ye we gy Rg 89 2
131. 27 1 ILE MTJAPAN F ILE Aa KE MTJAPAN ILE MTJAPAN A LK MTJAPAN JIRA DOD in teh JIRA Ha 5 7 Se EAT MTJAPAN meIAT FAIL MTJAPAN FILER JEITA FILER MTJAPAN Ve NUR JIRA METIS HHHHH 89 2015 APRIL 61
132. 7 20 N23 MC 9 IMDRE MO ORPS ToC W RPS WG 2015 9 2016 9 Medical Device Patient Registry Registry WG 3 amp EMDEpiNet Mirror 4 TISO TS 19218 ISO TC 210 0 RS 2 GMTA RS MC 2 lt Q amp A gt IMDRF WG
133. 1 25 7 LTI EELE a ae ao Fee 3 25 22 2 75 2 8 92 6 25 1 1
134. WG JIRA JRTITA MTJAPAN CL an Loess JADIA PMS WG PMS
135. QMS PMS WG 3 PMS WG PMS 89 2015 APRIL 37 Uhhh ISO TC 210 WG JWG ISO IEC Organization of Committee
136. 19 4 370 130 Medical Device Market Investment in Malaysia World Japan 2013 ee gt TOSHIBA MEDICAL SYSTEMS New factory opens in December 2014 Penang Product Ultrasonograph etc gt Medical Device Market 30B edical Device Marke 200 Jobs 2020 gt Share of the world market 8 0 gt Annual Growth Rate 3 9 gt NIHON KOHDEN Ultrasonograph New local subsidiary opens in 2014 Kuala Lumpur 4 Jobs gt TERUMO Local subsidiary opened in 2012 Subang Selangor Darul Ehsan 19 Jobs Espicom Worldwide Medical Market Forecasts to 2018 3 PMS WG
137. UDI MEDIS DC 30 895 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 6 DB IMEDIS DC
138. 19 15 8 1 1 2 27 3 27 4 5 2 1 2 26 4 3 4 5 27 HHHHH 89 201542 APRIL 27
139. GVP PMDA Q amp A PMDA PMDA BEAU BESS BOF PMDA PMDA lyCWicie as bic PMDA
140. QMS ISO 13485 Our 2014 GMDN OZ 2 FDA IT UDI PMS LDT 120 3 WG MDSAP 2018 11 6 N3 N4 N5 N6 N11 N22 2 PD1 N8R2 PD N24R2
141. 4 ty 1 2 6 89 2015 APRIL 65 hhh X
142. CMDCAS MDSAP 4 MDSAP WG MDSAP 2016 6 SaMD SaMD
143. FDA UDI UDI 7 GS1 UDI UDI
144. ISO TR 14969 SO13485 2 WG2 ISO 16142 2 3 WG3 IEC SC 62 AMT25 ISO TS 19218 1 4 WG5 ISO 18250 5 WG6 PMS PMS 6 JWG 1 Risk Management ISO Guide51 ISO Guide638 TISO 14971 7 JWG 2 Software IEC 62304 am1 1IEC 62304 2 IRC 82304 1 TC215 JEITA 8 JWG 3 Usability IEC62866 1 2 TEC62366 2 9 JWG 4 ISO 80369 1 ISO 80369 7 2 ISO TC210 2015 11 ISO TC 210 eo ISO 13485
145. QMS OMS QMS EY MTJAPAN 4 7 1 fh 8 1 26 QMS 3 28 QMS 7 QMS 8 QMS 2 28 QMS 26 11 7 18 28 ei QMS 2 000 26 i 1 578 889 2 476
146. WQ 1 5 WQ 1 50 89 2015 APRIL hhh 6 WG 1 26 1 879
147. solution 2 3 AP 4 QMS PMS QMS JIRA 26 11 25
148. 1 2 3 1 1 WG WC
149. S Ae ie 2014 9 MC HUUUD 89 2015 APRIL 47 6 27 eo 27 27 4 1 88 3 81 26 11 25 6
150. 11 25 IKW IKW PMDA _ SGML 9 SAR sses mm TTF ve Sg hee ae eer Erna Sara LY A oe Batre bd eo a SHE ALE PRK LWA AN SSF EoReR PMDA eos EE Ze BAT ecm ee 89 2015 APRIL 25 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA PMS PMS WG
151. 2 3 EU OEU TVD 2014 EC 2014 6 MDSAP 2014 11 25
152. 3 QMS MTJAPAN ETAT 4 DIVER 1 1 WG1 1 2 5 2012 WG2 1 HBD 3 WG3 1 4 WG4 1 5
153. BW MTJAPAN Vx rsvilf FDA UDI UDI UDI 1 UDI UDI 1 FDA UDI 2015 9 2016 9 L 1 UDI 2 FDA UD1I 2 EU 2 UDI 1 3 UDI 1 2 UDI
154. Stakeholder Forum 1 2015 IMDRF 8 24 3 26 3 24 3 26 3 25 Stakeholder Forum 170 Aa Clit OMBSRERKLET GE IMDRE 2 Stakeholder Forum H 2015 3 25 9 00 17 15 1 IMDRFRE HEE IMDRF PMDA 7 IMDRF MC 3 MC
155. The Japan Federation of Medical Devices Associations AAR Riese Eas 2 7 25 4 370 2 140 2 230 12 19 te Binete S 715810 The Japan Federation of edical Devices Associations G Rie coe 162 0822 3 2 8FB URL http www jfmda gr jp E mail info 1 jfmda gr jp TEL 03 5225 6234 FAX 03 3260 9092 Contents 1 27 i ia 1 HI 2
156. 19 ao l 2 3 HHHHH 2 89 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Vv HH Summary of The Pharmaceuticals and Medical Devices and Other Therapeutic Products Act BES I II CCT 25 6 14
157. 1 2015 27 11 11 11 12 4 26 218 9 506 2 NRW 25 RIT 26 9 NRW NRW 26 3 MEDICA COMPAMED NRW MRDICA C
158. 23 45 KKR 8 11 20 83 44 26 35 16 21
159. 5 EMC 3 3 1 AW JETITA 771 eth 27 1 1 2
160. 40 6 43 5 42 1 41 8 37 8 39 2 27 9 23 1 20 5 26 1 26 5 25 0 20 24 28 32 36 39 OE a 23 ma om or gd 25 8 16 89 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 2 II 26 11 5 1 63 2 1
161. 1 2 3 MDPRO 1 WC 4 WG 1 1CT WG ICT 2 WG 1 1 1
162. UDI 2013 12 UD1 FDA UDI IMDRE UDI UDI 3 MDSAP Medical Device Single Audit Program 2013 12 4 RS Recognized Standards MC 2014 11 5 RPS Regulated Product Submission 2014 8 6 SaMD Software as a Medical Device 2014 9 QMS 7 Medical Device Patient Registry
163. 2 MC OA A WEB OF GMP ANVISA 42 89 2015 APRIL hhh 5 10 Oe QMS 2016 9 1 2014 6 1
164. 094807A UDI UDI 1 DPM Direct Part Marking 28 895 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 2 Vit O 2BsB 1 UD1 FDA UDI UDI UDI
165. cs 1 2 3 8 1 1 mm
166. 2012 GHTF Global Harmonization Task Force IMDREF 2 2011 2 2011 10 2012 8 1 2012 9 2 2018 3 3 201347115 4 2014 8 5 2014 9 6 2015 3 7 2015 9 8 3 OMC Management Committee RU 2015 1 WHO APE AHWP PAHO OWG 1 NCAR National Competent Authority Report 2 UDI Unique Device Identifiers
167. 5 1 IHFAX 2 4 1 4 7 10 3 4 aie BRS CELI 10 5 NY 60 895 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
168. 2 JIRA MT JAPAN lt JQA gt 2 17 ME CE 2 18 2 19 1 Wh AL gt gt CN TWins 2 20 JICWELS PMDA JICWELS sae 1 1 AK WHE SpE 2 23 2 24 2 25 2 26 pete jefe e e te os HHHHH 89 201542 APRIL 41 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA IMDRF 2015
169. 3 QMS QMS 1 QMS ISO 18485 2 1 2 4 QMS 1 IMDRE MDSAP SaMD QMS WG 2 AHWP WG QMS
170. OK 2 3 1 Fre 2012 10 BEPP Economic Partnership Program Bet
171. 2 1 2 3 4 64 89 2015 APRIL h
172. 0 1 28 29 4 1 1 2 2 28 2 4 3
173. 015 APRIL 33 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA PMDA Q amp A te Oa Ca PMDA
174. 2 APRIL 1 hhh 6 7 BEG ABER HARK EOE SAAT 8 9 10 11 6
175. 485 Proposal for QMS ordinance SO 13485 ISO 14969 Guidance for voluntary recall WG2 General aspects stemming from the application of Education of QMS quality principles to medical devices Seminars for industries and experts WG3 Symbols and nomenclature for medical devices Participation in IMDRF WG1 Application of quality systems to medical devices IFMDA QMS ISO TC 210 38 89 201542 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA 4 WG GMTA IMDREF WHO HBD WG
176. GO IMDRF ODITTA 2015 WHO NGO IMDRF WHO APEC AHWP Asian Harmonization Working Party PAHO Pan American Health Organization 8 IMDRE PMDA 3 GHTEF GHTTF
177. L 5 J I CA OR IMDRF 2015 Stakeholder Forum 6 27 7 8 9 26 3 FARR iti HESS up hp 89 2015 APRIL 36 42 48 62 69 5 77 27
178. OMPAMED 26 7 NRW 89 2015 APRIL 9 hhh NRW 9 B4 YA ERE LY RAE BE BIN O ARO FESR BR JB SHEIK 3 5 1 28 Hc j 3 Erb
179. Overview PMS Committee MD Regulation Tusk Force Tripartite Meeting Global Industry Associations AdvaMed EBC AHWP PAHO and etc Government Registered Certification Body Industry Meeting chaired by QMS WG MHLW PMDA JFMDA MHLW Pharmaceuticals amp Ministry of Health Medical Device Agency ast _ a Labour and Welware rn Committee pprova Certification Publicity Individual WG AE Event Fuguai Subcommittee Subcommittee Subcommittee UD Ge Ne Terminology WG Software WG Package Insert WG PMS WG In egula Clinical Research we 2egular peration Regulatory System Committee Three Key Posts Purpose amp Goal of PMS Committee PMS Committee works on post marketing safety vigilance aspects 1 To represent entire industrial message request Clinical Evaluation _ Retail and Maintenance 2 To communicate Japan Government 3 To conduct information sharing with membership companies PMS QMS Committee ISO TC 210 Committee of Japan TC 210 Quality management and corresponding general MHLW PMDA JFMDA ARCB ISO TC 210 WG1 aspects for medical devices METI MHLW PMDA JFMDA JACRI Improve QMS level and solve problems of aes Registered Certification Bodies Academia compliance with PAL Deliberation of ISO 13
180. S FE 18 895 2015 APRIL nee WATE A 9 BERNE META LENS UEITA A ED MIA amp CT MTJAPAN PTCA
181. TA 27 11 2 WG 27 7 3 WG 27 10 4 WG TBD 2 1 27 10 2 28 27 8 3 4 Biodesignm 89 201542 APRIL 49 hhh 5 6 3 1
182. entification FDA UDI 26 9 IMDRE International Medical Device Regulators Forum 25 12 UDI UDI UDI CC CT UD1I UDI
183. gt 26 RPP 10 00 12 30 14 00 16 30 WHE AKA ICA Z az 208 Sle JICWELS 2 9 MM PMDA 2 10 2 11 2 2 BERBER pete 2 13 GMP 2148 2 16 1
184. hh 5 FCS SRW 6 3 1 2 3 2 4 5 4 1 NHK 9 AA 16 11 25 2
185. sistant Director Registration Licensing amp Enforcement Division Ms Norhafizah Mohd Salleh Senior Assistant Director Registration Licensing amp Enforcement Division Ms Noormaslinda Abd Salam Engineer Establishment Licensing Mr Syahmi Sapit Senior Assistant Director Registration Licensing amp Enforcement Division 40 89 2015 APRIL AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA lt BR AE
Download Pdf Manuals
Related Search