MDSAPの概要について - pmda.go.jp

1 MDSAP 12 MDSAP MDSAP MDSAP MDSAP Medical Device Single Audit ProgramMDSAP 3( MDSAP MDSAP QMS MDSAP MDSAP QMS MDSAP 4 MDSAP QMS QMS QMS MRA ISO13485 IAF QMS QMS QMS QMS QMS QMS MDSAP = Medical Device Single Audit Program BSI America Manufacturer QMS MDSAP 2 QMS QMS QMS TUV SUD AmericaLNE/G-MED QMS MDSAP EU QMS 5 MDSAP EU WHO6 Subject Matter Expert GroupRAC 6 Regulatory Authority Council(RAC) 2 3 2 QMS Audit:QMS MDSAP 2014 2016 Pilot : (CMDCAS) 7 2017 : 2017 12 BSI Group America Inc.)

2 DEKRA Certification DQS MedizinprodukteGmbH Intertek Testing Services NA Inc. LNE G-MED SAI Global Certification Services Pty Ltd. SGS United Kingdom Ltd. TUV Rheinlandof North America, Inc. T V S D America Inc. T V USA, Inc. UL Medical and RegulatoryServices UL, LLC Lloyd s Register Quality Assurance Inc. National Standards Authority of Ireland NSF Health Sciences Certification, LLC8 MDSAP MDSAP MDSAP MDSAP MDSAP 2012 11 MDSAP 2013 MDSAP 2013 10 2014 1 2016 Pilot 2015 1 2015 3 2015 6 2017 1 27 4 13 3 AMDD EBC MDSAP 10 RSI 27 6 26 11 ( 27 6 26 MDSAP Pilot QMS IMDRF IMDRF IMDRF IMDRF)

3 MDSAP Pilot pmda QMS 12 2015 27 6 26 pmda 1) GXP QMS QMS MDSAP Pilot QMS MDSAP QMS 13 142015 6 23 QMS MDSAP 15 MDSAP MDSAP MDSAP MDSAP : MDSAP QMS 2017 2018 2019 Transition Plan for the Medical Device Single Audit Program (MDSAP) III IV ANVISA GMP Certificate ANVISA MDSAP GMP Certificate MDSAP MDSAP 16 MDSAP 2.

4 Single audit 3. MDSAP MDSAP MDSAP OK!1. 2/5. / 191. 3. / 4. / 7. 6. 1202. 3. 1. 2215. 6. pmda !4. ISO 222015201620172018201920209259125 ISO 9001:2015 ISO 13485:2016 MDSAP EU MDR EU 23 MDSAP MDSAP MDSAP MDSAP ISO/IEC 17021-1:2015 IMDRF/MDSAP WG/N3 IMDRF/MDSAP WG/N424 IMDRF MDSAP WG IMDRF MDSAP/ N3 IMDRF MDSAP/ N4 QMS IMDRF MDSAP/ N6 QMS IMDRF MDSAP/ N5 IMDRF MDSAP/ 11 25 1 12 24 3 3 1 2 27 2 2 2 1 Program Manager Upload Stage1 Stage2

5 20 MDSAP MDSAP / MDSAP 2930 MDSAP MDSAP MDSAP MDSAP MDSAP Audit Model & Companion Document MDSAP MDSAP Audit Report Policy MDSAP GHTF SG3/N19 QMS QMS ISO 13485 RESOLUTION -RDC 21 CFR Part 820 QMS 4 68 MDSAP QMS ISO 17021 GHTF QMS 32 1 12 23 Stage 1 Stage 2 34 MDSAP 35 MDSAP MDSAP QMS 36 MDSAP 1.

6 3. 5. 6. 2. 4. 2. 7. FDA Quality System Inspection Technic (QSIT) 37 38 ..1. 2.. 10..1. (TGA): ANVISA) 8. 2 1 [ISO 13485:2016: , , , ; TG(MD)R Sch3 P1 (4); RDC ANVISA 16/2013: ; MHLW MO169: 5, 6, 8, 9,; 21 CFR , ] TGA TG(MD)R Sch3 P1 5 ANVISA RDC ANVISA 16/2013: RDC ANVISA 16/2013: RDC ANVISA 16/2013: QMS 1.

7 3. 5. 6. 4. 2. 7. CAPA 40 41 A B1 AM 1 PM 2 AM 2 PM 3 AM 3 PM MDSAP MDSAP 42 GHTF/SG4/N33R16:2007 26 10 24 1130002 QMS GD211 Guidance on the Content of Quality Management System audit reportsMDSAP AU MDSAP Medical Device Regulatory Audit ReportsIMDRF/MDSAP WG/N24 FINAL: 2015 Medical Device Regulatory Audit Reports43 (MDSAP AU F0019) GHTF/SG3/N19.

8 2012 44 26 10 24 1130002 QMS 1 2 QMS 1 / +1point)2 +1point) 45D0 D0+5 a) 5 ,b) 4 2 ,c) ,d) ,e) D0+15 D0+30 4 5 D0+45 5 D0+90 46 MDSAP MDSAP MDSAP MDSAP 27 MDSAP 27 11 Audit Model & Companion Document) 28 MDSAP 47 MDSAP QMS 65 68 69 ~72 3 ( )MDSAP MDSAP QMS 65 68 69 ~72 3 ( )MDSAP MDSAP 50 Audit Model,Companion Document MDSAP QMS QMS 1.

9 MDSAP 2. MDSAP 3. 51 MDSAP MDSAP MDSAP MDSAP 27 MDSAP MDSAP MDSAP 1/2 52 28 6 22 0622 3 0622 1 MDSAP Pilot 28 6 22 0622004 MDSAP Pilot 28 12 27 1227 3 1227 3 MDSAP Pilot MDSAP 28 12 27 1227003 MDSAP Pilot MDSAP 30 3 29 0329 10 0329 1 MDSAP Pilot MDSAP 30 3 29 0329002 MDSAP Pilot MDSAP

10 MDSAP pmda QMS MDSAP QMS 28 6 22 31 3 31 MDSAP 2/2 53 pmda MDSAP MDSAP QMS TEL : 03-3506-9446 FAX 03-3506-9465E-mail: 54 55 27 6 MDSAP MDSAP 28 6 12 30 3 31 3 MDSAP MDSAP QMS MDSAP FDAMDSAP : MDSAP : MDSAP Q&A: IMDRFMDSAP #imdrf pmda (English)56 MDSAP