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 MDSAP Pilot PMDA QMS 12 2015 27 6 26 PMDA 1)

3 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. Single audit 3. MDSAP MDSAP MDSAP OK!1. 2/5. / 191. 3. / 4. / 7. 6. 1202.

4 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 20 MDSAP MDSAP / MDSAP 2930 MDSAP MDSAP MDSAP MDSAP MDSAP

5 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. 3. 5. 6. 2. 4. 2. 7. FDA Quality System Inspection Technic (QSIT) 37 38.

6 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. 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.

7 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.

8 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 MDSAP PMDA QMS MDSAP QMS 28 6 22 31 3 31 MDSAP 2/2 53 PMDA

9 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