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 2 3 2 QMS Audit:QMS mdsap 2014 2016 Pilot : (CMDCAS) 7 2017 : 2017 12 BSI Group America Inc. 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.

3 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) GXP QMS QMS mdsap Pilot QMS mdsap QMS 13 142015 6 23 QMS mdsap 15 mdsap mdsap mdsap mdsap .

4 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.

5 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

6 Stage1 Stage2 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.

7 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.]

8 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.

9 2015 Medical Device Regulatory Audit Reports43 ( mdsap AU F0019) GHTF/SG3/N19:2012 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 ( )

10 mdsap mdsap QMS 65 68 69 ~72 3 ( ) mdsap mdsap 50 Audit Model,Companion Document mdsap QMS QMS 1. mdsap 2. mdsap 3. 51 mdsap mdsap mdsap mdsap 27 MDSA