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要 約
FDA Medical Device Guidance(旧:Guides #68)
FDA Medical Device Guidance #11
医療機器製造業者の査察
Inspection of Medical Device Manufacturers, Compliance Program Guidance Manual, Program No.7382.845

Compliance Program Guidance Manual
Program No.7382.845
医療機器製造業者の査察
Inspection of Medical Device Manufacturers
Food and Drug Administration
Center for Devices and Radiological Health(CDRH)*
発行日[Date of issuance]: February 2, 2011
Implementation date: February 2, 2011
Completion Date: February 2, 2015
Product Code: 73-91 Product/Assignment Code (PAC):
82845A, 42845A - - All Level 1 (Abbreviated) Inspections
82845B, 42845B - - All Level 2 (Comprehensive)Inspections
82845C, 42845C - - All Level 3 (Compliance Follow-up)
Inspections
82845G - - All for Cause Inspections
82845H - -Risk Based Work Plan Inspection
82845P - - Joint FDA/Accredited Person Inspections
82845S - - Report Time spent on Assessment of Firm’s
Sterilization Process
81010 - - Report Time spent on MDR Follow-up
81011 - - Report Time spent on Assessment of Firm’s
MDR Practices
81845T - - Report Time spent on Assessment of Firm’s
Tracking Practices
81845R - - Report Time spent on Assessment of Firm’s
Corrections and Removals Practices
82A800 - - Independent Accredited Person Inspections

目次 [コンプライアンス・プログラム7382.845索引]
表書き[Cover sheet]
現場報告に関する要求事項[Field Reporting Requirements]
Part Ⅰ 背景[Background]
 A.品質システム規則[The QS: Quality System Regulation]
 B.医療機器報告規則[The MDR: Medical Device Reporting Regulation]
 C.医療機器追跡規則[The Medical Device Tracking Regulation]
 D.修正、および除去規則[The Corrections and Removals Regulation]
 E.登録、およびリスティング規則[The Registration and Listing Regulation]
Part Ⅱ 実施[Implementation]
 A.目的[Objectives]
 B.プログラム・マネージメントの指示[Program Management Instructions]
Part Ⅲ 査察[Inspectional]
 A.運営[Operations]
  1.査察戦略[Inspectional Strategy]
   a.品質システム査察[QS Inspection]
   b.レベル1査察[Level 1 Inspections]
   c.レベル2査察[Level 2 Inspections]
   d.レベル3査察[Level 3 Inspections]
   e.何らかの理由による査察[For Cause Inspections]
   f.リスクベース魚む計画査察[Risk Based Work Plan Inspection]
   g.国外査察[Foreign Inspections] 
  2.査察の指示[Inspectional Instructions]
  3.設計管理に関する特別の指示[Special Instructions concerning Design Control]
  4.滅菌プロセスに関する特別の指示[Special Instructions for Sterilization Process]
  5.放射線等の発散医療機器の査察[Inspection of Radiation Emitting Devices]
  6.サンプルの収去[Sample Collection]
 B.追加的考察[Additional Considerations]
  1.登録、およびリスティング[Registration and Listing]
  2.輸入[Imports]
  3.輸出[Exports]
  4.電子的記録、および電子署名[Electronic Records and Electronic Signatures]
 C.再上市医療機器[Remarketed Device]
 D.報告[Reporting]
Part Ⅳ 分析[Analytical]
 A.分析試験ラボ[Analyzing Laboratories]
 B.実施されるべき分析[Analyses to be Conducted]
 C.方法論 [Methodology]
Part Ⅴ 法的/行政的フォローアップ[Regulatory/Administrative Follow-up]
 A.品質システムの法的/行政的フォローアップ[Quality System/ Regulatory/Administrative Follow-up]
  1.遵法的判断[Compliance Decision]
  2.委託滅菌業者、委託医療機器製造業者、医療機器最終製品製造業者 - 法的措置に伴う責任の判断[Contract Sterilizers, Contract Device Manufacturers, and Finished Devices Manufacturers – Deciding Responsibility when taking Regulatory Action]
  3.政府当局に販売された違反医療機器[Violate Devices sold to Government Agencies]
  4.行政的アクション、および法的アクション[Administrative and Judicial Actions]
  5.法的推奨事項を容易にする吟味[Facilitating Review of Regulatory Recommendations]
 B.MDRの法的/行政的フォローアップ[MDR Regulatory/Administrative Follow-up]
 C.追跡の法的/行政的フォローアップ[Tracking Regulatory/Administrative Follow-up]
 D.修正、および除去の法的/行政的フォローアップ[Corrections and Removals Regulatory/Administrative Follow-up]
 E.登録、およびリスティングの法的/行政的フォローアップ[Registration and Listing Regulatory/Administrative Follow-up]
 F.放射線等の発散医療機器の法的/行政的フォローアップ[Radiation Emitting Device Regulatory/Administrative Follow-up]
 G.輸出の法的/行政的フォローアップ[Exports Regulatory/Administrative Follow-up]
Part Ⅵ 参考資料、およびプログラムへのコンタクト[References and Program Contacts]
付属資料[Attachment]
Attachment A. CDRH、Office of Compliance組織図[CDRH Office of Compliance Organizational Chart]
Attachment B. CDRH、Office of In Vitro Diagnostic Devices組織図 [CDRH Office of In Vitro Diagnostic Devices Organizational Chart]
Attachment C. MDR報告要求事項要約[Summary of MDR Reporting Requirements]
Attachment D. 追跡要求事項要約[Summary of Tracking Requirements]
Attachment E. 修正、および除去要求事項要約[Summary of Corrections and Removals Requirements]



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