MDSAPとは

MDSAPとは


Medical Device Single Audit Programの略。
オーストラリア、ブラジル、カナダ、日本、アメリカの5か国の規制当局の規制要求事項に対する製造業者のQMSの適合性および妥当性を、認定された調査機関による1度の調査で確認するプログラム。

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAPの経緯
  • 2012年：IMDRF初開催会議にて、MDSAP議論開始
  • 2014年1月1日：MDSAP Pilot Program開始（3年間）
  • 2017年1月1日：完全実施へ移行
MDSAPの特徴
  • MDSAP参加国がQMS調査機関（MDSAP調査機関：MDSAP Auditing Organizations（AO））を共同で評価・認定し、その質を一定程度に担保するとともに、MDSAP調査機関が実施したQMS調査結果（MDSAP調査報告書）の各国での活用を目指す。
  • MDSAP参加国が協力してQMS調査機関の認定・監督を行う。 参加国のうちの複数国の監督者（規制当局）がQMS調査機関への監督業務（立入調査）を実施する。
  • QMS調査機関がQMS調査を実施する際に、複数国のQMS要件をカバーした調査を一度に実施する。
MDSAPの概要

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAPによるメリット
  • 頻回のQMS調査を回避できる。
  • 複数の行政や認証機関による審査を年に何回も受審すると、それぞれに異なった審査手法や指摘事項に戸惑うこともあるが、そのようなことは回避できる。
  • CEおよびISO 13485 の審査と組み合わせて実施することができる。
  • 年１回の定期的なMDSAP審査は、事前に日程と計画等の調整が行われるので、 「計画的に審査を受けるための準備」が行える。
  • 複数の審査が1回で行われるため、準備のための工数削減ができる。
  • 日本語で審査を受けることも可能となる。（調査機関による）
  • ブラジルでは現在1,000社を超える企業がANVISAによる査察を待っており、査察までの期間は平均して3年に達している。ブラジルの規制当局からの要件をMDSAPを通じて満たすことによりブラジル市場への製品投入が早まる。
  • FDAの定期的査察を置き換えとなるため、工場の操業やスタッフの業務中断を最小限に抑えることができる。。
MDSAPによるデメリット）
  • 一度の監査で世界の市場を一度に失う危険性がある。
  • FDAのFor Cause査察のトリガーとなる可能性がある。（当局査察を誘引する）
  • 日本の法規制においては、新製品の承認・認証の申請がなければQMS適合性調査は5年に１回であるのに対し、MDSAPの審査は年１回必ず実施される。MDSAPの審査機関とは継続的な関係を持つことになる。
  • １回あたりの審査期間（人・日）は、会社規模にもよるが、概して実地でのQMS適合性調査よりも長い。

各国の動向

日本
  • 日本は現在、MDSAP調査結果の試行的受入期間中
    • 試行期間：平成28年6月22日～平成31年3月31日
  • 日本は（カナダのように）MDSAPへの全面的な移行を考えている訳ではない。MDSAP報告書を提出するのは、ひとつの選択肢であり、その選択肢が増えたと考えるのが妥当。従来どおりのQMS適合性調査を選択することも可能。
  • MDSAP調査報告書の受入れに関する基本的方針：
    • PMDAが実施するQMS適合性調査において、MDSAPにおける調査報告書を試行的に受け入れ、実地調査から書面調査への切り替え、書面調査時の提出資料の削減等の調査手続きを合理化する。
    • 上記に際し、QMS適合性調査手数料は通常の手数料を適用する。
      （少なくとも試行期間中は、手数料は変更しない。）
  • PMDAがMDSAP報告書を受け入れるため、医療機器のクラスに関わらず、承認時及び定期適合性調査において、実地でのQMS適合性調査は回避できるようになる。
  • 登録認証機関もPMDAに倣ってMDSAP報告書を受け入れるので、認証品についても同様に、実地でのQMS適合性調査は回避できる。
  • PMDAは、MDSAP利用申請を受け付けた場合、当該申請にかかる全調査対象施設のうち、MDSAP報告書を利用する施設に対する調査については、以下の事例を除き、原則として書面による調査を行うものとする。 ただし、法の遵守状況、管理状況等を勘案し、必要と判断した場合には実地調査を行うことがある。
    1. 細胞組織医療機器を製造する登録製造所
    2. 放射性体外診断用医薬品を製造する登録製造所 　
    3. 製造販売業者
  • 日本ではQMS省令第2章のみの適合性調査報告書の代替として、MDSAP認証書を受理。
  • そのため上記事業所はMDSAPによる調査の合理化対象からは除外される。


画像出典：「MDSAPの調査結果の 試行的受入れについて」（PMDA 登録認証機関監督課 資料）

アメリカにおけるMDSAPの利用）
  • FDAはMDSAP調査報告書を定期査察の代用として使用する。
  • 以下の査察にはMDSAP調査報告書は利用しない：
    • For Cause査察
    • コンプライアンスフォローアップ査察
      • 前回OAIとなった査察の改善状況確認査察
    • 市販前/市販後承認査察
    • 電子製品放射線規制に対するコンプライアンス調査
カナダにおけるMDSAPの利用
  • 製造業者のQMS要求事項への適合確認の手段として、規制に取り入れる。
  • 2017年、2018年を移行期間として、 2019年1月1日以降、これまでのCMDCASからMDSAPに完全移行する。
  • カナダでは、2019年よりMDSAPの認証のみの受け入れる。
    • カナダで医療機器を販売する企業の場合、MDSAPを必ず受審・認証を受けなければならない。
  • 製造業者は有効なMDSAP認証書を2018年12月31日までに提出しなければならない。
  • ただし、製造業者が12/31までにMDSAP認証書の提出がない場合でも、当該製造業者がMDSAPをすでに受けていることを証明したならば、 Health Canada（ HC：カナダ保健省）は法的措置は講じない。
    • 製造業者のMDSAP移行のためのスケジュールがタイトであるという業界からの意見を受け、コンプライアンス期限を緩和。
オーストラリアにおけるMDSAPの利用
  • 製造業者がオーストラリア適合性評価手続きへの適合を証明することを監査する際に、MDSAP監査報告書を考慮する。
ブラジルにおけるMDSAPの利用
  • ANVISAは、特定のリスクの高い機器の場合を除き、初回の審査でMDSAPを受入れている。
  • クラスⅢ・Ⅳ機器の製造業者に対するANVISAのGMP Certificateの発行に際してANVISAの査察に換えて、MDSAP報告書を利用。
  • ただし、前回のANVISA査察の結果が不十分と判断された場合、MDSAP監査報告書は使用されない。
EUのMDSAPへの見解
  • 28か国での合意へ持ち込むことが困難であるため、今のところEUがMDSAPに完全参加する可能性は低い
  • EUは現在MDR（Medical Device Regulations） / IVDR（In Vitro Diagnostic Regulation）の実施に注力しているため、MDSAPに割ける余裕がない。

MDSAPに対応するにあたって

MDSAPで留意すべき点
  • MDSAPは一度の調査で5か国の規制要件への適合性が調査される。
  • すなわち、5か国共通の要求事項に対する重大な不備が発見された場合、調査機関から5か国に対し当該不適合が報告されてしまう。
    • 場合によってはFDAからWarning Letterが送られてくる、当局によるfor cause査察が行われる等の可能性がある
  • また、初年度にグレード4、5に等級付けされた不適合を次回監査までに是正できていない場合、加点ルールに従ってさらに高い不適合グレードを付与されてしまう。
  • つまり、1年目はかろうじて監査をクリアしたとしても、次回調査で当局報告レベルに達する不適合判定を得てしまう可能性がある。
MDSAPに対応するにあたって
  • MDSAPはCompanion Documentをベースにプロセスリンケージに着目した調査が行われる。
    • companion Document：13485:2016をベースにし各国の要求事項を追加したMDSAP調査手順書
  • Companion DocumentはISO13485の箇条をそのまま記載するのではなく、各要求事項の遵守により達成されるべき状態に製造業者のQMSがあることを確認することを求めている。
  • すなわち、ISO13485等の要求事項の本質を製造業者が理解し、自社のQMSに落とし込んでいるかが調査される。 さらに、プロセスリンケージに沿った調査が行われるため、QMS内のプロセスのつながりを適切に理解しないことには、調査にタイムリーかつ適切に対応することは難しい。
  • MDSAP受審前に、規制要求事項の本質の理解および自社のQMSの理解、自社QMSの不備事項の事前の発見、改善が肝心である。

MDSAP審査プロセス

MDSAP調査に関わる主体の関係性

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAP Audit Modelとは
  • MDSAPの監査シーケンス、手法のこと
  • MDSAPの監査シーケンス
    • ロジカル・集中的かつ効果的な監査が行われるようデザイン・構築されている。
    • プロセスアプローチを採用（5つの主要プロセス＋2つのサポートプロセス）
      • 5つの主要プロセス
        • 1.マネジメント
        • 2.測定・分析・改善、
        • 3.設計開発
        • 4.製造およびサービスの管理
        • 5．購買管理
      • 2つのサポートプロセス
        • 1.製品販売許可＆施設登録、
        • 2.医療機器有害事象＆不具合等報告
  • MDSAP監査手法
    • プロセス間のリンケージを意識した監査の実施
    • 組織のQMSに組み込まれたリスクマネジメントの評価
Companion Documentとは
  • 医療機器製造業者が規制要求事項を満たしていることを確認するための、調査機関による監査手法が示されている文書。
  • ISO13485の要求事項をベースに、MDSAP参加国の独自の要求事項が記載されている。
MDSAP調査基準
  • 加盟国のQMS関連要求事項を、一回の調査で一度に確認し、調査負担を軽減することを意図している。
  • 適合性調査の際にはMDSAP Companion Document（MDSAP AU G0002.1.004）が用いられる

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

製造業者に対する調査サイクル
  • MDSAP審査は3年サイクルで行われる。
  • 初年度：
    • Stage1 調査：文書および準備状況全般の審査 通常、計画中の文書の審査が含まる。
    • Stage2 調査： ISO 13485、ならびにMDSAPに参加している規制当局のその他の要件に基づくQMSコンプライアンスの評価
  • サーベイランス調査：製造業者の製品またはQMSプロセス内の初回調査以降の変更点を評価するために毎年実施。
  • 更新調査：MDSAPの下でQMS要件を満たす上で製造業者のQMSの適性および効果が継続していたかどうかを評価するために3年目に実施。
製造業者に対する調査サイクル

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAP調査プロセス
  • MDSAP調査は７つの調査プロセスから構成される。
  • FDAのQuality System Inspection Technic （QSIT）に準じるアプローチで調査が進められる。
    • プロセスのリンクが重視される。
  • 監査工数は、適用される調査タスク数により算出される。
  • 各プロセスの調査に際しては、オーディットモデルとコンパニオンドキュメント （MDSAPにおける調査手順書）に記載された調査タスクに沿って、調査が進められる。
  • 調査タスクはQMSの一般要求事項に基づいた調査タスクと、各国固有の要求事項に基づいた調査タスクから構成される。
  • 輸出していない国の固有の要求事項に関連した調査タスクについては、適用されない。
MDSAP監査モジュール
プロセスリンケージ

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAP調査プロセス順序とタスク数
MDSAP調査工数算出シート
プロセスリンケージ例1
MDSAP Companion Document　CH.3 測定、分析及び改善

タスク2：顧客の苦情、フィードバック、サービス記録、返却された製品、内部監査及び外部監査の所見、規制当局の監査及び査察で見つかった不適合、並びに製品、プロセス、不適合製品及び供給者の監視によるデータを含め、測定、分析及び改善プロセスヘのインプットのための品質データの適切な情報源が特定されているかどうかを判断する。

これらの情報源によるデータが正確であり、（適切な場合）有効な統計的手法の使用に関する文書化された手順に従って分析され、是正又は予防処置を必要とする可能性のある既存及び潜在的な製品及びQMSの不適合が特定されていることを確認する。

  • リンク：購買
    • 測定、分析及び改善プロセスの監査中に、完成機器に関する苦情を含め、製品の不適合に関するデータを監査チームが見つけ、当該の品質問題の根本原因が供給された製品まで遡る場合がある。 購買プロセスの監査中、監査チームは、供給された構成部品又はプロセスの不適合の是正処置指標を有する監査対象の供給者の選択を検討することが望ましい。

苦情調査の結果から供給者に対する是正要求（SCAR）、供給者管理にまで調査が及ぶ可能性がある。

プロセスリンケージ例2
MDSAP Companion Document　CH. 5 設計・開発

タスク16：設計が適切に製造に移管されたかどうかを確認する。

  • 適合性の確認：設計の製造への移管
    • このフェーズ中に、設計は製造の仕様に転換される。 これは段階又はフェーズを踏んで行うことができる。 監査チームは、選択したプロジェクトの設計がどのように製造の仕様に移管されたかをレビューするべきである。 必須のアウトプット及びリスクマネジメント活動の組織による特定に基づき、製造プロセスの重要な要素（供給者から提供される製品及び確立されたプロセスの許容度を含む）をレビューし、それらを設計記録に含まれる承認された設計アウトプットと比較する。 これらの活動で、設計が適切に移管されたかどうかを確認することができる。
  • リンク：生産及びサービス管理、購買
    • （必要とされる場合は）プロセスバリデーションを含め、機器の生産プロセスが定義され、文書化され、実行されていることを検証する。 生産プロセスによって導入される、又は悪化するおそれのある潜在的ハザードが特定され、生産管理が確立されていることを確認する。 生産プロセスには、製造指図が含まれるだけでなく、受入れ活動のタイプ及び範囲、装置の校正及び保守の間隔、環境管理、及び要員管理などの内部管理も含まれる。
    • 製造業者が、供給される製品及びサービスと製品リスクとの関係に基づいて供給者の管理のタイプ及び範囲を決定していることを確認する。

設計移管活動審査中に生産及びサービスの管理、購買プロセスの審査が行われる可能性がある。

不備事項の等級付け

不備事項の等級付け
  • 以下の基準に基づいて不備事項が等級付けされる
    • 当該不備がQMSに与える影響
      • 間接： 13485 4.1項～6項／直接：13485 6.4項～8.5項
    • 当該不備が初回か再発か
    • 加点ルール
      • 文書化されたプロセス/手順の欠如（+1point）
      • 不適合製品の出荷（+1point）

画像出典：「MDSAPの概要について」（ PMDA 登録認証機関監督課 資料）

MDSAP調査後のタイムライン


MDSAP適合性チェックリスト


イーコンプライアンスでは、MDSAP適合性チェックリストを販売しています。

マネジメントプロセス（CH1）22,000円（税込）
機器販売承認及び施設登録（CH2）22,000円（税込）
測定、分析及び改善（CH3）22,000円（税込）
医療機器有害事象及び通知書の報告（H4）22,000円（税込）
設計・開発（CH5）22,000円（税込）
製造及びサービス管理（CH6）22,000円（税込）
購買（CH7）22,000円（税込）

ぜひご購入をご検討下さい。

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