適用除外と非適用の違い

今年度に改正が予定されているQMS省令では、適用除外と非適用の理由説明の規定の明確化が要求される予定だ。

改正QMS省令の業界案の第四条では以下のような要求になることが説明されている。

第四条 製造販売業者等は、外部委託する工程に係る責任を負うとともに、当該工程の監視、維持及び管理を品質管理監督システムの中で明確に規定しなければならない。

製造販売業等が外部委託の責任を有すること、外部委託する工程を監視、維持、管理する責任を規定している。
つまり、アウトソースしたら製造販売業者としての責務がなくなるわけではない。
もしQMS省令の要求事項を遵守する責務がなくなるのであれば、すべての工程をアウトソースすれば良いことになってしまう。

第四条に関する逐条解説でも以下のように説明している。

  1. この省令要求する工程で、製造販売業者等が自ら実施せず、外部委託する工程においても、製造販売業者等は、当該工程に責任を負わなければならないものであること。
  2. 製造売業者等は、外部委託する工程を監視し、維持し、管理することを、品質管理監督システムの中で、明確にすることが求められるものであること。

「外部委託している」は「非適用」または「適用除外」の理由にはならないのである。

では、「非適用」と「適用除外」とは何であろうか。
改正QMS省令の業界案の第四条の第2項には以下の記載がある。

2 法第二十三条の二の五第一項に規定する医療機器及び体外診断用医薬品並びに法二十三条の二の二十三第一項に規定する指定高度管理医療機器等以外の医療機器等に係る製品については第三十七条から第四十五条までの規定を適用しない。

これが適用除外である。
法律や規制要件で除外が認められている場合、品質マニュアルに適用除外を宣言することによって自社のプロセスで適用しないことが出来る。
例えば、クラスIの医療機器は設計管理が除外できるなどである。
ここで大事なことは、たとえ法律や規制要件で適用除外が認められていたとしても、品質マニュアルで記載しておかなければならないということである。

また、改正QMS省令の業界案の第四条の第3項には以下の記載がある。

3 製造販売業者等は、製品に係る医療機器等の特性により、この章の第四節から第六節までのいずれかの規定を適用することができない場合においては、 ・・・

これが非適用である。
例えば、滅菌医療機器を製造していない場合は、当然のことながら滅菌工程がない。これも品質マニュアルで滅菌に関する要求事項が非適用である旨を宣言しておかなければならない。
能動型医療機器(埋込医療機器)なども同様である。

上記は、改正QMS省令の業界案の第四条の第4項に示されている。

4 製造販売業者等は、前二項の規定のいずれかに該当する場合においては、品質管理監督システムの基準を規定する文書(以下「品質管理監督システム基準書」という。)にその旨理由を記載しなければならない。

つまり、改正QMS省令においては、適用除外、非適用の理由説明の規定の明確化が要求されることとなる。

【お知らせ】
イーコンプライアンスでは、各種QMSのひな形を販売しております。詳細はこちら

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-MHLW-00.html” title=”【2021年度改正QMS省令対応】QMSひな形一式” content=”すでに現行QMS省令に準拠したQMSを構築されているが改正対応が必要な企業、これから医療機器に参入する企業にオススメのひな形セットです。”]

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