製造販売業許可はいつまでに取得が必要か

製造販売業許可はいつまでに取得しなければならないか

日本の法律では、医療機器企業として自社ブランドの製品を上市するためには、製造販売業業許可が必要である。
医療機器の場合、製造販売する製品のリスクにより、業許可の種類が異なる。

  • 第一種製造販売業者 一般医療機器(クラスI)
  • 第二種製造販売業者 管理医療機器(クラスII)
  • 第三種製造販売業者 高度管理医療機器(クラスIII、IV)

業許可は、本社所在地(総括の常駐する建屋)の県庁の薬務課に申請を 出し、適合性調査に合格して、得ることが出来る。

製造販売業者の業務は下記の通りである。

  • 医療機器の製造販売承認/認証の取得または届け出の実施
  • 製造販売後安全管理の実施
  • 製造販売する医療機器のサプライチェーン全体を管理するQMSの運用

気を付けなければならないのは、製造販売業者は、「製造」も「販売」も出来ないということである。
「製造」する場合は、製造業登録が必要であり、販売する場合はクラスによって許可または届け出が必要である。

また製造販売業者は、下記の法的責任者である5役を揃えなければならない。

・管理監督者
・管理責任者
・医療機器総括製造販売責任者
・国内品質業務運営責任者
・安全管理責任者
業の種別によっては、兼務要件が異なるので注意が必要だ。

ところで、スタートアップ企業でしばしば問われることがある。製造販売業許可はいつまでに取得しなければならないかということである。
解答は、遅くとも品目の承認/認証までである。ただし、業許可申請が提出されていなければ、品目申請が行えないので、注意が必要である。
また先の本メルマガで記載した通り、ISO 13485の認証取得は不要である。

一方で、米国や欧州などは業許可制度がない。したがって、誰でもが医療機器を設計開発下ならば、品目申請が出来るのである。

関連商品

[blogcard url=”https://xn--2lwu4a.jp/qms-md/” title=”QMS(手順書)ひな形 医療機器関連” ]

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