tool provided for in the preceding item; 

七 病院又は診療所に、密封された放射性同位元素を装備している診療の用に供する 機器のうち、厚生労働大臣が定めるもの（以下「放射性同位元素装備診療機器」と いう。）を備えようとする場合 

(vii) when a hospital or clinic is intended to be equipped with a device to be provided for medical care which is equipped with sealed radioisotopes and which is prescribed by the Minister of Health, Labour and Welfare (hereinafter referred to as a "radioisotope-equipped medical device"); 

八 病院又は診療所に、密封されていない放射性同位元素であつて陽電子放射断層撮 影装置による画像診断に用いるもののうち、次に掲げるもの（以下「陽電子断層撮 影診療用放射性同位元素」という。）を備えようとする場合 

(viii) when a hospital or clinic is intended to be equipped with the following unsealed radioisotopes that are used in diagnostic imaging by positron emission tomography scanners (hereinafter referred to as "radioisotopes for positron tomography examination"): 

イ 第一条の十一第二項第二号ハ（２）に規定する医薬品 

(a) the pharmaceuticals provided for in Article 1-11, paragraph (2), item (ii), (c), 2.; 

ロ 医薬品医療機器等法第二十三条の二の五第一項若しくは第二十三条の二の十七 第一項の承認（医薬品医療機器等法第二十三条の二の五第十五項（医薬品医療機 器等法第二十三条の二の十七第五項において準用する場合を含む。）の変更の承 認を含む。）若しくは医薬品医療機器等法第二十三条の二の二十三第一項の認証 （同条第七項の変更の認証を含む。）を受けている体外診断用医薬品又は医薬品 医療機器等法第二十三条の二の十二第一項の規定による届出（同条第二項の規定 による変更の届出を含む。）が行われている体外診断用医薬品 

(b) in-vitro diagnostics that have obtained the approval referred to in Article 23-2-5, paragraph (1) or Article 23-2-17, paragraph (1) of the Act on Pharmaceuticals and Medical Devices (including the approval for changes referred to in Article 23-2-5, paragraph (15) of the Act on Pharmaceuticals and Medical Devices (including as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) thereof)) or that have obtained the certification referred to in Article 23-2-23, paragraph (1) of the Act on Pharmaceuticals and Medical Devices (including the certification for changes referred to in paragraph (7) of the same Article), or in-vitro diagnostics for which the notification under Article 23-2-12, paragraph (1) of the Act on Pharmaceuticals and Medical Devices (including the notification of changes under paragraph (2) of the same Article) has been made; 

ハ 第一条の十一第二項第二号ハ（１）に規定するもののうち、次に掲げるもの 

(c) those provided for in Article 1-11, paragraph (2), item (ii), (c), 1. and set forth below: 

