Guidance for the attached document to the application for Medical

January 24, 2014.
Guidance for the attached document to the
application for Medical Device Foreign
Manufacturer Accreditation
Pharmaceutical and Medical Device Agency
Office of GMP/QMS
Guidance for the attached documents to the application for Medical
Device Foreign Manufacturer Accreditation
Ⅰ
1
Facility Building Outline (Attachment 1－4）
Outline of the facility
（1） Layout of all site buildings
(Application for new accreditation for all categories)
Attach the aerial photograph, photograph of the whole buildings or outline drawing
of vicinity of the facility indicating the name of the peripheral road, and indicate the
building of the application. Illustration and photograph of part of the building, etc.
are unacceptable.
（2） Floor plan
a. Identify controlled environmental areas such as clean rooms.
(Application for new, change/addition and renewal of the accreditation for all
categories)
b. Identify Sterilization rooms
(Application for new, change/addition or renewal of the accreditation of
Sterilization category. For the renewal of the accreditation, this includes the case
that the manufacturing site has other multiple categories.)
c. Identify sterilization rooms, including the area where the chemical treatment is
performed.
(Application for new, change/addition or renewal of the accreditation of a
Designated Organism category. For the renewal of the accreditation, this
includes the case that the manufacturing site has other multiple categories.)
d.
Identify packaging and labeling, etc. areas
(Application for new, change/addition or renewal of the accreditation of
Packaging etc. category. For the renewal of the accreditation, this includes the
case that the manufacturing site has other multiple categories.)
2
Manufacturing Equipment
(1) Sterilization Equipment
If the sterilization process is performed, indicate the presence of sterilization
equipment, corresponding to the accreditation category of each application. Please
note that it is not necessary to indicate the sterilization equipment when it is not used
for the purpose of sterilization to the products, which will be exported to Japan.
Application for the accreditation of Sterilization Category
(Application for new, change/addition, or renewal of the accreditation. For the
renewal of the accreditation, this includes the case that the manufacturing site has
other multiple categories.)
・Select [Yes] and indicate the classification of sterilization
Application for the accreditation of General or Packaging etc. Category
(Application for new, change/addition, or renewal of the accreditation of General or
Packaging etc. category. For the renewal of the accreditation, this includes the case
that the manufacturing site has both general and packaging category.)
・Select [No]
Application for the accreditation of Designated Organism Category
(Application for new, change/addition, or renewal of the accreditation of
Designated Organism category. For the renewal of the accreditation, this includes
the case that the manufacturing site has other multiple category.)
・Select [Yes] and indicate the classification of Sterilization
(Ex: filter sterilization, chemical treatment etc.)
・ Select [No] when there is no process of sterilization including chemical
treatment for the application for the accreditation of Designated Organism
category as described above.
(2) If sterilized medical devices are handled
a. Select [N/A], if the product would be supplied on the market as non-sterilized
medical device. In this case, it is not necessary to indicate whether the
manufacturing area has environmental controlled areas.
b.
3
Leave the [N/A] checkbox as it is if the product would be supplied on the
market as a sterilized medical device (including, specified biological-origin
products and the cell/tissue based medical devices), and indicate whether the
manufacturing area has environmental controlled areas. However, select [N/A]
in case of the application for new, change/addition, or renewal of the
accreditation of Packaging etc. category. In this case, it is not necessary to
indicate whether the manufacturing area has environmental controlled areas.
Conformity to the Requirement of Buildings and Facilities.
(1) Indicate only one category corresponding to the application of the application
for the application of new or change/addition to the accreditation.
(2)
Indicate all the categories corresponding to the application for the application of
renewal of the accreditation.
Ⅱ
Product & Process List（Attachment 5）
(Application for new or change/addition to the accreditation categories)
1
Product Category
Indicate the trade name or the generic name of medical devices, which is expected
to be exported to Japan.
2
Manufacturing Process
Place an X in each column of the manufacturing process where it is applicable. As
described below, manufacturing process should correspond to each accreditation
category. In case of applying for addition of new category, it is not required to
describe the manufacturing process of the product, which correspond to the already
acquired accreditation category.
※For biological devices attach an outline of any additional processes.
【Example】
(1) Designated Organisms category
Applicable Manufacturing Process
No.
Product Category
Assembling
Sterilization
X
X
X
X
Package
and
Labeling, Etc.
X
X
X
X
X
X
X
X
(2) Sterilization category
Applicable Manufacturing Process
No.
Product Category
Assembling
Sterilization
X
X
X
X
Package
and
Labeling, Etc.
X
X
X
X
(3) General category
Applicable Manufacturing Process
No.
Product Category
Assembling
X
X
Sterilization
Package
and
Labeling, Etc.
X
(4) Packaging, Etc.
Applicable Manufacturing Process
No.
Product Category
Assembling
Sterilization
Package
and
Labeling, Etc.
X
※For biological devices attach an outline of any additional processes.
Ⅲ Self-Declaration by Managers of Foreign Manufacturing Facilities
（Attachment 6）(Application for accreditation of new manufacturing site)
If you submit a self-declaration in lieu of a physician’s certificate, please note the
following.
(1) Submit the self-declaration of all the executives in charge of operations
described in the application.
(2) The document need to be created within a year of the application date.
(3) Submit the original signed document
Ⅳ
Personal History of Responsible Person（Attachment 7）
(Application for accreditation of new manufacturing site)
1
Date
Created within a year of the application date.
2
Name
【Person Responsible for Manufacturing Site】of the application form.
3
Title
Indicate current title at the manufacturing site.
4
Name of Facility
【Name of Manufacturing site】of the application form.
Ⅴ
A copy of a certificate issued by government institutions etc. of where the
foreign manufacturer is located, when the country has equivalent system of
marketing license, marketing approval or marketing certification of medical
devices. (Application for accreditation of new manufacturing site)
Submit a copy of the following documents or the equivalent documents to those
listed below. Please note that when the name and the address of the manufacturing
site specified in the application can be confirmed and there is an expiration date, the
certificate should be currently valid.









Manufacturing permit issued by foreign government
Certificate of ISO13485
Certificate of EU MDD
FDA Establishment Registration Database or Certificate for Foreign Government
Certificate of Free Sales
Certificate of GMP
Register book, business license of commercial code
Certificate of conformation issued by notary
Document issued by public authority (Tax payment certification, etc.)
Ⅵ Original copy of accreditation certification of foreign manufacturer
(Application for accreditation renewal or change/addition of accreditation categories)
(1) Submit an additional category certification additionally if there is any addition
to the categories after the first application for the accreditation.
(2) Submit the currently valid certification. If the certification has expired before
the application for renewal, please note that it is necessary to apply as a new
accreditation. In case it is not possible to submit the certification under
unavoidable circumstances, such that a foreign manufacturer has discarded the
certificate by mistake, submission of Attachment 10 [Reason Why Certificate
Can Not Be Attached] is allowed in lieu of submitting the original certificate.
Ⅶ
Notes overall
If there is any deficiency in the application documents, certificate issuance might
be delayed as it may be subject to replacement depending on the contents of the
inadequacy. In addition, if there is a clerical error in the certificate a notification of
change and rewrite grant application might be necessary and it is subjected to fees.
Therefore, please confirm that there are no discrepancies and errors in the submitting
documents before the application.
Ⅷ
Attachment
Attachment 1: Facility Building Outline (Example of a new application of a
Sterilization category)
Attachment 2: Facility Building Outline (Example of the change of a Sterilization
category to a General category)
Attachment 3: Facility Building Outline (Example of the addition of a General category
to what was originally a Sterilization category)
Attachment 4: Facility Building Outline (Example of renewal of General and
Designated Organism category)
Attachment 5: Product & Process List
Attachment 6: Self-Declaration by Managers of Foreign Manufacturing Facilities
Attachment 7: Personal History of Responsible Person
Attachment 10: Reason Why Certificate Can Not Be Attached
Guidance for the attached documents to the application for in Vitro Diagnostics
Foreign Manufacturer Accreditation
Ⅰ
1
Facility Building Outline（Attachment 8）
Outline of the facility
（1） Layout of all site buildings
(Application for new accreditation for all categories)
Attach the aerial photograph, photograph of the whole buildings or outline drawing of vicinity
of the facility indicating the name of the peripheral road, and indicate the building about this
application. Illustration and photograph of part of the building, etc. are unacceptable.
（2）
Floor plan
a. Identify controlled radiological areas
(Application for new, change/addition and renewal of the accreditation of Radiological
Pharmaceutical category and radiological control areas are available. For the renewal of the
accreditation, this includes the case that the manufacturing site has other multiple
categories. )
b.
Identify packaging and labeling, etc. areas
(Application for new, change/addition or renewal of the accreditation of Packaging etc.
category. For the renewal of the accreditation, this includes the case that the manufacturing
site has other multiple categories.)
2
Manufacturing Equipment
（1）If radio pharmaceuticals handled
Application for the accreditation of Radiological Pharmaceutical category.
(Application for new, change/addition, or renewal of the accreditation. For the renewal of the
accreditation, this includes the case that the manufacturing site has other multiple categories.)
・Leave the [N/A] checkbox as it is and indicate whether the manufacturing area has
radiological control areas.
Application for the accreditation of other categories.
・Select [N/A] and it is not necessary to indicate whether the manufacturing area has
radiological control areas.
3
Conformity to Requirement for Buildings & Facilities
(1) Indicate only one category corresponding to the application of the application for the
application of new or change/addition to the accreditation.
(2) Indicate all the categories corresponding to the application for the application of renewal of
the accreditation.
Ⅱ
Product & Process List（Attachment 9）
(Application for new or change/addition to the accreditation categories)
1
Product Category
Indicate the trade name or the generic name of in vitro diagnostics, which is expected to be
exported to Japan.
2
Applicable Manufacturing Process
Place an X in each column of the manufacturing process where it is applicable. As described
below, manufacturing process should correspond to each accreditation category. In case of
applying for addition of new category, it is not required to describe the manufacturing process of
the product, which correspond to the already acquired accreditation category.
【Example】
(1) General category
Applicable Manufacturing Process
No.
Product Category
Bottling
Packaging and Seal・
Labeling
X
X
X
(2) Radiological Pharmaceutical category
Applicable Manufacturing Process
No.
Product Category
Bottling
Packaging and Seal・
Labeling
X
X
X
X
(3) Packaging, etc. category
Applicable Manufacturing Process
No.
Product Category
Bottling
Packaging and Seal・
Labeling
X
Ⅲ Self-Declaration by Managers of Foreign Manufacturing Facilities
（Attachment 6）(Application for accreditation of new manufacturing site)
If you submit a self-declaration in lieu of a physician’s certificate, please note the following.
(1) Submit the self-declaration of all the executives in charge of operations described in the
application.
(2) The document need to be created within a year of the application date.
(3) Submit the original signed document
Ⅳ
Personal History of Responsible Person（Attachment 7）
(Application for accreditation of new manufacturing site)
1
Date
Created within a year of the application date.
2
Name
【Person Responsible for Manufacturing Site】of the application form.
3
Title
Indicate current title at the manufacturing site.
4
Name of Facility
【Name of Manufacturing site】of the application form.
Ⅴ
A copy of a certificate issued by government institutions etc. of where the foreign
manufacturer is located, when the country has equivalent system of marketing license,
marketing approval or marketing certification of medical devices.
(Application for
accreditation of new manufacturing site)
Submit a copy of the following documents or the equivalent documents to those listed below.
Please note that when the name and the address of the manufacturing site specified in the
application can be confirmed and there is an expiration date, the certificate should be currently
valid.
 Manufacturing permit issued by foreign government
 Certificate of ISO13485
 Certificate of EU MDD
 FDA Establishment Registration Database or Certificate for Foreign Government
 Certificate of Free Sales
 Certificate of GMP
 Register book, business license of commercial code
 Certificate of conformation issued by notary
 Document issued by public authority (Tax payment certification, etc.)
Ⅵ
Original copy of accreditation certification of foreign manufacturer
(Application for accreditation renewal or change/addition of accreditation categories)
(1) Submit an additional category certification additionally if there is any addition to the
categories after the first application for the accreditation.
(2) Submit the currently valid certification. If the certification has expired before the
application for renewal, please note that it is necessary to apply as a new accreditation. In
case it is not possible to submit the certification under unavoidable circumstances, such that
a foreign manufacturer has discarded the certificate by mistake, submission of Attachment
10 [Reason Why Certificate Can Not Be Attached] is allowed in lieu of submitting the
original certificate.
Ⅶ
Notes overall
If there is any deficiency in the application documents, certificate issuance might be delayed
as it may be subject to replacement depending on the contents of the inadequacy. In addition, if
there is a clerical error in the certificate a notification of change and rewrite grant application
might be necessary and it is subjected to fees. Therefore, please confirm that there are no
discrepancies and errors in the submitting documents before the application.
Ⅷ
Attachment
Attachment 8: Facility Building Outline (Example of a new application of a Radiological
Pharmaceutical category)
Attachment 9: Product & Process List
Attachment 6: Self-Declaration by Managers of Foreign Manufacturing Facilities
Attachment 7: Personal History of Responsible Person
Attachment 10: Reason Why Certificate Can Not Be Attached
【別紙１】
【Attachment１】
医療機器について
滅菌区分の新規申請の場
合の記載例
構造設備の概要一覧表
Facility Building Outline
１
製造所の概要
別紙のとおり
Outline of the facility
As per attachments
２
① 滅菌器の有無
製造所の製造設備
Example of a new application of a
Sterilization category.
Manufacturing Equipment
■あり
□なし
Sterilization Equipment
Yes
No
ありの場合滅菌の種類（エチレンオキサイドガス滅菌
）
EOG-Sterilization
If "yes," provide sterilization classification
②滅菌医療機器を扱う場合
□非該当
If sterilized medical devices are handled:
製造環境の清浄管理エリアの有無
■あり
Controlled environment areas?
３
構造設備適合状況
□
Yes
薬局等構造設備規則第14条に適合
N/A
□なし
No
（一般区分）
Conformity to the Require Conforms to Article 14 of Pharmaceutical, Etc Building and F
ment of Buildings & Facil acility Enforcement Regulations (General)
ities
申請書記載の認定区分
に対応した区分を一つ
記載する。
Indicate only 1 accreditation
category corresponding to the
application
■
薬局等構造設備規則第14条の２に適合
（滅菌区分）
Conforms to Article 14-2 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Sterilized)
□
薬局等構造設備規則第14条の３に適合（特定生物等）
Conforms to Article 14-3 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Designated Organisms)
□
薬局等構造設備規則第14条の４に適合（包装等区分）
Conforms to Article 14-4 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Packaging, Etc.)
（注意）
１．「製造所の概要」の別紙について、次の（１）（２）を添付すること。
（１）製造所敷地内の建物配置図
（航空写真でも可）
（２）製造所の平面図
なお、作業所のうちクリーンルームなど製造環境の清浄管理しているエリア及
び滅菌区分の場合には滅菌室を識別し記載すること。
２．
「医療機器の製造設備」については、滅菌器の有無、並びにある場合には、その滅菌の
種類を記載すること。また、取扱い品目で滅菌医療機器がある場合は、製造環境の清浄
管理エリアの有無を記載すること。
３．「構造設備適合状況」については、該当する構造設備の適合状況を記す。
Notes
1. Include the following for "Outline of the facility":
(1) Diagram showing layout of all site buildings (aerial photograph OK)
(2) Floor plan of site, identifying controlled environment areas (including clean rooms) and
sterilization rooms (if sterilization is performed)are part of the total manufacturing area.
2. Indicate whether or not sterilized devices are manufactured, and sterilization category (if
applicable) Also, if any sterilized medical devices are handled, indicate whether any controlled
environment areas are part of the total manufacturing area.
3. Indicate the site's conformity to the applicable medical device manufacturing facility requirement
【別紙２】
【Attachment２】
滅菌区分から一般区分に
変更する場合の記載例
医療機器について
Example of the change of a
Sterilization category to General
category.
構造設備の概要一覧表
Facility Building Outline
１
製造所の概要
別紙のとおり
Outline of the facility
As per attachments
２
② 滅菌器の有無
製造所の製造設備
Manufacturing Equipment
□あり
Sterilization performed?
ありの場合滅菌の種類（
Yes
■なし
No
）
If "yes," provide sterilization classification
②滅菌医療機器を扱う場合
□非該当
If sterilized medical devices are handled:
製造環境の清浄管理エリアの有無
■あり
Controlled environment areas?
３
構造設備適合状況
■
Yes
薬局等構造設備規則第14条に適合
N/A
□なし
No
（一般区分）
Conformity to Requirement Conforms to Article 14 of Pharmaceutical, Etc Building and F
for Buildings & Facilities acility Enforcement Regulations (General)
□
変更後の認定区分を一
つ記載する。
Indicate only 1 accreditation
category after the change
薬局等構造設備規則第14条の２に適合
（滅菌区分）
Conforms to Article 14-2 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Sterilized)
□
薬局等構造設備規則第14条の３に適合（特定生物等）
Conforms to Article 14-3 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Designated Organisms)
□
薬局等構造設備規則第14条の４に適合（包装等区分）
Conforms to Article 14-4 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Packaging, Etc.)
【別紙３】
【Attachment３】
医療機器について
滅菌区分に一般区分を追加
する場合の記載例
構造設備の概要一覧表
Facility Building Outline
１
製造所の概要
別紙のとおり
Outline of the facility
As per attachments
２
① 滅菌器の有無
製造所の製造設備
Example of
the addition of a
General category to what was
originally Sterilization category.
Manufacturing Equipment
□あり
■なし
Yes
No
）
Sterilization performed?
ありの場合滅菌の種類（
If "yes," provide sterilization classification
②滅菌医療機器を扱う場合
■非該当
If sterilized medical devices are handled:
製造環境の清浄管理エリアの有無
□あり
Controlled environment areas?
３
構造設備適合状況
■
Yes
薬局等構造設備規則第14条に適合
N/A
□なし
No
（一般区分）
Conformity to Requirement Conforms to Article 14 of Pharmaceutical, Etc Building and F
for Buildings & Facilities acility Enforcement Regulations (General)
□
追加する認定区分を一つ記
載する。
Indicate only 1 accreditation
category to be added.
薬局等構造設備規則第14条の２に適合
（滅菌区分）
Conforms to Article 14-2 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Sterilized)
□
薬局等構造設備規則第14条の３に適合（特定生物等）
Conforms to Article 14-3 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Designated Organisms)
□
薬局等構造設備規則第14条の４に適合（包装等区分）
Conforms to Article 14-4 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Packaging, Etc.)
【別紙４】
【Attachment４】
医療機器について
構造設備の概要一覧表
Facility Building Outline
１
製造所の概要
一般区分と特定生物等区分を
更新する場合の記載例
Example of renewal of
General
and Designated Organisms category.
別紙のとおり
Outline of the facility
As per attachments
２
① 滅菌器の有無
製造所の製造設備
Manufacturing Equipment
■あり
Sterilization performed?
Yes
ありの場合滅菌の種類（濾過滅菌
□なし
No
）
Filter-Sterilization
If "yes," provide sterilization classification
②滅菌医療機器を扱う場合
□非該当
If sterilized medical devices are handled:
製造環境の清浄管理エリアの有無
■あり
Controlled environment areas?
３
構造設備適合状況
■
Yes
薬局等構造設備規則第14条に適合
N/A
□なし
No
（一般区分）
Conformity to Requirement Conforms to Article 14 of Pharmaceutical, Etc Building and F
for Buildings & Facilities acility Enforcement Regulations (General)
□
薬局等構造設備規則第14条の２に適合
（滅菌区分）
更新する全ての認定区分を
記載する。
Conforms to Article 14-2 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Sterilized)
Indicate all
renewed
■
categories
to
be
薬局等構造設備規則第14条の３に適合（特定生物等）
Conforms to Article 14-3 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Designated Organisms)
□
薬局等構造設備規則第14条の４に適合（包装等区分）
Conforms to Article 14-4 of Pharmaceutical, Etc Building and
Facility Enforcement Regulations (Packaging, Etc.)
【別紙５】
【Attachment５】
医療機器について
製造品目及び製造工程に関する資料
Product & Process List
製造所の名称
Manufacturer : ABC CO., Ltd
品
No.
１
目
製造工程
（Applicable Manufacturing Process）
Product Category
大動脈用ステントグラフ
ト
Aortic stent graft
組立て
滅菌
Assembling
Sterilization
X
X
包装等
Package and Labeli
ng, Etc.
X
（注意）
１．「品目」欄には、医療機器の販売名を記載しなくても一般的名称等の製品の種類の
記載でよい。
２．「製造工程」欄には、品目に対応する各製造工程の箇所に×印を入れる。
３．なお、生物由来製品等の品目については、別途製造工程の概要を添付すること。
Notes
1."Product Category" does not require the trade name of the medical device, the generic name or
similar category is sufficient.
2.Place an X in the applicable space for each manufacturing process which is performed for the
product.
3.For biological devices attach an outline of any additional processes.
【別紙６】
【Attachment６】
SELF-DECLARATION BY MANAGERS
OF
MANUFACTURING FACILITIES
FOREIGN
<自己宣言書>
The undersigned acknowledges that he/she is the (Vice president) of the m
anufacturing facility located at (ZZZ, NewYork,10091,U.S.A.) , and affirms that
he/she has no mental or physical disability that prevents him/her from perfor
ming, with or without reasonable accommodation,the essential functions of hi
s/her status as (Vice president) , and does not currently engage in the illeg
al use of drugs.
翻訳）下記の署名者は（ZZZ, NewYork,10091,U.S.A.）にある工場の（Vice president
）であり、補助用具等の有無に係らず、
（Vice president）に要求される業務に支障をき
たす精神障害又は身体障害はなく、麻薬などを使用していないことを宣言します。
Name of facility:
ABC CO., Ltd
Address of facility: ZZZ, NewYork,10091,U.S.A.
Date:
20XX.1.1.
Signature:
Printed name:
直筆の署名
一年以内の日付
Within a year of
application date
Signing autograph.
**********
This self-declaration is being submitted in lieu of a physician's certificate,
which may pose a conflict with the privacy, employment, and/or human
resource related regulations in my country of residence.
翻訳）この自己宣言書は、医師の診断書の提出が当国におけるプライバシーに関する規
則、雇用に関す規則、又は人事に関する規則に抵触するため、医師の診断書に替えて提
出するものである。
【別紙７】
【Attachment７】
製造所の責任者の履歴
Personal History of Responsible Person
一年以内の日付
20XX.1.1.
作成日 Date
Within a year of
application date
*********
責任者氏名 Name
Plant manager
職名 Title
製造所の名称
ABC CO., Ltd
Name of Facility
上記の者の（
ABC CO., Ltd
）社における履歴は、以下のとおり
This is to state the personal history of the person above.
Employment History in
ABC CO., Ltd
期間 From-To
職位／担当
2011-2013
Quality Engineer
2013-present
Plant manager
現在までの履歴を
記載する
Indicate the history up
to the present.
Status/Responsibility
【別紙８】
放射性医薬品区分の新規申
請の場合の記載例
【Attachment８】
Example of a new application of a
Radiological Pharmaceutical category
体外診断用医薬品について
構造設備の概要一覧表
Facility Building Outline
１
製造所の概要
別紙のとおり
Outline of the facility
As per attachments
２
放射性医薬品を扱う場合
製造所の製造設備
Manufacturing Equipment
If radio pharmaceuticals handled:
放射性管理区域の有無
Radiological control areas available?
３
構造設備適合状況
□
□非該当
N/A
■あり □なし
Yes
薬局等構造設備規則第６条に適合
No
（一般区分）
Conformity to Requirement Conforms to Article 6 of Pharmaceutical, Etc Building and Fa
for Buildings & Facilities cility Enforcement Regulations (General)
■
薬局等構造設備規則第９条に適合（放射性医薬品区分）
Conforms to Article 9 of Pharmaceutical, Etc Building and Fa
cility Enforcement Regulations (Radiological Pharmaceuticals)
□
薬局等構造設備規則第１０条に適合
（包装等区分）
Conforms to Article 10 of Pharmaceutical, Etc Building and F
acility Enforcement Regulations (Packaging, etc)
（注意）
１．「製造所の概要」の別紙について、次の（１）（２）を添付すること。
（１）製造所敷地内の建物配置図
（航空写真でも可）
（２）製造所の平面図
なお、作業所のうち放射性医薬品区分の場合には放射性管理区域を識別し記載
すること。
２．
「体外診断用医薬品の製造設備」については、放射性医薬品のある場合には、放射性管
理区域の有無を記載すること。
３．「構造設備適合状況」については、該当する構造設備の適合状況を記す。
Notes
1. Include the following for "Outline of the facility":
(1) Diagram showing layout of all site buildings (aerial photograph OK)
(2) Floor plan of site, identifying controlled radiological areas (if radio pharmaceuticals are
handled).
2. For "In vitro diagnostic manufacturing equipment," if radio pharmaceuticals are manufactured
indicate whether radiological control area are available .
3. Indicate the site's conformity to the applicable in vitro diagnostics manufacturing facility
requirements.
【別紙９】
【Attachment９】
体外診断用医薬品について
製造品目及び製造工程に関する資料
Product & Process List
製造所の名称
Manufacturer :
製造工程
品目
No.
Product
Category
（Applicable Manufacturing Process）
最終容器充填
Bottling
包装（キット製品の組立を含む。）・表示
Packaging and
１
グルコースキット
Glucose kit
X
Seals ・Labeling
X
（注意）
１．「品目」の欄には、体外診断用医薬品の販売名を記載しなくても一般的名称等、製
品の種類の記載でよい。
２．「製造工程」の欄には、品目に対応する各製造工程の箇所に×印を入れる。
Notes
1."Product Category" does not require the trade name of the in vitro diagnostics, the generic name
or similar category is sufficient.
2.Place an X in the applicable space for each manufacturing process being carried out of the
product.
【別紙１０】
【Attachment１０】
認定証を添付できない理由
Reason Why Certificate Can Not Be Attached
厚生労働大臣殿
To: Minister of Health, Labour and Welfare
外国製造業者更新申請書
外国製造業者区分変更・追加申請書
の申請にあたり、認定証を添付できない理由は以下のとおりです。
Due to the following reason, no certificate can be attached to this application for
Manufacturing Site Accreditation Renewal
Change/Addition of Manufacturing Category
（理
由）認定証を紛失したため。
Reason: Because the certificate was lost.
（認定証）Certificate Content
１認定番号 Accreditation Number: BG99999999
２認定年月日 Accreditation Date: 20XX.2.2.
３申請者の住所 Applicant Address: ZZZ, NewYork,10091,U.S.A.
４申請者の氏名 Applicant Name: ABC CO., Ltd
５製造所の所在地 Facility Address: ZZZ, NewYork,10091,U.S.A.
６製造所の名称 Facility Name: ABC CO., Ltd
７認定の区分 Accreditation Category: 滅菌 Sterilization
平成
20XX
年
3 月
3
日 Date: YY/MM/DD
（申請者）Applicant Information
住所 Address
ZZZ, NewYork,10091,U.S.A.
氏名 Name ABC CO., Ltd. Vice president ＊＊＊＊＊＊
㊞又は署名 [Seal or Signature]
直筆の署名
Signing autograph.

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