日本醫療器材登記法規問題集
日本東京與臺灣同事攜手協同爲您服務: 安排日本DMAH (Designated Marketing Authorization Holder); 外國製造商在日本註冊登記 (FMR);品質管理系統 (MHLW MO169)稽核;上市前註冊/認證/審批 (Marketing approval，製造販売承認)。
Email：tyo4ww@evershinecpa.com
或
日本永輝BPO有限公司Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
接洽人:
丘玲恵（Kyu Reike）日本籍来自台灣
王礼芳（Lily Wang）日本永居来自福建
或
聯絡人: 林幸穗 Anny Lin 協理
手機：+886-937-606-272
skype: annylin8008
wechat: annylin8008
電話：+886-2-2717-0515 分機:110
HLF-JP-10
請問日本對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of medical devices in Japan? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?
Evershine RD：
在日本，醫療器材被定義為具有明確定義的結構、使用方法、效果和性能的經批准的醫療產品，其使用目的是“診斷、治療或預防疾病”或“影響人體的結構或功能”。
醫療器材受厚生勞動省 (MHLW)和藥品和醫療器材局 (PMDA)監管。
MHLW負責法律框架的管理和監督，PMDA是一個獨立機構，與厚生勞動省一起評估醫療器材的安全性、有效性，以及對醫療器材的上市許可申請進行科學審查，監測其上市後的安全性，按風險由低至高分類，每個設備都會根據其對人體的特定風險進行審查，以避免出現問題。
1.第一級：一般醫療器材。
‧產品採自我聲明，不需要批准，但銷售前需要銷售通知。
2.第二級：指定和特別管制醫療器材。
‧產品需要經過厚生勞動省授權的第三方註冊認證機構(RCB)的認證且經PMDA 批准。
3.第三級：特別高度管制醫療器材。
‧由厚生勞動省授權的第三方註冊認證機構(RCB)或 PMDA 審查。
4.第四級：高度管制醫療器材。
‧必須由 PMDA 審查並由 MHLW 批准。
In Japan, a medical device is defined as an approved medical product with a well-defined structure, method of use, effect, and performance, and its use is for the purpose of “diagnosing, treating, or preventing disease” or “affecting the structure or function of the human body.”
Medical devices are regulated by the Ministry of Health, Labour and Welfare (MHLW) and the Drugs and Medical Devices Agency (PMDA).
The MHLW is responsible for the management and supervision of the legal framework, and the PMDA is an independent agency that, together with the Ministry of Health, Labour and Welfare, evaluates the safety, efficacy of medical devices, and conducts scientific reviews of applications for marketing authorization of medical devices, monitoring their post-market safety, Classified from low to high risk, each device is reviewed for its specific risk to the human body in order to avoid problems.
1. Class 1: general medical equipment.
‧Products are self-declared and do not require approval, but a sales notification is required before sale.
2. Class 2: Designated and specially controlled medical devices.
‧Products need to be certified by a third-party Registration Certification Body (RCB) authorized by the Ministry of Health, Labour and Welfare and approved by PMDA.
3. Class 3: Specially highly regulated medical equipment.
‧Reviewed by a third-party Registration Certification Body (RCB) or PMDA authorized by the Ministry of Health, Labour and Welfare.
4. Class 4: Highly regulated medical equipment.
‧Must be reviewed by the PMDA and approved by the MHLW.
【參考連結】
https://www.pmda.go.jp/review-services/drug-reviews/0001.html
https://www.std.pmda.go.jp/stdDB/index_en.html
HLF-JP-20
外國公司要到日本銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell medical devices in Japan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要。於公司登記時需要設有規定人員，並於銷售前根據欲販售的醫療器材級別取得醫療器材製造販賣業許可證。
1.第一級：第三種醫療器材製造販賣業許可證。
2.第二級：第二種醫療器材製造販賣業許可證。
3.第三級：第一種醫療器材製造販賣業許可證。
4.第四級：第一種醫療器材製造販賣業許可證。
欲取得醫療器材製造販賣業許可證之企業需要設有規定之人員
1. 統籌製造販賣負責人1名：
依據醫療器材級別、分類不同，所需負責人的資格條件如下。
第一級
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一專業課程。
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一學科後，從事醫藥品或醫療器材的品質管理或安全管理等方面之業務三年或以上。
第二、三、四級：
．大學或高等專業學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一專業課程。
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一學科後，從事醫藥品或醫療器材的品質管理或安全管理等方面之業務三年或以上。
．從事醫藥品或醫療器材的品質管理或安全管理等方面之業務五年或以上，且參加並修得厚生勞動省開辦的講習。
2. 國內品質業務運營負責人1名：
主要負責醫療器材的品質管理，應符合以下條件
．具備妥善處理醫療器材品質保證業務能力
．具有3年以上從事品質保證的相關經驗
．必須是品質保證部門負責人
．醫療器材銷售部門的員工不得擔任
．管理產品的良好質量規範 (GQP)
3. 安全管理負責人1名：
負責蒐集並處理安全管理信息，建立安全確保措施、實施措施，應符合以下條件
．必須是安全管理統籌部門負責人(限申請第一種醫療器材製造販賣業許可證)
．具有3年以上從事醫療器材安全管理的相關經驗(限申請第一種醫療器材製造販賣業許可證)
．具備妥善處理醫療器材安全管理業務能力
．醫療器材的安全管理工作與其他方面的安全管理工作不衝突
．醫療器材銷售相關部門的員工不得擔任
．執行良好警戒實踐 (GVP)
申請資料：
1.申請書(個人/法人)
．從業者編碼
．姓名/法人名稱
．地址/法人登陸地址
．事務所名稱
．事務所地址
．相關負責人身份訊息
2.法人登記證明書及業務分配表(如申請人為法人)
3.非大麻等成癮者的陳述
4.統籌製造業販賣負責人的雇傭證書
5.統籌製造業販賣負責人的學歷證明、從業年數證明書
6.事務所相關圖紙
7.製造管理及品質管理體系的相關資料
8.安全管理體系的相關資料
It is necessary to have prescribed personnel, and obtain a medical device manufacturing and sales license according to the level of the medical device to be sold before sales.
1. Class 1:The third type of medical device manufacturing and sales license.
2. Class 2:The second type of license for the manufacture and sale of medical device.
3. Class 3:The first type of medical device manufacturing and sales license.
4. Class 4:The first license for the manufacture and sale of medical device.
Companies that want to obtain a license for the manufacture and sale of medical deviceneed to have prescribed personnel
1.
One person in charge of overall manufacturing and sales:
According to the level and classification of medical device, the qualifications of the person in charge are as follows.
Class 1
．High school or equivalent school to complete any one of the professional courses in physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, me
dicine, and dentistry.
．After high school or equivalent school completed any one of physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, dental medicine, engaged in the quality management or safety of medicines or medical device three years or more in management and other aspects of the business.
Class 2.3.4
．University or higher professional schools have completed any professional courses in physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, and dentistry.
．After high school or equivalent school completed any one of physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, dental medicine, engaged in the quality management or safety of medicines or medical device Three years or more in management and other aspects of the business.
．Have been engaged in the quality management or safety management of pharmaceuticals or medical device for five years or more, and have participated in and completed training courses offered by the Ministry of Health, Labour and Welfare.
2.
1 person in charge of domestic quality business operation:
mainly responsible for the quality management of medical device, should meet the following conditions
．Possess the ability to properly handle medical device quality assurance business
．More than 3 years of relevant experience in quality assurance
．Must be the person in charge of the quality assurance department
．Employees of the medical device sales department shall not be
．Good quality practice (GQP) for managing products
3.
1 person in charge of safety management:
responsible for collecting and processing safety management information, establishing safety assurance measures and implementing measures, and meeting the following conditions
．Must be the person in charge of the safety management and coordination department (restricted to apply for the first type of medical device manufacturing and selling license)
．Have more than 3 years of relevant experience in medical device safety management (limited to apply for the first type of medical device manufacturing and sales license)
．Possess the ability to properly handle medical device safety management business
．The safety management of medical device does not conflict with the safety management of other aspects
．Employees of relevant departments of medical device sales shall not be
．Implement Good Vigilance Practice (GVP)
Application information:
1. Application Form (Individual / Legal Person)
．Practitioner coding
．Name/Corporate Name
．Address / Legal person login address
．Firm name
．Office address
．Information about the identity of the person in charge
2. Legal person registration certificate and business allocation form (if the applicant is a legal person)
3. Statements from addicts who are not addicts such as marijuana
4. The employment certificate of the person in charge of manufacturing sales
5. Certificate of education and years of experience of the person in charge of the overall manufacturing sales
6. Office-related drawings
7. Relevant information of manufacturing management and quality management system
8. Relevant information on safety management system
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html
https://www.pmda.go.jp/index.html
HLF-JP-25
HLF-JP-30
外國公司要到日本銷售醫療器材，可以指派日本公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？
外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell medical devices in Japan, can it assign a Japan company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。
於公司登記時需要設有規定人員，並於銷售前根據欲販售的醫療器材級別取得醫療器材製造販賣業許可證。
1.第一級：第三種醫療器材製造販賣業許可證。
2.第二級：第二種醫療器材製造販賣業許可證。
3.第三級：第一種醫療器材製造販賣業許可證。
4.第四級：第一種醫療器材製造販賣業許可證。
欲取得醫療器材製造販賣業許可證之企業需要設有規定之人員
1. 統籌製造販賣負責人1名：
依據醫療器材級別、分類不同，所需負責人的資格條件如下。
第一級
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一專業課程。
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一學科後，從事醫藥品或醫療器材的品質管理或安全管理等方面之業務三年或以上。
第二、三、四級：
．大學或高等專業學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一專業課程。
．高中或同等以上學校修得物理學、化學、生物學、工學、訊號學、金屬學、電學、機械學、醫藥學、牙齒醫學中任一學科後，從事醫藥品或醫療器材的品質管理或安全管理等方面之業務三年或以上。
．從事醫藥品或醫療器材的品質管理或安全管理等方面之業務五年或以上，且參加並修得厚生勞動省開辦的講習。
2. 國內品質業務運營負責人1名：
主要負責醫療器材的品質管理，應符合以下條件
．具備妥善處理醫療器材品質保證業務能力
．具有3年以上從事品質保證的相關經驗
．必須是品質保證部門負責人
．醫療器材銷售部門的員工不得擔任
．管理產品的良好質量規範 (GQP)
3. 安全管理負責人1名：
負責蒐集並處理安全管理信息，建立安全確保措施、實施措施，應符合以下條件
．必須是安全管理統籌部門負責人(限申請第一種醫療器材製造販賣業許可證)
．具有3年以上從事醫療器材安全管理的相關經驗(限申請第一種醫療器材製造販賣業許可證)
．具備妥善處理醫療器材安全管理業務能力
．醫療器材的安全管理工作與其他方面的安全管理工作不衝突
．醫療器材銷售相關部門的員工不得擔任
．執行良好警戒實踐 (GVP)
申請資料：
1.申請書(個人/法人)
．從業者編碼
．姓名/法人名稱
．地址/法人登陸地址
．事務所名稱
．事務所地址
．相關負責人身份訊息
2.法人登記證明書及業務分配表(如申請人為法人)
3.非大麻等成癮者的陳述
4.統籌製造業販賣負責人的雇傭證書
5.統籌製造業販賣負責人的學歷證明、從業年數證明書
6.事務所相關圖紙
7.製造管理及品質管理體系的相關資料
8.安全管理體系的相關資料
當醫療器材有安全疑慮，發現懷疑有副作用或傳染病的病例時，依據藥品、醫療器材安全保障法，製造商和分銷商有義務向PMDA 報告，申報方法等因項目的種類而異，參閱IKW 網站：
https://ikw.info.pmda.go.jp/fuguai/kiki-new.html
附表的申報方式有兩種：上傳到受理現場、EDI發送、紙本申報。
Yes. It is necessary to have prescribed personnel, and obtain a medical device manufacturing and sales license according to the level of the medical device to be sold before sales.
1. Class 1:The third type of medical device manufacturing and sales license.
2. Class 2:The second type of license for the manufacture and sale of medical device.
3. Class 3:The first type of medical device manufacturing and sales license.
4. Class 4:The first license for the manufacture and sale of medical device.
Companies that want to obtain a license for the manufacture and sale of medical deviceneed to have prescribed personnel
1.
One person in charge of overall manufacturing and sales:
According to the level and classification of medical device, the qualifications of the person in charge are as follows.
Class 1
．High school or equivalent school to complete any one of the professional courses in physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, and dentistry.
．After high school or equivalent school completed any one of physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, dental medicine, engaged in the quality management or safety of medicines or medical deviceThree years or more in management and other aspects of the business.
Class 2.3.4
．University or higher professional schools have completed any professional courses in physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, and dentistry.
．After high school or equivalent school completed any one of physics, chemistry, biology, engineering, signal science, metal science, electricity, mechanics, medicine, dental medicine, engaged in the quality management or safety of medicines or medical device Three years or more in management and other aspects of the business.
．Have been engaged in the quality management or safety management of pharmaceuticals or medical device for five years or more, and have participated in and completed training courses offered by the Ministry of Health, Labour and Welfare.
2.
1 person in charge of domestic quality business operation:
mainly responsible for the quality management of medical device, should meet the following conditions
．Possess the ability to properly handle medical device quality assurance business
．More than 3 years of relevant experience in quality assurance
．Must be the person in charge of the quality assurance department
．Employees of the medical device sales department shall not be
．Good quality practice (GQP) for managing products
3.
1 person in charge of safety management:
responsible for collecting and processing safety management information, establishing safety assurance measures and implementing measures, and meeting the following conditions
．Must be the person in charge of the safety management and coordination department (restricted to apply for the first type of medical device manufacturing and selling license)
．Have more than 3 years of relevant experience in medical device safety management (limited to apply for the first type of medical device manufacturing and sales license)
．Possess the ability to properly handle medical device safety management business
．The safety management of medical device does not conflict with the safety management of other aspects
．Employees of relevant departments of medical device sales shall not be
．Implement Good Vigilance Practice (GVP)
Application information:
1. Application Form (Individual / Legal Person)
．Practitioner coding
．Name/Corporate Name
．Address / Legal person login address
．Firm name
．Office address
．Information about the identity of the person in charge
2. Legal person registration certificate and business allocation form (if the applicant is a legal person)
3. Statements from addicts who are not addicts such as marijuana
4. The employment certificate of the person in charge of manufacturing sales
5. Certificate of education and years of experience of the person in charge of the overall manufacturing sales
6. Office related drawings
7. Relevant information of manufacturing management and quality management system
8. Relevant information on safety management system
When there are concerns about the safety of medical equipment and cases of suspected side effects or infectious diseases are found, according to the Drugs and Medical Equipment Safety and Security Act, manufacturers and distributors are obliged to report to PMDA. The reporting method varies depending on the type of item, see IKW website:
https://ikw.info.pmda.go.jp/fuguai/kiki-new.html
There are two ways to declare the attached form: uploading to the acceptance site, sending by EDI, and paper declaration.
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html
https://www.pmda.go.jp/index.html
https://www.pmda.go.jp/safety/reports/mah/0006.html
HLF-JP-35
HLF-JP-40
外國公司銷售到日本醫療器材本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了日文外，其他哪種語文也可以？網頁？
Do foreign companies need to apply for an approval before importing medical devices sold to Japan?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
需要。製造商須完成產品許可，如為外國製造商且在日本無實體公司，可以委託上市許可持有人 (MAH) /指定上市許可持有人 (DMAH)代為辦理。
上市許可持有人 (MAH)
1.由MAH擔任申請人，負責產品註冊，且為產品批准/認證的所有者。
2.當需要提交補充申請或批准/認證的轉讓申請時，MAH可以在其權限範圍內提交此類申請，不需要獲得外國製造商的簽名，因為 MAH 是產品所有者。
指定上市許可持有人 (DMAH)
1. 由外國製造商擔任申請人，DMAH代為申請，外國製造商為產品批准/認證的所有者。
2. 在產品註冊期間和之後，DMAH 充當外國製造商的代表，產品註冊申請透過DMAH提交，但需要外國製造商簽字。
3. 當需要提交補充申請或批准/認證的轉讓申請時，儘管申請是通過DMAH提交的，但仍需要外國製造商代表的簽名。
資格
上市許可持有人 (MAH)、指定上市許可持有人 (DMAH)須為在日本當地的實體公司，並取得製造販賣業許可正。
產品許可
需依照醫療器材的級別及分類進行產品許可，取得認證。
1.第一級：一般醫療器材。必須向PMDA提交一份上市前註冊申請。申請為通告性文件，PMDA不會做出任何審查意見。
2.第二級：指定和特別管制醫療器材。產品需要經過厚生勞動省授權的第三方註冊認證機構(RCB)的認證且經PMDA 批准。
3.第三級：特別高度管制醫療器材。由厚生勞動省授權的第三方註冊認證機構(RCB)或 PMDA 審查。
4.第四級：高度管制醫療器材。必須由 PMDA 審查並由 MHLW 批准。
*所有提交文件必須是日文。
提交 QMS（質量管理體系）資料：
將通知申請人每個設施的調查方法（現場調查或書面調查）。
1. 宣誓書
2. 調查設施概要：
只接受與申請者獲得批准（認證）或已提交製造和銷售通知的項目有關的信息。
．設備名稱、設施位置、編號
．員工人數（包括兼職員工）、員工總數 、人力製造部
．製造（製造和銷售）件數、
．重要供應商的名稱、地點、流程、設施名稱、位置、過程
．描述有供應採購產品的設施或外包過程的設施，這對產品的有效性和安全性有特殊影響。
3. 子項目清單：依據申請的醫療器材對照編碼(JMDN)
4. 品質管理宣誓書
5. 申請書
．申請人名稱
．負責人姓名
．所屬部門名稱
．電話
．傳真
．項目名稱
．設施名稱
．製造商
．設計
．主要組裝
．滅菌
．出貨
如果與符合性調查申請相關的所有設施的調查完成並且調查結果符合要求，將向申請人郵寄以下文件。
1.合格證書或附加結果證書
2.醫療器材/體外診斷藥物相容性調查結果通知書複印件
3.符合藥品醫療器材執法條例規定的文件（如適用）
4.QMS 調查結果總結報告副本
5.QMS 調查結果報告的副本（僅當有進行現場調查的設施時）
醫療器材的包裝與標示，須包含
1.製造商的名稱和地址
2.名稱
3. 序列號或序列碼
4.重量、容量或數量等內容
5.使用期限
6.類別：高度管理醫療器材、管理醫療器材、一般醫療器材
7. 外國製造的醫療器材的名稱、國名、地址
8.經銷商的名稱和地址
9. 認證持有人的姓名
10. 維護管理醫療設備的事實
11.單次使用的器材需標註“一次性使用”一詞外，還應使用“禁止重複使用”、“僅使用一次”等明確表示一次性使用的用語，只有符號是不允許的。
12. 使用方法及其他必要的使用和處理注意事項
13. 維護檢查相關事項
14. 厚生勞動省令規定的事項
15. 禁止
・可能是虛假或誤導的事項
・未經批准的適應症、效果或性能
・對健康和衛生有危險的用法、用量或使用期限
16.醫療器材製造和銷售許可證號+16位項目特定編號，例如從000001開始按製造和銷售通知順序的序列號要數。
*必需在容器包裝上以日文標示。
Manufacturers must complete product licensing. If they are foreign manufacturers and do not have a physical company in Japan, they can entrust a Marketing Authorization Holder (MAH) / Designated Marketing Authorization Holder (DMAH) to do so.
Marketing Authorization Holder (MAH)
1. MAH is the applicant, responsible for product registration, and is the owner of product approval/certification.
2. When a supplementary application or an approved/certified transfer application needs to be submitted, the MAH may submit such application within its purview, without the need to obtain the signature of the foreign manufacturer, as the MAH is the product owner.
Designated Marketing Authorization Holder (DMAH)
1. The foreign manufacturer is the applicant, DMAH is the applicant, and the foreign manufacturer is the owner of the product approval/certification.
2. During and after the product registration, DMAH acts as the representative of the foreign manufacturer, and the product registration application is submitted through DMAH, but requires the signature of the foreign manufacturer.
3. When a supplementary application or an approved/certified transfer application needs to be submitted, the signature of the representative of the foreign manufacturer is required even though the application is submitted through DMAH.
Eligibility
The Marketing Authorization Holder (MAH) and the Designated Marketing Authorization Holder (DMAH) must be a local entity in Japan with a manufacturing and sales license.
Product Licensing
It is necessary to carry out product licensing and obtain certification according to the grade and classification of medical devices.
1. Class 1: General medical equipment. A premarket registration application must be submitted to the PMDA. The application is a notification document, and PMDA will not make any review opinion.
2. Class 2: Designated and Specially Controlled Medical Devices. Products need to be certified by a third-party registered certification body (RCB) authorized by the Ministry of Health, Labour and Welfare and approved by PMDA.
3. Class 3: Specially highly regulated medical equipment. Reviewed by a third-party registered certification body (RCB) or PMDA authorized by the Ministry of Health, Labour and Welfare.
4. Class 4: Highly regulated medical equipment. Must be reviewed by the PMDA and approved by the MHLW.
*All submitted documents must be in Japanese.
Submit QMS (Quality Management System) information:
Applicants will be informed of the survey method (on-site or written survey) for each facility.
1. Affidavit
2. Survey Facility Summary:
Only information pertaining to an item for which the applicant has been approved (certified) or has submitted a manufacturing and sales notification will be accepted.
．Equipment name, facility location, number
．Number of employees (including part-time employees), total number of employees, manpower manufacturing department
．Number of pieces manufactured (manufactured and sold),
．Names, locations, processes, facility names, locations, processes of significant suppliers
．Describe a facility that supplies purchased product or a facility that outsources processes that have a particular impact on the effectiveness and safety of the product．
3. List of sub-items: Medical Device Control Code (JMDN) according to the application
4. Affidavit of Quality Management
5. Application
． Applicant’s name
． Person in charge
． Department name
． Telephone
． Fax
． Project name
． Facility name
． Manufacturers
． Design
． Primary assembly
． Sterilize
． Shipping
The following documents will be mailed to the applicant if the survey of all facilities related to the compliance survey application is completed and the results of the survey are satisfactory.
1. Certificate of Qualification or Certificate of Additional Results
2. A copy of the notification letter of the compatibility investigation of medical devices/in vitro diagnostic drugs
3. Documents in compliance with the regulations on drug and medical device law enforcement (if applicable)
4. A copy of the QMS findings summary report
5. A copy of the QMS survey results report (only if there are facilities to conduct on-site surveys)
Packaging and labelling of medical devices must include
1. Manufacturer’s name and address
2. Name
3. Serial number or serial code
4. Contents such as weight, capacity or quantity
5. Term of use
6. Category: highly managed medical equipment, managed medical equipment, general medical equipment
7. Name, country name, address of foreign-made medical device
8. Distributor’s name and address
9. The name of the certification holder
10. Facts about maintaining and managing medical equipment
11. In addition to the word “single-use”, the single-use equipment should be marked with the words “repeated use prohibited”, “only used once” and other terms that clearly indicate single-use use. Only symbols are not allowed.
12. How to use and other necessary precautions for use and handling
13. Items related to maintenance and inspection
14. Matters stipulated by ordinance of the Ministry of Health, Labour and Welfare
15. Prohibited
・ Matters that may be false or misleading
・Unapproved indications, effects or properties
・Usage, dosage or duration of use that is dangerous to health and hygiene
16. Medical device manufacturing and sales license number + 16-digit item-specific number, such as serial numbers starting from 000001 in the order of manufacturing and sales notification.
*Must be marked in Japanese on the container and packaging.
【參考連結】
https://www.pmda.go.jp/review-services/gmp-qms-gctp/qms/0003.html
https://www.std.pmda.go.jp/stdDB/index_en.html
HLF-JP-45
HLF-JP-50
外國公司可以用自己名義申請辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了日文外，其他哪種語文也可以？網頁？
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
不行。
外國製造商若在日本無實體公司，須委託上市許可持有人 (MAH) /指定上市許可持有人 (DMAH)代為辦理。
上市許可持有人 (MAH)
1.由MAH擔任申請人，負責產品註冊，且為產品批准/認證的所有者。
2.當需要提交補充申請或批准/認證的轉讓申請時，MAH可以在其權限範圍內提交此類申請，不需要獲得外國製造商的簽名，因為 MAH 是產品所有者。
指定上市許可持有人 (DMAH)
1. 由外國製造商擔任申請人，DMAH代為申請，外國製造商為產品批准/認證的所有者。
2. 在產品註冊期間和之後，DMAH 充當外國製造商的代表，產品註冊申請透過DMAH提交，但需要外國製造商簽字。
3. 當需要提交補充申請或批准/認證的轉讓申請時，儘管申請是通過DMAH提交的，但仍需要外國製造商代表的簽名。
資格
上市許可持有人 (MAH)、指定上市許可持有人 (DMAH)須為在日本當地的實體公司，並取得製造販賣業許可正。
產品許可
需依照醫療器材的級別及分類進行產品許可，取得認證。
1.第一級：一般醫療器材。必須向PMDA提交一份上市前註冊申請。申請為通告性文件，PMDA不會做出任何審查意見。
2.第二級：指定和特別管制醫療器材。產品需要經過厚生勞動省授權的第三方註冊認證機構(RCB)的認證且經PMDA 批准。
3.第三級：特別高度管制醫療器材。由厚生勞動省授權的第三方註冊認證機構(RCB)或 PMDA 審查。
4.第四級：高度管制醫療器材。必須由 PMDA 審查並由 MHLW 批准。
*所有提交文件必須是日文。
提交 QMS（質量管理體系）資料：
將通知申請人每個設施的調查方法（現場調查或書面調查）。
1. 宣誓書
2. 調查設施概要：只接受與申請者獲得批准（認證）或已提交製造和銷售通知的項目有關的信息。
．設備名稱、設施位置、編號
．員工人數（包括兼職員工）、員工總數 、人力製造部
．製造（製造和銷售）件數、
．重要供應商的名稱、地點、流程、設施名稱、位置、過程
．描述有供應採購產品的設施或外包過程的設施，這對產品的有效性和安全性有特殊影響。
3. 子項目清單：依據申請的醫療器材對照編碼(JMDN)
4. 品質管理宣誓書
5. 申請書
．申請人名稱
．負責人姓名
．所屬部門名稱
．電話
．傳真
．項目名稱
．設施名稱
．製造商
．設計
．主要組裝
．滅菌
．出貨
如果與符合性調查申請相關的所有設施的調查完成並且調查結果符合要求，將向申請人郵寄以下文件。
1.合格證書或附加結果證書
2.醫療器材/體外診斷藥物相容性調查結果通知書複印件
3.符合藥品醫療器材執法條例規定的文件（如適用）
4.QMS 調查結果總結報告副本
5.QMS 調查結果報告的副本（僅當有進行現場調查的設施時）
醫療器材的包裝與標示，須包含
1.製造商的名稱和地址
2.名稱
3. 序列號或序列碼
4.重量、容量或數量等內容
5.使用期限
6.類別：高度管理醫療器材、管理醫療器材、一般醫療器材
7. 外國製造的醫療器材的名稱、國名、地址
8.經銷商的名稱和地址
9. 認證持有人的姓名
10. 維護管理醫療設備的事實
11.單次使用的器材需標註“一次性使用”一詞外，還應使用“禁止重複使用”、“僅使用一次”等明確表示一次性使用的用語，只有符號是不允許的。
12. 使用方法及其他必要的使用和處理注意事項
13. 維護檢查相關事項
14. 厚生勞動省令規定的事項
15. 禁止
・可能是虛假或誤導的事項
・未經批准的適應症、效果或性能
・對健康和衛生有危險的用法、用量或使用期限
16.醫療器材製造和銷售許可證號+16位項目特定編號，例如從000001開始按製造和銷售通知順序的序列號要數。
*必需在容器包裝上以日文標示。
No. Foreign manufacturers and do not have a physical company in Japan, they can entrust a Marketing Authorization Holder (MAH) / Designated Marketing Authorization Holder (DMAH) to do so.
Marketing Authorization Holder (MAH)
1. MAH is the applicant, responsible for product registration, and is the owner of product approval/certification.
2. When a supplementary application or an approved/certified transfer application needs to be submitted, the MAH may submit such application within its purview, without the need to obtain the signature of the foreign manufacturer, as the MAH is the product owner.
Designated Marketing Authorization Holder (DMAH)
1. The foreign manufacturer is the applicant, DMAH is the applicant, and the foreign manufacturer is the owner of the product approval/certification.
2. During and after the product registration, DMAH acts as the representative of the foreign manufacturer, and the product registration application is submitted through DMAH, but requires the signature of the foreign manufacturer.
3. When a supplementary application or an approved/certified transfer application needs to be submitted, the signature of the representative of the foreign manufacturer is required even though the application is submitted through DMAH.
Eligibility
The Marketing Authorization Holder (MAH) and the Designated Marketing Authorization Holder (DMAH) must be a local entity in Japan with a manufacturing and sales license.
Product Licensing
It is necessary to carry out product licensing and obtain certification according to the grade and classification of medical devices.
1. Class 1: General medical equipment. A premarket registration application must be submitted to the PMDA. The application is a notification document, and PMDA will not make any review opinion.
2. Class 2: Designated and Specially Controlled Medical Devices. Products need to be certified by a third-party registered certification body (RCB) authorized by the Ministry of Health, Labour and Welfare and approved by PMDA.
3. Class 3: Specially highly regulated medical equipment. Reviewed by a third-party registered certification body (RCB) or PMDA authorized by the Ministry of Health, Labour and Welfare.
4. Class 4: Highly regulated medical equipment. Must be reviewed by the PMDA and approved by the MHLW.
*All submitted documents must be in Japanese.
Submit QMS (Quality Management System) information: Applicants will be informed of the survey method (on-site or written survey) for each facility.
1. Affidavit
2. Survey Facility Summary: Only information pertaining to an item for which the applicant has been approved (certified) or has submitted a manufacturing and sales notification will be accepted.
．Equipment name, facility location, number
．Number of employees (including part-time employees), total number of employees, manpower manufacturing department
．Number of pieces manufactured (manufactured and sold),
．Names, locations, processes, facility names, locations, processes of significant suppliers
．Describe a facility that supplies purchased product or a facility that outsources processes that have a particular impact on the effectiveness and safety of the product．
3. List of sub-items: Medical Device Control Code (JMDN) according to the application
4. Affidavit of Quality Management
5. Application
． Applicant’s name
． Person in charge
． Department name
． Telephone
． Fax
． Project name
． Facility name
． Manufacturers
． Design
． Primary assembly
． Sterilize
． Shipping
The following documents will be mailed to the applicant if the survey of all facilities related to the compliance survey application is completed and the results of the survey are satisfactory.
1. Certificate of Qualification or Certificate of Additional Results
2. A copy of the notification letter of the compatibility investigation of medical devices/in vitro diagnostic drugs
3. Documents in compliance with the regulations on drug and medical device law enforcement (if applicable)
4. A copy of the QMS findings summary report
5. A copy of the QMS survey results report (only if there are facilities to conduct on-site surveys)
Packaging and labelling of medical devices must include
1. Manufacturer’s name and address
2. Name
3. Serial number or serial code
4. Contents such as weight, capacity or quantity
5. Term of use
6. Category: highly managed medical equipment, managed medical equipment, general medical equipment
7. Name, country name, address of foreign-made medical device
8. Distributor’s name and address
9. The name of the certification holder
10. Facts about maintaining and managing medical equipment
11. In addition to the word “single-use”, the single-use equipment should be marked with the words “repeated use prohibited”, “only used once” and other terms that clearly indicate single-use use. Only symbols are not allowed.
12. How to use and other necessary precautions for use and handling
13. Items related to maintenance and inspection
14. Matters stipulated by ordinance of the Ministry of Health, Labour and Welfare
15. Prohibited
・ Matters that may be false or misleading
・Unapproved indications, effects or properties
・Usage, dosage or duration of use that is dangerous to health and hygiene
16. Medical device manufacturing and sales license number + 16-digit item-specific number, such as serial numbers starting from 000001 in the order of manufacturing and sales notification.
*Must be marked in Japanese on the container and packaging.
【參考連結】
https://www.pmda.go.jp/review-services/gmp-qms-gctp/qms/0003.html
https://www.std.pmda.go.jp/stdDB/index_en.html
HLF-JP-55
Evershine RD：
TÜV
https://www.tuvsud.com/en
Emergo
DQS
https://www.dqsglobal.com/jp-jp/
HLF-JP-60
經過核准登記的醫療器材，進口到日本要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved medical devices into Japan? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
醫療器材等作為企業進口，除非厚生勞動省核准的製造和銷售，或已獲得製造業務許可或註冊的者方可進口。
進口報關時，需向海關證明這些受管制貨物已根據《藥品和醫療器材法》獲得批准和批准。
提供：
1. 製造販賣業許可證（同生產許可證或同生產企業登記證）
2. 製造販賣業許可批准文件（同證或同通知書）複印件一份
海關
1.海關分類號（HS編碼）
．診斷設備 (HS9018)
．氧氣吸入器 (HS9019.20)
．骨科設備 (HS9021)
．X 射線設備 (HS9022)
．溫度計和非接觸式電子溫度計 (HS9025)
．醫療設備的海關分類根據其特性和功能而有所不同，建議提供實際進口產品的詳細信息，並提前向海關諮詢處諮詢。
2.進口規定
醫療器材受《藥品和醫療器材質量、有效性和安全保證法》（原藥事法，以下簡稱《藥品和醫療器材法》）的規定約束，除非獲得本法的許可。法律已獲得，不能進口。
海關應確認的具體文件和事項
1. 製造商/分銷商或製造商作為企業進口(以銷售或製造為目的進口)
2. 符合法令規範、獲准
3. 進口商製造販賣業許可證（複印件）並經批准
*各地縣政府申請
4. 報關單內容：
．採購表格（發票）
．提貨單或海運單（空運單）
．票價說明
．保險費報表
．其他法律的許可/批准證明書（如果貨物需要根據海關相關法律（如植物保護法）以外的法律許可/批准）
．優惠原產地證書（適用優惠關稅時）
．免稅聲明（申請免稅時）
銷售前通知
產品上市前，需通知縣政府，提交醫療器器材上市許可申請，上市許可持有人 (MAH) /指定上市許可持有人 (DMAH)代為辦理。
1. 分類
2. 名稱/通用名稱
3. 品牌
4. 使用目的或效果
5. 形狀、結構和原理
6.原料
7.性能和安全標準
8.如何使用
9.儲存方式及有效期
10.生產方式
11.製造和銷售項目的工廠名稱
12.註冊號
備註：
1 紙張尺寸應為日本工業標準 A4。
2 提交本申請表正本一份，副本兩份。
3 字用墨、墨等，用楷書書寫。
4 印花稅票應僅貼在原件上，不得加蓋郵戳。
5.如果製造/銷售的項目是從國外進口的醫療器械，輸入該項目的進口目的地國名、製造商/分銷商或製造商的名稱、進口時的銷售名稱製造方法欄中的目的地。
7.在儲存方式和有效期欄中，僅描述除非使用特定的儲存方式，否則質量難以保證的醫療器械，或需要特定有效期的醫療器械。
8. 如果有多個製造工廠，請在要製造和銷售的項目的製造工廠欄中分別描述。
Medical equipment, etc. can be imported as a business, unless the Ministry of Health, Labour and Welfare has approved the manufacture and sale, or those who have obtained the manufacturing business license or registration. At the time of import declaration, it is necessary to prove to customs that these regulated goods have been approved and approved under the Drugs and Medical Devices Act.
Supply:
1. Manufacturing and sales license (same as the production license or the same as the production enterprise registration certificate)
2. A copy of the approval document for the manufacturing and sales business license (same certificate or the same notice)
Customs
1. Customs classification number (HS code)
． Diagnostic Equipment (HS9018)
． Oxygen Inhaler (HS9019．20)
． Orthopedic Equipment (HS9021)
． X-ray equipment (HS9022)
． Thermometers and Non-Contact Electronic Thermometers (HS9025)
． The customs classification of medical equipment varies according to its characteristics and functions, it is recommended to provide detailed information on the actual imported product and consult the customs enquiry in advance．
2. Import regulations
Medical devices are subject to the provisions of the Law on Assurance of Quality, Effectiveness and Safety of Medicines and Medical Devices (former Pharmaceutical Affairs Law, hereinafter referred to as the “Drugs and Medical Devices Law”) unless permitted by this Law. The law has been obtained and cannot be imported.
Specific documents and matters that the customs should confirm
1. Manufacturer/distributor or manufacturer imported as a business (imported for sale or manufacture)
2. Comply with laws and regulations, approved
3. Importer’s manufacturing and sales license (copy) and approved
*Apply to county governments
4. Contents of customs declaration:
． Purchase Form (Invoice)
． Bill of Lading or Sea Waybill (Air Waybill)
． Fare Description
． Premium Statement
． Certificate of license/approval from other laws (if the goods need to be licensed/approved under laws other than customs-related laws (e．g． plant protection law))
． Preferential Certificate of Origin (when preferential tariffs apply)
． Tax exemption declaration (when applying for tax exemption)
Pre-Sale Notice
Before the product goes into the market, the county government needs to be notified, and the application for the marketing authorization of the medical device shall be submitted, and the marketing authorization holder (MAH)/designated marketing authorization holder (DMAH) shall handle it on their behalf.
1. Classification
2. Name/Common Name
3. Brand
4. Purpose or effect of use
5. Shape, structure and principle
6. Raw materials
7. Performance and Safety Standards
8. How to use
9. Storage method and validity period
10. Production methods
11. The name of the factory that manufactures and sells the item
12. Registration number
Remark:
1 The paper size should be JIS A4.
2 Submit one original and two copies of this application form.
3 characters are written in regular script with ink, ink, etc.
4 Tax stamps shall be affixed to the original only and shall not be postmarked.
5. If the item manufactured/sold is a medical device imported from abroad, enter the country name of the item’s import destination, the name of the manufacturer/distributor or manufacturer, the sales name at the time of import and the destination in the manufacturing method column .
7. In the column of storage method and expiration date, only describe medical devices whose quality is difficult to guarantee unless a specific storage method is used, or medical devices that require a specific expiration date.
8. If there are multiple manufacturing plants, describe them separately in the Manufacturing Plant column of the item to be manufactured and sold.
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000066199.html
https://www.customs.go.jp/tetsuzuki/c-answer/imtsukan/1805_jr.htm
HLF-JP-70
日本醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.第一級：一般醫療器材。產品採自我聲明，不需要批准。
2.第二級：指定和特別管制醫療器材。產品需要經過厚生勞動省授權的第三方註冊認證機構(RCB)的認證且經PMDA 批准(日本當地)。
3.第三級：特別高度管制醫療器材，由厚生勞動省授權的第三方註冊認證機構(RCB)或 PMDA 審查。(日本當地)
4.第四級：高度管制醫療器材，必須由 PMDA 審查並由 MHLW 批准。(日本當地)
依據產品項目不同，由醫療器材認證標準規定分別檢驗資料：
檢驗機構：RCB認證機構(第二、三級)
網頁：https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
檢驗機構：PMDA(第三、四級)
網頁：https://www.dwap.pmda.go.jp/dwap_shinpou/login/dwpMWK0010g.action
1. Class 1: general medical equipment.
‧Products are self-declared and do not require approval, but a sales notification is required before sale.
2. Class 2: Designated and specially controlled medical devices.
‧Products need to be certified by a third-party Registration Certification Body (RCB) authorized by the Ministry of Health, Labour and Welfare and approved by PMDA.
3. Class 3: Specially highly regulated medical equipment.
‧Reviewed by a third-party Registration Certification Body (RCB) or PMDA authorized by the Ministry of Health, Labour and Welfare.
4. Class 4: Highly regulated medical equipment.
‧Must be reviewed by the PMDA and approved by the MHLW
According to different product items, the inspection materials are separately stipulated by the medical device certification standard:
Inspection organization:
RCB certificated (Class 2 and 3)
URL: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
PMDA (Class 3 and 4)
URL:https://www.dwap.pmda.go.jp/dwap_shinpou/login/dwpMWK0010g.action
【參考連結】
https://www.std.pmda.go.jp/stdDB/index_sum_absframe.html
HLF-JP-75
日本醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？Evershine RD：
第一級產品不須批准，第二級至第四級產品皆需要在日本當地接受檢驗。
檢驗機構：RCB(第二、三級)
網頁：https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
檢驗機構：PMDA(第三、四級)
網頁：https://www.dwap.pmda.go.jp/dwap_shinpou/login/dwpMWK0010g.action
HLF-JP-77
請問在日本有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？Evershine RD：
TÜV https://www.tuvsud.com/en
Emergo https://www.emergobyul.com/
DQS https://www.dqsglobal.com/jp-jp/
BSI https://www.bsigroup.com/ja-JP/
SGS https://www.sgsgroup.jp/
COSMOS https://www.safetyweb.co.jp/zh/
JQA https://www.jqa.jp/
Nanotech Spindler Co. https://nanotecspindler.com/
JET https://www.jet.or.jp/
JAAME https://www.jaame.or.jp/
AICS http://www.aics-inc.jp/
*每間公司可以認證的醫療器材不同，需參照日本主管機關規範
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
HLF-JP-80
外國子公司進口醫療器材後，如果委託日本的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports medical devices and entrusts a distributor in Japan to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
需要。公司登記時需要設有規定人員，並於銷售前根據欲販售的醫療器材級別取得醫療器材製造販賣業許可證。
當醫療器材有安全疑慮，發現懷疑有副作用或傳染病的病例時，依據藥品、醫療器材安全保障法，製造商和分銷商有義務向PMDA 報告，申報方法等因項目的種類而異，參閱IKW 網站：
https://ikw.info.pmda.go.jp/fuguai/kiki-new.html
附表的申報方式有兩種：上傳到受理現場、EDI發送、紙本申報。
It is necessary to have prescribed personnel, and obtain a medical device manufacturing and sales license according to the level of the medical device to be sold before sales.
When there are concerns about the safety of medical equipment and cases of suspected side effects or infectious diseases are found, according to the Drugs and Medical Equipment Safety and Security Act, manufacturers and distributors are obliged to report to PMDA. The reporting method varies depending on the type of item, see IKW website:
https://ikw.info.pmda.go.jp/fuguai/kiki-new.html
There are two ways to declare the attached form: uploading to the acceptance site, sending by EDI, and paper declaration.
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html
https://www.pmda.go.jp/index.html
HLF-JP-85
Evershine RD：
Atsumi & Sakai
Support Gyoseishoshi Law Firm
https://gztoworld.com/
Foley & Lardner LLP
https://www.foley.com/en
Email：tyo4ww@evershinecpa.com
或
日本永輝BPO有限公司 -Evershine.jp
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
丘玲恵（Kyu Reike）日本籍来自台灣
王礼芳（Lily Wang）日本永居来自福建
或
林幸穗 Anny Lin 協理
手機：+886-937-606-272
skype: annylin8008
wechat: annylin8008
電話：+886-2-2717-0515 分機:110
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