日本医疗器材登记法规问题集

日本东京与臺湾同事携手协同爲您服务: 安排日本DMAH (Designated Marketing Authorization Holder); 外国製造商在日本註册登记 (FMR);品质管理系统 (MHLW MO169)稽核;上市前註册/认证/审批 (Marketing approval，製造贩売承认)。

日本DMAH申请相关问答

Email：tyo4ww@evershinecpa.com

或
日本永辉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）日本籍来自台湾
王礼芳（Lily Wang）日本永居来自福建
或

联络人: 林幸穗  Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

各国医疗器材登记法规问答集

HLF-JP-10
请问日本对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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，医疗器材被定义为具有明确定义的结构、使用方法、效果和性能的经批准的医疗产品，其使用目的是“诊断、治疗或预防疾病”或“影响人体的结构或功能”。

医疗器材受厚生劳动省 (MHLW)和药品和医疗器材局 (PMDA)监管。
MHLW负责法律框架的管理和监督，PMDA是一个独立机构，与厚生劳动省一起评估医疗器材的安全性、有效性，以及对医疗器材的上市许可申请进行科学审查，监测其上市后的安全性，按风险由低至高分类，每个设备都会根据其对人体的特定风险进行审查，以避免出现问题。
1.第一级：一般医疗器材。
‧产品採自我声明，不需要批准，但销售前需要销售通知。

2.第二级：指定和特别管制医疗器材。
‧产品需要经过厚生劳动省授权的第三方註册认证机构(RCB)的认证且经PMDA 批准。

3.第三级：特别高度管制医疗器材。
‧由厚生劳动省授权的第三方註册认证机构(RCB)或 PMDA 审查。

4.第四级：高度管制医疗器材。
‧必须由 PMDA 审查并由 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.

【参考连结】
https://www.pmda.go.jp/review-services/drug-reviews/0001.html
https://www.std.pmda.go.jp/stdDB/index_en.html

HLF-JP-20
外国公司要到日本销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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。于公司登记时需要设有规定人员，并于销售前根据欲贩售的医疗器材级别取得医疗器材製造贩卖业许可证。
1.第一级：第三种医疗器材製造贩卖业许可证。
2.第二级：第二种医疗器材製造贩卖业许可证。
3.第三级：第一种医疗器材製造贩卖业许可证。
4.第四级：第一种医疗器材製造贩卖业许可证。

欲取得医疗器材製造贩卖业许可证之企业需要设有规定之人员

1. 统筹製造贩卖负责人1名：
依据医疗器材级别、分类不同，所需负责人的资格条件如下。
第一级
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一专业课程。
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一学科后，从事医药品或医疗器材的品质管理或安全管理等方面之业务三年或以上。
第二、三、四级：
．大学或高等专业学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一专业课程。
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一学科后，从事医药品或医疗器材的品质管理或安全管理等方面之业务三年或以上。
．从事医药品或医疗器材的品质管理或安全管理等方面之业务五年或以上，且参加并修得厚生劳动省开办的讲习。

2. 国内品质业务运营负责人1名：
主要负责医疗器材的品质管理，应符合以下条件

．具备妥善处理医疗器材品质保证业务能力
．具有3年以上从事品质保证的相关经验
．必须是品质保证部门负责人
．医疗器材销售部门的员工不得担任
．管理产品的良好质量规范 (GQP)

3. 安全管理负责人1名：
负责蒐集并处理安全管理信息，建立安全确保措施、实施措施，应符合以下条件

．必须是安全管理统筹部门负责人(限申请第一种医疗器材製造贩卖业许可证)
．具有3年以上从事医疗器材安全管理的相关经验(限申请第一种医疗器材製造贩卖业许可证)
．具备妥善处理医疗器材安全管理业务能力
．医疗器材的安全管理工作与其他方面的安全管理工作不冲突
．医疗器材销售相关部门的员工不得担任
．执行良好警戒实践 (GVP)

申请资料：

1.申请书(个人/法人)
．从业者编码
．姓名/法人名称
．地址/法人登陆地址
．事务所名称
．事务所地址
．相关负责人身份讯息
2.法人登记证明书及业务分配表(如申请人为法人)
3.非大麻等成瘾者的陈述
4.统筹製造业贩卖负责人的雇佣证书
5.统筹製造业贩卖负责人的学历证明、从业年数证明书
6.事务所相关图纸
7.製造管理及品质管理体系的相关资料
8.安全管理体系的相关资料

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

【参考连结】

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
外国公司要到日本销售医疗器材，可以指派日本公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？
外国公司与营业代理人的产品责任为何?网页？

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。
于公司登记时需要设有规定人员，并于销售前根据欲贩售的医疗器材级别取得医疗器材製造贩卖业许可证。

1.第一级：第三种医疗器材製造贩卖业许可证。
2.第二级：第二种医疗器材製造贩卖业许可证。
3.第三级：第一种医疗器材製造贩卖业许可证。
4.第四级：第一种医疗器材製造贩卖业许可证。

欲取得医疗器材製造贩卖业许可证之企业需要设有规定之人员

1. 统筹製造贩卖负责人1名：
依据医疗器材级别、分类不同，所需负责人的资格条件如下。

第一级
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一专业课程。
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一学科后，从事医药品或医疗器材的品质管理或安全管理等方面之业务三年或以上。

第二、三、四级：
．大学或高等专业学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一专业课程。
．高中或同等以上学校修得物理学、化学、生物学、工学、讯号学、金属学、电学、机械学、医药学、牙齿医学中任一学科后，从事医药品或医疗器材的品质管理或安全管理等方面之业务三年或以上。
．从事医药品或医疗器材的品质管理或安全管理等方面之业务五年或以上，且参加并修得厚生劳动省开办的讲习。

2. 国内品质业务运营负责人1名：
主要负责医疗器材的品质管理，应符合以下条件
．具备妥善处理医疗器材品质保证业务能力
．具有3年以上从事品质保证的相关经验
．必须是品质保证部门负责人
．医疗器材销售部门的员工不得担任
．管理产品的良好质量规范 (GQP)

3. 安全管理负责人1名：
负责蒐集并处理安全管理信息，建立安全确保措施、实施措施，应符合以下条件

．必须是安全管理统筹部门负责人(限申请第一种医疗器材製造贩卖业许可证)
．具有3年以上从事医疗器材安全管理的相关经验(限申请第一种医疗器材製造贩卖业许可证)
．具备妥善处理医疗器材安全管理业务能力
．医疗器材的安全管理工作与其他方面的安全管理工作不冲突
．医疗器材销售相关部门的员工不得担任
．执行良好警戒实践 (GVP)

申请资料：

1.申请书(个人/法人)
．从业者编码
．姓名/法人名称
．地址/法人登陆地址
．事务所名称
．事务所地址
．相关负责人身份讯息

2.法人登记证明书及业务分配表(如申请人为法人)
3.非大麻等成瘾者的陈述
4.统筹製造业贩卖负责人的雇佣证书
5.统筹製造业贩卖负责人的学历证明、从业年数证明书
6.事务所相关图纸
7.製造管理及品质管理体系的相关资料
8.安全管理体系的相关资料
当医疗器材有安全疑虑，发现怀疑有副作用或传染病的病例时，依据药品、医疗器材安全保障法，製造商和分销商有义务向PMDA 报告，申报方法等因项目的种类而异，参阅IKW 网站：

https://ikw.info.pmda.go.jp/fuguai/kiki-new.html

附表的申报方式有两种：上传到受理现场、EDI发送、纸本申报。

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.

【参考连结】

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
外国公司销售到日本医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？

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。製造商须完成产品许可，如为外国製造商且在日本无实体公司，可以委託上市许可持有人 (MAH) /指定上市许可持有人 (DMAH)代为办理。

上市许可持有人 (MAH)

1.由MAH担任申请人，负责产品註册，且为产品批准/认证的所有者。
2.当需要提交补充申请或批准/认证的转让申请时，MAH可以在其权限范围内提交此类申请，不需要获得外国製造商的签名，因为 MAH 是产品所有者。

指定上市许可持有人 (DMAH)

1. 由外国製造商担任申请人，DMAH代为申请，外国製造商为产品批准/认证的所有者。
2. 在产品註册期间和之后，DMAH 充当外国製造商的代表，产品註册申请透过DMAH提交，但需要外国製造商签字。
3. 当需要提交补充申请或批准/认证的转让申请时，儘管申请是通过DMAH提交的，但仍需要外国製造商代表的签名。

资格
上市许可持有人 (MAH)、指定上市许可持有人 (DMAH)须为在日本当地的实体公司，并取得製造贩卖业许可正。

产品许可
需依照医疗器材的级别及分类进行产品许可，取得认证。
1.第一级：一般医疗器材。必须向PMDA提交一份上市前註册申请。申请为通告性文件，PMDA不会做出任何审查意见。
2.第二级：指定和特别管制医疗器材。产品需要经过厚生劳动省授权的第三方註册认证机构(RCB)的认证且经PMDA 批准。
3.第三级：特别高度管制医疗器材。由厚生劳动省授权的第三方註册认证机构(RCB)或 PMDA 审查。
4.第四级：高度管制医疗器材。必须由 PMDA 审查并由 MHLW 批准。
*所有提交文件必须是日文。

提交 QMS（质量管理体系）资料：
将通知申请人每个设施的调查方法（现场调查或书面调查）。

1. 宣誓书
2. 调查设施概要：
只接受与申请者获得批准（认证）或已提交製造和销售通知的项目有关的信息。

．设备名称、设施位置、编号
．员工人数（包括兼职员工）、员工总数 、人力製造部
．製造（製造和销售）件数、
．重要供应商的名称、地点、流程、设施名称、位置、过程
．描述有供应採购产品的设施或外包过程的设施，这对产品的有效性和安全性有特殊影响。

3. 子项目清单：依据申请的医疗器材对照编码(JMDN)
4. 品质管理宣誓书
5. 申请书
．申请人名称
．负责人姓名
．所属部门名称
．电话
．传真
．项目名称
．设施名称
．製造商
．设计
．主要组装
．灭菌
．出货

如果与符合性调查申请相关的所有设施的调查完成并且调查结果符合要求，将向申请人邮寄以下文件。

1.合格证书或附加结果证书
2.医疗器材/体外诊断药物相容性调查结果通知书複印件
3.符合药品医疗器材执法条例规定的文件（如适用）
4.QMS 调查结果总结报告副本
5.QMS 调查结果报告的副本（仅当有进行现场调查的设施时）

医疗器材的包装与标示，须包含

1.製造商的名称和地址
2.名称
3. 序列号或序列码
4.重量、容量或数量等内容
5.使用期限
6.类别：高度管理医疗器材、管理医疗器材、一般医疗器材
7. 外国製造的医疗器材的名称、国名、地址
8.经销商的名称和地址
9. 认证持有人的姓名
10. 维护管理医疗设备的事实
11.单次使用的器材需标註“一次性使用”一词外，还应使用“禁止重複使用”、“仅使用一次”等明确表示一次性使用的用语，只有符号是不允许的。
12. 使用方法及其他必要的使用和处理注意事项
13. 维护检查相关事项
14. 厚生劳动省令规定的事项
15. 禁止
・可能是虚假或误导的事项
・未经批准的适应症、效果或性能
・对健康和卫生有危险的用法、用量或使用期限
16.医疗器材製造和销售许可证号+16位项目特定编号，例如从000001开始按製造和销售通知顺序的序列号要数。

*必需在容器包装上以日文标示。

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.

【参考连结】

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
外国公司可以用自己名义申请办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？

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。
外国製造商若在日本无实体公司，须委託上市许可持有人 (MAH) /指定上市许可持有人 (DMAH)代为办理。
上市许可持有人 (MAH)

1.由MAH担任申请人，负责产品註册，且为产品批准/认证的所有者。

2.当需要提交补充申请或批准/认证的转让申请时，MAH可以在其权限范围内提交此类申请，不需要获得外国製造商的签名，因为 MAH 是产品所有者。

指定上市许可持有人 (DMAH)

1. 由外国製造商担任申请人，DMAH代为申请，外国製造商为产品批准/认证的所有者。

2. 在产品註册期间和之后，DMAH 充当外国製造商的代表，产品註册申请透过DMAH提交，但需要外国製造商签字。

3. 当需要提交补充申请或批准/认证的转让申请时，儘管申请是通过DMAH提交的，但仍需要外国製造商代表的签名。

资格

上市许可持有人 (MAH)、指定上市许可持有人 (DMAH)须为在日本当地的实体公司，并取得製造贩卖业许可正。

产品许可

需依照医疗器材的级别及分类进行产品许可，取得认证。

1.第一级：一般医疗器材。必须向PMDA提交一份上市前註册申请。申请为通告性文件，PMDA不会做出任何审查意见。

2.第二级：指定和特别管制医疗器材。产品需要经过厚生劳动省授权的第三方註册认证机构(RCB)的认证且经PMDA 批准。

3.第三级：特别高度管制医疗器材。由厚生劳动省授权的第三方註册认证机构(RCB)或 PMDA 审查。

4.第四级：高度管制医疗器材。必须由 PMDA 审查并由 MHLW 批准。

*所有提交文件必须是日文。

提交 QMS（质量管理体系）资料：
将通知申请人每个设施的调查方法（现场调查或书面调查）。

1. 宣誓书
2. 调查设施概要：只接受与申请者获得批准（认证）或已提交製造和销售通知的项目有关的信息。
．设备名称、设施位置、编号
．员工人数（包括兼职员工）、员工总数 、人力製造部
．製造（製造和销售）件数、
．重要供应商的名称、地点、流程、设施名称、位置、过程
．描述有供应採购产品的设施或外包过程的设施，这对产品的有效性和安全性有特殊影响。
3. 子项目清单：依据申请的医疗器材对照编码(JMDN)
4. 品质管理宣誓书
5. 申请书
．申请人名称
．负责人姓名
．所属部门名称
．电话
．传真
．项目名称
．设施名称
．製造商
．设计
．主要组装
．灭菌
．出货

如果与符合性调查申请相关的所有设施的调查完成并且调查结果符合要求，将向申请人邮寄以下文件。

1.合格证书或附加结果证书

2.医疗器材/体外诊断药物相容性调查结果通知书複印件

3.符合药品医疗器材执法条例规定的文件（如适用）

4.QMS 调查结果总结报告副本

5.QMS 调查结果报告的副本（仅当有进行现场调查的设施时）

医疗器材的包装与标示，须包含

1.製造商的名称和地址

2.名称

3. 序列号或序列码

4.重量、容量或数量等内容

5.使用期限

6.类别：高度管理医疗器材、管理医疗器材、一般医疗器材

7. 外国製造的医疗器材的名称、国名、地址

8.经销商的名称和地址

9. 认证持有人的姓名

10. 维护管理医疗设备的事实

11.单次使用的器材需标註“一次性使用”一词外，还应使用“禁止重複使用”、“仅使用一次”等明确表示一次性使用的用语，只有符号是不允许的。

12. 使用方法及其他必要的使用和处理注意事项

13. 维护检查相关事项

14. 厚生劳动省令规定的事项

15. 禁止

・可能是虚假或误导的事项

・未经批准的适应症、效果或性能

・对健康和卫生有危险的用法、用量或使用期限

16.医疗器材製造和销售许可证号+16位项目特定编号，例如从000001开始按製造和销售通知顺序的序列号要数。

*必需在容器包装上以日文标示。

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.

【参考连结】

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

https://www.emergobyul.com/

DQS

https://www.dqsglobal.com/jp-jp/

HLF-JP-60
经过核准登记的医疗器材，进口到日本要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：

医疗器材等作为企业进口，除非厚生劳动省核准的製造和销售，或已获得製造业务许可或註册的者方可进口。
进口报关时，需向海关证明这些受管制货物已根据《药品和医疗器材法》获得批准和批准。

提供：

1. 製造贩卖业许可证（同生产许可证或同生产企业登记证）
2. 製造贩卖业许可批准文件（同证或同通知书）複印件一份

海关

1.海关分类号（HS编码）
．诊断设备 (HS9018)
．氧气吸入器 (HS9019.20)
．骨科设备 (HS9021)
．X 射线设备 (HS9022)
．温度计和非接触式电子温度计 (HS9025)
．医疗设备的海关分类根据其特性和功能而有所不同，建议提供实际进口产品的详细信息，并提前向海关谘询处谘询。

2.进口规定

医疗器材受《药品和医疗器材质量、有效性和安全保证法》（原药事法，以下简称《药品和医疗器材法》）的规定约束，除非获得本法的许可。法律已获得，不能进口。

海关应确认的具体文件和事项

1. 製造商/分销商或製造商作为企业进口(以销售或製造为目的进口)
2. 符合法令规范、获准
3. 进口商製造贩卖业许可证（複印件）并经批准
*各地县政府申请
4. 报关单内容：
．採购表格（发票）
．提货单或海运单（空运单）
．票价说明
．保险费报表
．其他法律的许可/批准证明书（如果货物需要根据海关相关法律（如植物保护法）以外的法律许可/批准）
．优惠原产地证书（适用优惠关税时）
．免税声明（申请免税时）

销售前通知

产品上市前，需通知县政府，提交医疗器器材上市许可申请，上市许可持有人 (MAH) /指定上市许可持有人 (DMAH)代为办理。
1. 分类
2. 名称/通用名称
3. 品牌
4. 使用目的或效果
5. 形状、结构和原理
6.原料
7.性能和安全标准
8.如何使用 
9.储存方式及有效期
10.生产方式
11.製造和销售项目的工厂名称
12.註册号

备註：
1 纸张尺寸应为日本工业标准 A4。
2 提交本申请表正本一份，副本两份。
3 字用墨、墨等，用楷书书写。
4 印花税票应仅贴在原件上，不得加盖邮戳。
5.如果製造/销售的项目是从国外进口的医疗器械，输入该项目的进口目的地国名、製造商/分销商或製造商的名称、进口时的销售名称製造方法栏中的目的地。
7.在储存方式和有效期栏中，仅描述除非使用特定的储存方式，否则质量难以保证的医疗器械，或需要特定有效期的医疗器械。
8. 如果有多个製造工厂，请在要製造和销售的项目的製造工厂栏中分别描述。

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.

【参考连结】

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
日本医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：
1.第一级：一般医疗器材。产品採自我声明，不需要批准。
2.第二级：指定和特别管制医疗器材。产品需要经过厚生劳动省授权的第三方註册认证机构(RCB)的认证且经PMDA 批准(日本当地)。
3.第三级：特别高度管制医疗器材，由厚生劳动省授权的第三方註册认证机构(RCB)或 PMDA 审查。(日本当地)
4.第四级：高度管制医疗器材，必须由 PMDA 审查并由 MHLW 批准。(日本当地)

依据产品项目不同，由医疗器材认证标准规定分别检验资料：
检验机构：RCB认证机构(第二、三级)
网页：https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
检验机构：PMDA(第三、四级)
网页：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

【参考连结】
https://www.std.pmda.go.jp/stdDB/index_sum_absframe.html

HLF-JP-75

日本医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

Evershine RD：
第一级产品不须批准，第二级至第四级产品皆需要在日本当地接受检验。
检验机构：RCB(第二、三级)
网页：https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html
检验机构：PMDA(第三、四级)
网页：https://www.dwap.pmda.go.jp/dwap_shinpou/login/dwpMWK0010g.action

HLF-JP-77

请问在日本有哪些医疗器材检验机构可以提供医疗器材检验服务？网页？

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/
*每间公司可以认证的医疗器材不同，需参照日本主管机关规范
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000074863.html

HLF-JP-80
外国子公司进口医疗器材后，如果委託日本的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？

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。公司登记时需要设有规定人员，并于销售前根据欲贩售的医疗器材级别取得医疗器材製造贩卖业许可证。
当医疗器材有安全疑虑，发现怀疑有副作用或传染病的病例时，依据药品、医疗器材安全保障法，製造商和分销商有义务向PMDA 报告，申报方法等因项目的种类而异，参阅IKW 网站：

https://ikw.info.pmda.go.jp/fuguai/kiki-new.html

附表的申报方式有两种：上传到受理现场、EDI发送、纸本申报。

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.

【参考连结】

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

https://www.aplawjapan.com/en

Support Gyoseishoshi Law Firm

https://gztoworld.com/

Foley & Lardner LLP

https://www.foley.com/en

各国医疗器材登记法规问答集

Email：tyo4ww@evershinecpa.com
或
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