Japan Medical Device Regulation QA
Email: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
HLF-JP-10
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：
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
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：
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
假如需要辦理，請問日本有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
サポート行政書士法人
世田谷行政法務事務所
https://www.koda.biz/index.htm
HLF-JP-30
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：
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 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
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
假如需要辦理指派日本公司擔任營業代理人，請問日本有專業服務公司可以協助？
Evershine RD：
CMI
http://www.cmi.co.jp/index_e.html
J-SOL
https://www.j-sol-medical.co.jp/english/
MEDIARK
HLF-JP-40
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：
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
請問在日本有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
TÜV
https://www.tuvsud.com/en
Emergo
HLF-JP-50
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：
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
請問在日本有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
TÜV
https://www.tuvsud.com/en
Emergo
DQS
https://www.dqsglobal.com/jp-jp/
HLF-JP-60
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：
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
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
DQS
https://www.dqsglobal.com/jp-jp/
BSI
https://www.bsigroup.com/ja-JP/
SGS
COSMOS
https://www.safetyweb.co.jp/zh/
JQA
Nanotech Spindler Co.
JET
JAAME
AICS
*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
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：
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
japan-medical-device-regulation-qa-c
Evershine RD：
Atsumi & Sakai
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