泰國醫療器材登記法規問題集

泰國永輝BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰國籍說中文
Pay Xiao 泰國籍說英文

或
聯絡人：蘇 玉 燕  副總經理
手機：+886-928-486-835
電話：+886-2-2717-0515 分機:104
或
Email：bkk4ww@evershinecpa.com

各國醫療器材登記法規問答集

HLF-TH-10
請問泰國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 Thailand?
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：

醫療器材監管司隸屬於食品藥品監督管理局，負責控制和監督醫療器材。
醫療器材是指：
1.用於插入人體的工具、器具、機器、物體；用於實驗室內外測試的試劑、產品、軟件或任何專門用於人類或動物的其他產品。
無論製造商/所有者是單獨使用還是與其他任何東西結合使用，如下：
．診斷、預防、監測、治療、減輕或治癒疾病。
．診斷、監測、治療、減輕或治療傷害。
．檢查、替換、糾正、修改、或支持身體的解剖、生理過程
．支持或挽救生命。
．避孕或輔助生殖。
．協助或協助補償殘疾。
．用於醫療或診斷屍體標本為目的之檢查工具。
．銷毀或消毒醫療器材。
2.與第1項的一起使用的醫療器材。
3.部長指定為醫療器材的工具、器具、機器、產品或其他物品。

醫療器材分為以下 2 組：

1.用於體外診斷的醫療器材
．第一類：對人體和公共衛生具有低風險。
．第二類：對人體和公共衛生具有中等風險。
．第三類：對人體構成高風險或對公共衛生有中等風險。
．第四類：對人和公共衛生構成高風險。

2.非體外診斷的醫療器材
．第一類：風險較低的醫療器材。
．第二類：具有中等風險的低等級醫療器材。
．第三類：具有中等風險的高水平醫療器材。
．第四類：高風險醫療器材。

3.規範：
．第一類低風險醫療器材、獸用醫療器材的製造商或進口商需要預先通知。
．第二、三類中等風險醫療器材的製造商或進口商需要預先做詳細通知。
．第四類高風險醫療器材的製造商或進口商需要獲得許可。

4.分組：
醫療器材分組是將外觀相似的醫療器材放在一起並在申請中註冊。
它減少了工作量、成本，並有利於文件的準備。 可分為以下6類：
．單品
．系統
．家族
．套裝
．診斷試劑盒
．體外診斷產品

The Department of Medical Device Supervision is subordinate to the Food and Drug Administration and is responsible for controlling and supervising the operation of medical devices.
Other activities related to medical devices must contact the Food and Drug Administration and comply with regulations.

Medical equipment means:

1.Tools, utensils, machines, objects for insertion into the human body; reagents, products, software or any other product intended for use in humans or animals for testing inside or outside the laboratory.
Whether the manufacturer/owner is using it alone or in combination with anything else, as follows:
． Diagnose, prevent, monitor, treat, alleviate or cure disease.
． Diagnose, monitor, treat, mitigate or treat injury.
． Inspect, replace, correct, modify, or support anatomical, physiological processes of the body
． Support or save lives.
． Contraception or assisted reproduction.

． Assist or assist in compensating for disability.

．  Examination tools used for medical or diagnostic purposes of cadaveric specimens.

． Destroy or sterilize medical equipment.

2.Accessories for use with the medical device of item 1.

3.Tools, appliances, machines, products or other items designated by the Minister as medical devices.

Medical devices are divided into 2 groups:

1.Medical devices used for in vitro diagnosis

． Class 1: Low risk to humans and public health.

． Class II: Moderate risk to humans and public health.

． Class III: High risk to humans or moderate risk to public health.

． Class IV: High risk to human and public health.

2.Non-in vitro diagnostic medical devices

． Class 1: Low-risk medical devices.

． Class II: Low-grade medical devices with moderate risk.

． Class III: High-level medical devices with moderate risk.

． Class IV: High-risk medical devices.

3.Specifications:

． Manufacturers or importers of Class I low-risk medical devices, veterinary medical devices, require advance notice.

． Manufacturers or importers of Class II and III medium-risk medical devices need to give detailed notice in advance.

． Manufacturers or importers of Class IV high-risk medical devices need to be licensed.

4.Grouping:
Grouping of medical devices is the grouping of similar-looking medical devices together and registered in the application. It reduces effort, cost, and facilitates document preparation. It can be divided into 6 categories:
．Single
．System
．Family
．Set
．IVD Test Kit
．IVD Cluster

【參考連結】

URL:https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

https://www.fda.moph.go.th/sites/Medical/Pages/Main.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-20
外國公司要到泰國銷售醫療器材，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 Thailand, 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：

欲製造或進口醫療器材者必須註冊企業登記，申請註冊需符合以下規定：

1. 是申請設立登記證的企業主。
2. 年齡不低於二十歲。
3. 在泰國有住所。
4. 不是破產者。
5. 從未因法律規定的失信行被終審判決判處有期徒刑；或違反本法的罪行，除非在登記之日前已通過處罰兩年以上。
6. 不是精神不健全者。
7. 沒有法律規定的疾病。
8. 製造或進口的醫療器材之生產、控制、保存符合法律中規定的品質。
9. 未與被吊銷或登記證一年內未補辦的商業名稱、登記人相同或者近似。
10. 非依本法被吊銷登記證者。
11. 從未依本法被吊銷登記證，除非在申請設立登記之日起撤銷滿兩年以上。

依據規定提出申請且被許可的製造商或進口商，被視為銷售者，無需另外提交銷售許可申請。

Anyone wishing to manufacture or import medical devices must register with a business registration, and the application for registration must comply with legal rules, procedures and conditions:

1. Be the business owner applying for the establishment registration certificate.
2. Not less than twenty years old.
3. Domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts stipulated by law; or a crime against this law, unless the punishment has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no legally defined diseases.
8. The production, control and preservation of medical devices manufactured or imported conform to the quality stipulated in the law.
9. Not the same or similar to the business name or registrant whose registration certificate has not been reissued within one year.
10. Those whose registration certificate has been revoked not in accordance with this Act.
11. The registration certificate has never been revoked in accordance with this act, unless it has been revoked for more than two years from the date of application for establishment registration.

Manufacturers or importers who apply and are licensed in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

【參考連結】

https://www.dbd.go.th/dbdweb_en/index.php#

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-30
外國公司要到泰國銷售醫療器材，可以指派泰國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 Thailand, can it assign a Thailand 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：

欲銷售醫療器材者應申請銷售許可證，在獲得許可證後，可以依照法律規定的規則銷售該醫療器材。
依據規定提出申請企業登記且被許可的製造商或進口商，被視為銷售者，則無需另外提交銷售許可申請。

申請醫療器材銷售許可證條件：

1. 企業者
2. 年齡不低於二十歲。
3. 在泰國有住所。
4. 不是破產者。
5. 從未因法律規定的失信行被終審判決判處有期徒刑；或違反本法的罪行，除非在登記之日前已通過處罰兩年以上。
6. 不是精神不健全者。
7. 沒有法律規定的疾病。
8. 不得使用與處於暫停營業登記證或者暫停營業期間的營業所登記人或被許可人的業務名稱相同或者近似的商業名稱
9. 不是根據本法被吊銷執照的人
10. 從未根據本法被吊銷執照，除非許可證在提交申請之日前被吊銷兩年以上
11. 具有規定的銷售質量體系
12. 有符合規定的銷售主管
13. 法人申請許可時，經營業務的法人經理或代表必須具備上述資格。

機構註冊人、領有許可證者的責任：

1. 控制和監督醫療器材生產、進口或者銷售業務符合規定的質量。
2. 安排人員監督醫療器材的製造、進口或銷售，並監督該人員完全履行職責。
3. 製作、進口或者銷售醫療器材的報告供主管檢查並根據規定向主管機關許可人提交報告。
4. 製作醫療器材異常性能報告，或與消費者發生的不良事件，並向主管機關報告該醫療器材使用安全的改正措施，無論其在國內外是否出現異常性能或發生此類事件，均需要按照主管機關公佈的規則、程序和條件執行。
5. 提供投訴渠道，製作製造、進口或銷售有關的投訴管理系統、投訴記錄且根據部長訂定的規則、程序和條件以供主管機關檢查。
6. 提供醫療器材產地標誌、進口地、銷售地或儲存地在顯眼處。視主管機關規定的規則、程序和條件設立登記證、執照。
7. 生產地、進口地、銷售地點的顯眼地方須標示醫療器材控制者的姓名和資格。
8. 在顯眼的地方展示登記證、醫療器材銷售許可證於規定位置上。
9. 提供醫療器材質量、標準、功效和安全性的技術文件供檢驗。

Anyone wishing to sell medical devices should apply for a license, and after obtaining the license, the medical equipment can be sold in accordance with the rules prescribed by law.
Manufacturers or importers who apply and are licensed of business registration in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

Conditions for applying for a medical device sales license:

1. Entrepreneur
2. Not less than twenty years old.
3. Have a domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts prescribed by law; or a crime against this law, unless the penalty has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no diseases prescribed by law.
8. Not to use a business name that is the same as or similar to the business name of the registrant or licensee of the establishment that is in the period of suspension of business registration or suspension of business
9. Not a person whose license has been revoked under this Act
10. Has never had a license revoked under this Act unless the license was revoked more than two years prior to the date of filing the application
11. Have a prescribed sales quality system
12. Have a qualified sales executive
13. When a legal person applies for a license, the manager or representative of the legal person operating the business must have the above qualifications.

Responsibilities of Institutional Registrants and Licensees:

1. Control and supervise the quality of medical equipment production, import or sales.
2. Assign a person to supervise the manufacture, import or sale of medical equipment and supervise that person to perform their duties fully.
3. The report on the production, import or sale of medical equipment is to be inspected by the competent authority and the report shall be submitted to the competent authority licensor according to regulations.
4. Make a report on abnormal performance of medical devices or adverse events with consumers, and report to the competent authority the corrective measures for the safety of the use of the medical device, regardless of whether abnormal performance or such events occur at home and abroad The rules, procedures and conditions published by the competent authority are enforced.
5. To provide channels for complaints, to make a complaint management system related to manufacture, import or sale, record complaints and make them available for inspection by the competent authorities in accordance with the rules, procedures and conditions established by the Minister.
6. Provide the medical device’s place of origin, import, sale or storage in a conspicuous place. Registration certificates and licenses are established in accordance with the rules, procedures and conditions prescribed by the competent authority.
7. The name and qualifications of the controller of the medical device must be marked in a conspicuous place at the place of production, import and sale.
8. Display the registration certificate and medical equipment sales license in a conspicuous place in the specified position.
9. Provide technical documentation of medical device quality, standard, efficacy and safety for inspection.

【參考連結】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-40
外國公司銷售到泰國醫療器材本身，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？可允許的語文除了泰文外，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 Thailand?
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 Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

需要。依照醫療器材風險分類向食品藥品監督管理局申請產品註冊，獲得銷售授權：以電子方式提交申請直至完成許可程序，獲得製造/進口醫療器材銷售證書。

1.第一類低風險醫療器材、獸用醫療器材。

．製造/進口企業註冊號

．經營委託書

．醫療器材名稱、標籤、產品規格文件

．外國註冊的歷史文件

．生產或進口醫療器材的無菌試驗證明文件

．生產或進口醫療器材用於測量、測試或校準的文件

．製造商或產品所有人出具的產品合格證書

．產品所有人代理進口申請的委託書

2.第二、三類中等風險醫療器材

．製造/進口企業註冊號

．經營委託書

．醫療器材名稱、標籤、產品規格、製造內容及產品所有者等詳細文件

．醫療器材安全和性能的文件

．總結設計驗證和確認的文件

．風險分析的文件

．使用後產生的廢棄物其銷毀、變質或者消除方法的文件

．質量證書

．製造商或產品所有者製造方式、使用目的、說明、包裝、標籤

．製造商或產品所有人出具的產品合格證書

．分銷製造商或產品所有者的銷售歷史證明

．產品製造商或所有者證明安全的證書

．國外食品藥品監督管理局許可的證明

．代理進口申請的委託書

3.第四類高風險醫療器材

．製造/進口企業註冊號

．經營委託書

．醫療器材名稱、標籤、產品規格、製造內容及產品所有者等詳細文件

．醫療器材安全和性能的文件

．總結設計驗證和確認的文件

．風險分析的文件

．使用後產生的廢棄物其銷毀、變質或者消除方法的文件

．質量證書

．製造商或產品所有者製造方式、使用目的、說明、包裝、標籤

．製造商或產品所有人出具的產品合格證書

．分銷製造商或產品所有者的銷售歷史證明

．產品製造商或所有者證明安全的證書

．國外食品藥品監督管理局許可的證明

．代理進口申請的委託書

醫療器材標籤規範：

1. 需要貼上國外和國內製造商的標籤、和符合公共衛生部通知的標籤
2. 包裝盒標籤(貼在產品盒上的標籤)：需標示型號名稱

．家庭使用：根據法律規定的主題以泰語編寫。

．專業用途：根據法律規定的主題以英語或泰語編寫。

3. 醫療器材詳細資訊需取自製造商的標籤、用戶手冊。
4. 醫療設備文件是顯示產品詳細訊息（例如設備特性）。
5. 產品包裝​​盒內應包含醫療用途、使用適應症、使用說明、警告、注意事項等說明。

Apply for product registration to the Food and Drug Administration in accordance with the medical device risk classification and obtain sales authorization: submit the application electronically until the licensing process is completed, and obtain a manufacturing/imported medical device sales certificate.

1. Class I low-risk medical equipment and veterinary medical equipment.

． Manufacturing/importing company registration number

． Business Power of Attorney

． Medical device name, label, product specification file

． Foreign registered historical documents

． Proof of sterility test for production or import of medical devices

． Documentation of the manufacture or import of medical devices for measurement, testing or calibration

． Product conformity certificate issued by the manufacturer or product owner

． Power of Attorney for the product owner to act as an agent for import application

2. Class II and III medium-risk medical devices

． Manufacturing/importing company registration number

． Business Power of Attorney

． Details of medical device name, label, product specification, manufacturing content and product owner

． Documents for Medical Device Safety and Performance

． Document summarizing design verification and validation

． Documents for Risk Analysis

． Documents on the method of destruction, deterioration or elimination of waste generated after use

． quality certificates

． How the manufacturer or product owner made it, purpose of use, directions, packaging, labeling

． Product Certificate of Conformity issued by the manufacturer or product owner

． Proof of sales history from distributor manufacturer or product owner

． Product manufacturer or owner certificate certifying safety

． Certificate of approval from foreign food and drug administrations

． Power of Attorney for Import Application

3. Class IV high-risk medical devices

． Manufacturing/importing company registration number

． Business Power of Attorney

． Detailed documents such as medical device name, label, product specification, manufacturing content and product owner

． Documentation of Medical Device Safety and Performance

． Document summarizing design verification and validation

． Risk Analysis Documents

． Documents on the method of destruction, deterioration or elimination of waste generated after use

． quality certificates

． How the manufacturer or product owner made it, purpose of use, instructions, packaging, labelling

． Product conformity certificate issued by the manufacturer or product owner

． Proof of sales history from the distributor manufacturer or product owner

． Product manufacturer or owner certificate certifying safety

． Certificate of Foreign Food and Drug Administration License

． Power of Attorney for Import Application

Device Labeling specification:

1. Labeling of foreign and domestic manufacturers, and labels in compliance with Ministry of Public Health notices
2. Box label (label attached to the product box): need to indicate the model name

． For Home Use: Written in Thai according to the subject matter required by law.

． Professional Use: Written in English or Thai depending on the subject matter required by law.

3. The detailed information of the medical device should be taken from the manufacturer’s label, user manual.
4. The medical device file is to display product details (eg device characteristics).
5. The product packaging box should contain instructions for medical use, indications for use, instructions for use, warnings, precautions, etc.

【參考連結】

https://www.fda.moph.go.th/sites/Medical/SitePages/overview_MDC_product_registration.aspx

http://www.krisdika.go.th/librarian/get?sysid=773817&ext=htm

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-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？
可允許的語文除了泰文外，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 Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

須以泰國當地公司名義申請。
欲製造或進口醫療器材者必須註冊企業登記，申請註冊需符合以下規定：

1. 是申請設立登記證的企業主。
2. 年齡不低於二十歲。
3. 在泰國有住所。
4. 不是破產者。
5. 從未因法律規定的失信行被終審判決判處有期徒刑；或違反本法的罪行，除非在登記之日前已通過處罰兩年以上。
6. 不是精神不健全者。
7. 沒有法律規定的疾病。
8. 製造或進口的醫療器材之生產、控制、保存符合法律中規定的品質。
9. 未與被吊銷或登記證一年內未補辦的商業名稱、登記人相同或者近似。
10. 非依本法被吊銷登記證者。
11. 從未依本法被吊銷登記證，除非在申請設立登記之日起撤銷滿兩年以上。

醫療器材標籤規範：

1. 需要貼上國外和國內製造商的標籤、和符合公共衛生部通知的標籤
2. 包裝盒標籤(貼在產品盒上的標籤)：需標示型號名稱

．家庭使用：根據法律規定的主題以泰語編寫。

．專業用途：根據法律規定的主題以英語或泰語編寫。

3. 醫療器材詳細資訊需取自製造商的標籤、用戶手冊。
4. 醫療設備文件是顯示產品詳細訊息（例如設備特性）。
5. 產品包裝​​盒內應包含醫療用途、使用適應症、使用說明、警告、注意事項等說明。

Anyone wishing to manufacture or import medical devices must register with a business registration, and the application for registration must comply with legal rules, procedures and conditions:

1. Be the business owner applying for the establishment registration certificate.
2. Not less than twenty years old.
3. Domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts stipulated by law; or a crime against this law, unless the punishment has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no legally defined diseases.
8. The production, control and preservation of medical devices manufactured or imported conform to the quality stipulated in the law.
9. Not the same or similar to the business name or registrant whose registration certificate has not been reissued within one year.
10. Those whose registration certificate has been revoked not in accordance with this Act.
11. The registration certificate has never been revoked in accordance with this act, unless it has been revoked for more than two years from the date of application for establishment registration.

Device Labeling specification:

1. Labeling of foreign and domestic manufacturers, and labels in compliance with Ministry of Public Health notices
2. Box label (label attached to the product box): need to indicate the model name

． For Home Use: Written in Thai according to the subject matter required by law.

． Professional Use: Written in English or Thai depending on the subject matter required by law.

3. The detailed information of the medical device should be taken from the manufacturer’s label, user manual.
4. The medical device file is to display product details (eg device characteristics).
5. The product packaging box should contain instructions for medical use, indications for use, instructions for use, warnings, precautions, etc.

【參考連結】

https://www.dbd.go.th/dbdweb_en/index.php#

https://www.fda.moph.go.th/sites/Medical/SitePages/overview_MDC_product_registration.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/risk%20classification.aspx

HLF-TH-60
經過核准登記的醫療器材，進口到泰國要檢附什麼文件？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 Thailand?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

欲銷售醫療器材者應申請銷售許可證，在獲得許可證後，可以依照法律規定的規則銷售該醫療器材。依據規定提出申請企業登記且被許可的製造商或進口商，被視為銷售者，則無需另外提交銷售許可申請。

申請醫療器材銷售許可證條件：

1. 企業者
2. 年齡不低於二十歲。
3. 在泰國有住所。
4. 不是破產者。
5. 從未因法律規定的失信行被終審判決判處有期徒刑；或違反本法的罪行，除非在登記之日前已通過處罰兩年以上。
6. 不是精神不健全者。
7. 沒有法律規定的疾病。
8. 不得使用與處於暫停營業登記證或者暫停營業期間的營業所登記人或被許可人的業務名稱相同或者近似的商業名稱9. 不是根據本法被吊銷執照的人
9. 從未根據本法被吊銷執照，除非許可證在提交申請之日前被吊銷兩年以上
10. 具有規定的銷售質量體系
11. 有符合規定的銷售主管
12. 法人申請許可時，經營業務的法人經理或代表必須具備上述資格。

醫療器材實體銷售業者註冊提供資料：

1. 承諾書
2. 請求銷售同意書(經銷商)
3. 委託書(製造商或進口商)
4. 醫療器材銷售授權書
5. 地圖(詳細描述醫療器材銷售、倉儲地點的路程)
6. 銷售及倉儲照片

．遠觀照片
．招牌
．地址
．醫療器材銷售的橙色標誌(尺寸不小於 20×70 厘米，並以白色泰文顯示不少於 3 厘米)
．醫療器材存放場所標誌的紅色標誌(尺寸不小於 20×70 厘米，並以白色泰文顯示不少於 3 厘米)
．往醫療器材銷售處的照片
．醫療器材銷售辦公室開業照片
．醫療器材銷售辦公區域內的照片
．通向醫療器材存放區的照片
．存放醫療設備的區域的標誌照片
．醫療器材儲藏室內的照片有一個存放工具的裝置(例如：貨架、托盤或冰箱等，並帶有指示牌)
．如果建築物樓層有很多，必須在每張圖片中表示所述用作銷售和儲存醫療器材的辦公室在哪一層
．可以用多張圖片來描述
．可以給額外的圖像將描述更清楚

7. 銷售醫療器材標誌的申請書
8. 醫療器材儲存設施的同意書

機構註冊人、領有許可證者的責任：

1. 控制和監督醫療器材生產、進口或者銷售業務符合規定的質量。
2. 安排人員監督醫療器材的製造、進口或銷售，並監督該人員完全履行職責。
3. 製作、進口或者銷售醫療器材的報告供主管檢查並根據規定向主管機關許可人提交報告。
4. 製作醫療器材異常性能報告，或與消費者發生的不良事件，並向主管機關報告該醫療器材使用安全的改正措施，無論其在國內外是否出現異常性能或發生此類事件，均需要按照主管機關公佈的規則、程序和條件執行。
5. 提供投訴渠道，製作製造、進口或銷售有關的投訴管理系統、投訴記錄且根據部長訂定的規則、程序和條件以供主管機關檢查。
6. 提供醫療器材產地標誌、進口地、銷售地或儲存地在顯眼處。視主管機關規定的規則、程序和條件設立登記證、執照。
7. 生產地、進口地、銷售地點的顯眼地方須標示醫療器材控制者的姓名和資格。
8. 在顯眼的地方展示登記證、醫療器材銷售許可證於規定位置上。
9. 提供醫療器材質量、標準、功效和安全性的技術文件供檢驗。

Anyone wishing to sell medical devices should apply for a license, and after obtaining the license, the medical equipment can be sold in accordance with the rules prescribed by law.
Manufacturers or importers who apply and are licensed of business registration in accordance with the regulations are considered sellers and do not need to submit a separate application for sales authorization.

Conditions for applying for a medical device sales license:

1. Entrepreneur
2. Not less than twenty years old.
3. Have a domicile in Thailand.
4. Not bankrupt.
5. Has never been sentenced to fixed-term imprisonment by a final judgment for dishonest acts prescribed by law; or a crime against this law, unless the penalty has been passed for more than two years before the date of registration.
6. Not mentally disabled.
7. There are no diseases prescribed by law.
8. Not to use a business name that is the same as or similar to the business name of the registrant or licensee of the establishment that is in the period of suspension of business registration or suspension of business 9. Not a person whose license has been revoked under this Act
9. Has never had a license revoked under this Act unless the license was revoked more than two years prior to the date of filing the application
10. Have a prescribed sales quality system
11. Have a qualified sales executive
12. When a legal person applies for a license, the manager or representative of the legal person operating the business must have the above qualifications.

Information provided for registration of medical device sales enterprises:

1. Commitment
2. Request for Sales Consent (Dealer)
3. Power of Attorney (Manufacturer or Importer)
4. Medical Device Sales Authorization
5. Map (describe in detail the distance of medical device sales and storage locations)
6. Sales and Warehousing Photos

．Photos from a distance

．Shop sign

．Address

．Orange sign for sale of medical device (dimensions not less than 20×70 cm and not less than 3 cm displayed in white Thai)

．Red sign for medical device storage place sign (dimensions not less than 20×70 cm and not less than 3 cm displayed in white Thai)

．Photo to the medical device sales office

．Medical device  sales office opening photo

．Photo inside the medical device sales office area

．photo leading to the medical device  storage area

．Photo of a sign of an area where medical device is stored

．Photo of medical device  storage room with a device for storing tools (eg: shelf, tray, or refrigerator, etc., with signage)

．If there are many floors in the building, each picture must indicate which floor of the office used for the sale and storage of medical device is located

．Can be described with multiple pictures

．Can give additional images to describe more clearly

7. Application for Sale of Medical Device Mark
8. Consent for Medical Device Storage Facility

Responsibilities of Institutional Registrants and Licensees:

1. Control and supervise the quality of medical equipment production, import or sales.
2. Assign a person to supervise the manufacture, import or sale of medical equipment and supervise that person to perform their duties fully.
3. The report on the production, import or sale of medical equipment is to be inspected by the competent authority and the report shall be submitted to the competent authority licensor according to regulations.
4. Make a report on abnormal performance of medical devices or adverse events with consumers, and report to the competent authority the corrective measures for the safety of the use of the medical device, regardless of whether abnormal performance or such events occur at home and abroad The rules, procedures and conditions published by the competent authority are enforced.
5. To provide channels for complaints, to make a complaint management system related to manufacture, import or sale, record complaints and make them available for inspection by the competent authorities in accordance with the rules, procedures and conditions established by the Minister.
6. Provide the medical device’s place of origin, import, sale or storage in a conspicuous place. Registration certificates and licenses are established in accordance with the rules, procedures and conditions prescribed by the competent authority.
7. The name and qualifications of the controller of the medical device must be marked in a conspicuous place at the place of production, import and sale.
8. Display the registration certificate and medical equipment sales license in a conspicuous place in the specified position.
9. Provide technical documentation of medical device quality, standard, efficacy and safety for inspection.

【參考連結】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

HLF-TH-70
泰國醫療器材審核機構，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：

在泰國進行醫療器材註冊需要獲得良好作業規範認證或是等同其品質系統管理認證。
良好作業規範認證所需資料：

1. 醫療器材製造企業註冊證
2. 認證醫療器材的內容

．醫療器材製造地址

．電話

．製造商

3. 認證醫療器材的範圍(泰語、英語)
4. 申請認證範圍內的員工人數、工作日、工作時間、換班次數
5. 被認證醫療器材的風險等級(1.2.3.4)
6. 各種質量體系認證(例如：國外GMP認證、ISO認證)
7. 機構內流程(全線生產+設計與開發/全線生產但不包括設計和開發/重新包裝)
8. 質量體系相關內容

．聯繫人（應代表管理層或了解組織質量體系的人）

．姓名、職位、電話、手機、電子郵件、地址

9. 承諾書：遵守依循醫療器材管制司的規定和條件設置、被設置或修改，以及繳交相關認證審核費用。

10 同意書：同意醫療器材管理部門的官員或企業審查單位隨時檢查。

11. 附上供審議的證據和文件如下：

．製造企業註冊證影本

．法人登記證

．醫療器材或質量體系的認可（如果有）

．醫療器材生產企業位置圖和內部圖1份

．醫療器材和部門關係

．製造過程簡圖及獲得認證的醫療器械材產品2套

．質量手冊

．操作規則標準或手冊1套

．監測和控制影響產品質量的環境因素

．生產和運營服務

．服務、測量程序和使用的材料

．確認過程的驗證

．產品標識及產品檢驗情況

．可追溯性

．產品存儲

．檢測儀器控制

．內部審核

．不合格品的控制

Registration of medical devices in Thailand requires certification of Good Manufacturing Practice or its equivalent in Quality System Management.
Documents required for Good Practice Certification:

1. Medical Device Manufacturing Enterprise Registration Certificate
2. Contents of certified medical devices

． Medical device manufacturing address

． Telephone

． manufacturer

3. Scope of certified medical devices (Thai, English)
4. The number of employees, working days, working hours, and shift times within the scope of the certification application
5. Risk level of certified medical devices (1.2.3.4)
6. Various quality system certifications (for example: foreign GMP certification, ISO certification)
7. In-house processes (full production + design and development/full production but excluding design and development/repackaging)
8. Contents related to quality system

． Contact (should represent management or someone with knowledge of the organization’s quality system)

． Name, title, phone, mobile, email, address

9. Commitment: To comply with the regulations and conditions of the Medical Device Control Department to set, be set or modified, and pay the relevant certification and audit fees.

10 Consent letter: Agree to inspect at any time by officials of the medical device management department or the enterprise review unit.

11. The evidence and documents attached for consideration are as follows:

． Manufacturing enterprise registration certificate copy

． Legal person registration certificate

． Approval of medical device or quality system (if any)

． 1 copy of the location map and internal map of the medical equipment manufacturer

． Medical Devices and Department Relations

． Manufacturing process diagram and 2 sets of certified medical device products

． Quality Manual

． 1 set of operating rules standard or manual

． Monitoring and Controlling Environmental Factors Affecting Product Quality

． Production and Operational Services

． Services, Measurement Procedures and Materials Used

． Validation of confirmation process

． Product identification and product inspection

． traceability

． product storage

． Testing Instrument Control

． Internal review

． Control of non-conforming products

【參考連結】

https://privus.fda.moph.go.th/index.aspx

https://www.fda.moph.go.th/sites/Medical/SitePages/Relative.aspx

HLF-TH-75
泰國醫療器材審核機構，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？

HLF-TH-80
外國子公司進口醫療器材後，如果委託泰國的經銷商銷售，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 Thailand 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：

為了保護消費者的健康和安全，當懷疑任何醫療設備質量不佳或使用上可能對健康有害時，秘書長有權責令醫療器材製造商或進口商提交證明其質量的文件或證據。
訴訟期間秘書長有權暫停生產、進口或銷售，直至證明該醫療器材質量良好，符合標準的安全性能。
當已獲知任何醫療器材的質量、標準或功效不符合許可或使用不安全可能對健康有害時，秘書長具有下列權力：

1. 以書面形式向領有許可證者發出命令，令其修正。
2. 以書面形式向製造商、進口商、銷售商或持有醫療器材使用的人發出命令，令其改進製造、進口、銷售或擁有的醫療器材。
3. 書面責令醫療器材生產企業、進口企業或者銷售企業停止生產、進口或者銷售醫療器材，或採取規定的其他相關行動。
4. 公佈醫療器材檢驗或者分析結果，並將任何違反或不遵守的行為公告社會。
5. 向生產者、進口者、銷售者或者持有人收取醫療器材，或者責令期限內將其生產、進口或者從市場上售回的醫療器材召回。

醫療器材的製造商、進口商或銷售商應對使用醫療器材造成的任何損害負責，除非能夠證明損壞是由於不可抗力造成的，或不是因為醫療器材的瑕疵引起的，或者因為受害人本身的過錯造成。
上述的損害索賠包含身體或健康受到損害而造成的精神損害，自傷者知悉損害並知道誰應承擔損害賠償責任之日起有三年追索權。

In order to protect the health and safety of consumers, the Secretary-General has the power to order the manufacturer or importer of medical devices to submit documents or evidence to prove its quality when it is suspected that any medical devices is of poor quality/performance may be harmful to health.
During the proceedings, the Secretary-General has the right to suspend the production, import or sale of the medical device until it is proved that the medical device is good quality, safe and standard in performance.

The Secretary-General has the powers to:

1. Issue a written order to the licensed person to amend.
2. Issue a written order to the manufacturer, importer, seller, or person in possession of the medical device to improve the medical device that it manufactures, imports, sells, or possesses.
3. Order in writing the medical equipment manufacturer, importer or sales enterprise to stop the production, import or sale of medical equipment, or to take other relevant actions as specified.
4. Publish the results of medical equipment inspection or analysis, and announce any violation or non-compliance to the public.
5. Collect medical equipment from producers, importers, sellers or holders, or order the recall of medical equipment produced, imported or sold from the market within the time limit.

The manufacturer, importer or seller of a medical device is liable for any damage caused by the use of the medical device, unless it can be shown that the damage was caused by force majeure, or was not caused by a defect in the medical device, or was caused by the victim’s own fault. For the damage claims mentioned above, including mental damage caused by damage to body or health, the self-injured person has a three-year recourse period after knowing the damage and knowing who should be liable for the damage.

【參考連結】

https://www.fda.moph.go.th/sites/Medical/SitePages/MDDAct.aspx

各國醫療器材登記法規問答集

泰國永輝BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰國籍說中文
Pay Xiao 泰國籍說英文

或
聯絡人：蘇 玉 燕  副總經理
手機：+886-928-486-835
電話：+886-2-2717-0515 分機:104
或
Email：bkk4ww@evershinecpa.com

永輝關係企業: 泰國永輝服務有限公司
Evershine Services (Thailand) Co., Ltd
https://bkk.evershinecpa.com
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
Bangkok Manager Paul Xiao, who speaks in both English and Thai.
M: +66-(0)852-222-197

全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

請用下列電郵與我們聯繫: HQ4TPE@evershinecpa.com

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