Thailand Medical Device Regulations QA

Email: bkk4ww@evershinecpa.com
Manager Paul, Speak Thai, English
WeChat: Paul0864580532

HLF-TH-10

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：

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

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：

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-25

假如需要辦理，請問泰國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：

PANWA

https://www.companythailand.net/

INTERLOOP

https://inlps.com/

HLF-TH-30

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：

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-35

假如需要辦理指派泰國公司擔任營業代理人，請問泰國有專業服務公司可以協助？

Evershine RD：

Atlanta Medicare

https://www.atlantamedicare.co.th/about-us/

BUC

https://bucmedi.com/About.html

HLF-TH-40

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：

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-45

請問在泰國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：

Qualtech

https://www.qualtechs.com/zh-tw/

Vize

https://vizecounselor.com/foreign-business-license-lawyer-thailand/medical-device-license/

HLF-TH-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 Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

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-55

請問在泰國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：

Qualtech

https://www.qualtechs.com/zh-tw/

Vize

https://vizecounselor.com/foreign-business-license-lawyer-thailand/medical-device-license/

HLF-TH-60

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：

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

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

Evershine RD：

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？

Evershine RD：

1. 第一級醫療器材

．國際標準組織醫療器材品質管理系統之認證（ISO 13485: 2003）

2. 第二、三級醫療器材：

．國際標準組織醫療器材品質管理系統之認證（ISO 13485）

．泰國「BLQS-DMSc」之測試與認證文件

3. 第四級醫療器材：

．國際標準組織醫療器材品質管理系統之認證（ISO 13485: 2003）

．泰國「BLQS-DMSc」之測試與認證文件

．醫療器材之臨床測試相關數據與實驗設計

．醫療器材製造流程說明文件

．若為進口之醫療器材，須額外繳交來源國之核准上市證明文件

1. Class 1 medical equipment

．International Organization for Standardization Medical Device Quality Management System Certification (ISO 13485: 2003)

2. Class II and III medical devices:

． International Organization for Standardization (ISO 13485) Certification of Medical Device Quality Management System

． Thailand “BLQS-DMSc” testing and certification documents

3. Class 4 medical devices:

． International Organization for Standardization Medical Device Quality Management System Certification (ISO 13485: 2003)

． Thailand “BLQS-DMSc” testing and certification documents

． Data and experimental design for clinical testing of medical devices

． Medical device manufacturing process description document

． If it is an imported medical device, an additional listing approval document from the country of origin must be submitted

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

HLF-TH-77

請問在泰國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：

Qualtech

https://www.qualtechs.com/zh-tw/

EECI

https://www.eeci.or.th/en/home/

HLF-TH-80

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：

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

HLF-TH-85

請問在泰國有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？

Evershine RD：

Ibcfirm

https://www.ibc-firm.com/

P&P

https://www.pnpinternationallegal.com/

Pacific Legal Group

http://www.pacificlegalgroup.com/

Contact Us

Bangkok Evershine BPO Service Limited Corp.
Email: bkk4ww@evershinecpa.com
Manager Paul , Speak in Thailandese English
WeChat: Paul0864580532

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4bkk@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
linkedin address:Dale Chen

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