Foreign airlines apply for branch offices in Taiwan Q&A
We help you set up a branch of foreign civil air transport enterprises. It applies to airlines passenger or cargo transport, regular or charter flights.
Send an email to tpe4ww.elr@evershinecpa.com
Director Jerry Chu, USA Graduate School Alumni, and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103
TW-CAA-010 What is the review process for foreign civil air transport enterprises to apply for operations in Taiwan?
Answer:
Review process diagram for foreign civil air transport enterprises to apply for operations in Taiwan https://www.caa.gov.tw/Article.aspx?a=508&lang=2 in English
It applies to airlines passenger or cargo transport, regular or charter flights.
It can appoint a Taiwan general agent, or it can set up a branch office in Taiwan by itself.
TW-CAA-020 What are the laws and regulations for foreign airlines to apply for branch offices in Taiwan?
TW-CAA-030 What are the forms and information requirements for foreign airlines to apply for branch offices in Taiwan?
Answer:
Information for foreign civil air transport enterprises to apply https://www.caa.gov.tw/ContentAndMorefiles.aspx?a=224&lang=2
in English
1.
Application by foreign civil air transport enterprise for appointing a general sales agent in Republic of China
2.
Application by foreign civil air transport enterprise for establishing a branch organization in Republic of China
If you are interested in our services,
please send an email to tpr2ww.elr@evershinecpa.com.
We will respond to you in 1-2 working days.
You may also call in working hours (Taipei and China Time):
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103
Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please contact us by email at HQ4TPE@evershinecpa.com
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外籍航空公司來台申請分公司 問答
我們協助外籍航空公司來台申請分公司，它適用於航空公司客運或貨運，適用於定期航線或包機。
發送電子郵件至tpe4ww.elr@evershinecpa.com 協理 Jerry Chu，美國北德大Denton，英語流利 手機：+886-939-357-735 電話：+886-2-2717-0515 分機 103
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.
We help you import your Aquatic Products into Taiwan including of Foreign-owned Company Registration services, TFDA Approval application ,apply to TFDA for border inspection when importing.
Send an email to tpe4ww.elr@evershinecpa.com Director Jerry Chu, USA Graduate School Alumni, and a well-English speaker Mobile: +886-939-357-735 Tel No.: +886-2-2717-0515 ext. 103
FDA-Food-010 A Foreign company would like to import Aquatic Products, what procedures this foreign company need to apply in Taiwan?
Answer: Three Major Procedures: 1: Company registration process 公司登記 2. Obtain the food and drug business login number (log in with the industrial and commercial certificate from TFDA: Food and Drug Administration of the Ministry of Health and Welfare) 取得食品藥物業者登入字號(衛生福利部食品藥物管理署…以工商憑證登入) https://www.fda.gov.tw/TC/index.aspx 3. Submit an application 14 days before importing the goods, entrust customs broker, apply to the Food and Drug Administration for border inspection. 貨品進口14天前提出申請，委託報關業者，向食藥署提出邊境查驗申請 https://www.fda.gov.tw/TC/sitecontent.aspx?sid=2525 The main documents are the Food and Related Products Import Inspection Application Form and the Food and Related Products Information Sheet.This is the TFDA’s suggested Standard Operating Procedure (SOP) for food industry operators, which outlines the document requirements for customs declaration and TFDA inspection. 主要文件是食品及相關產品輸入查驗申請書、食品及相關產品資料表 這是TFDA建議食品業者的SOP，列出海關報關、TFDA查驗的文件需求https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637423462806392129&type=2&cid=35480
FDA-Food-020 What are Foreign-own Company registration process? Answer: Step 1: Pre-check of company name and business scope Reference business items: F101050 Wholesale of aquatic products F101130 Wholesale of vegetables and fruits F102170 Wholesale of food and groceries F201030 Retail of aquatic products F401010 International trade G801010 Warehousing ZZ99999 Except for licensed businesses, businesses that are not prohibited or restricted by law may be operated Step 2: Company establishment registration Step 3: Profit-Seeking establishment registration
FDA-Food-030 How to confirm if foreign Aquatic Products can be imported into Taiwan? Answer: Firstly, you need to gain correct Taiwan HS Code for planning imported aquatic products. Please see below Q&A FDA-Food-040 on how to get HS Code
Secondly, check with colleagues of Taiwan Food and Drug Administration how to Import。
“Aquatic product control measures 水產品管制措施” based on above regulation: https://www.fda.gov.tw/TC/siteContent.aspx?sid=2405 | Published date: 2011-04-15 | Updated date: 2023-07-27 Published unit: District Management Center | 發布日期：2011-04-15 | 更新日期：2023-07-20 發布單位：區管理中心 1. Aquatic products (products under HS Code 03, 1604, 1605) have been subject to systematic inspection since January 1, 2018. Aquatic products from countries that have passed the systematic inspection can apply to the FDA for import inspection. The competent authorities of the exporting countries can go to the FDA’s digital management system for imported food (called IFDM, website ifdm.fda.gov.tw), fill in the questionnaire on the equivalence assessment of the aquatic product safety management system, and apply to the FDA for systematic inspection. 水產品(HS Code 03、1604、1605項下產品)自107年1月1日起實施系統性查核。 通過系統性查核國家之水產品，可向本署申請輸入查驗。輸出國主管機關可至本署輸入食品數位化管理系統(稱IFDM，網址ifdm.fda.gov.tw)，填寫水產品安全管理體系等效性評估問卷，向本署申請系統性查核 水產品安全管理體系等效性評估問卷
2. Countries that have passed the systematic inspection: New Zealand, Thailand, Australia, Canada, Lithuania, Indonesia. Aquatic products produced by approved production facilities in countries that have passed the systematic inspection can apply to the FDA for import inspection. Please fill in the approved factory number information of the batch of products in the “Manufacturer Code” column of the relevant form. The products can be imported only after passing the inspection. Approved production facilities can be queried at the link below. 已通過系統性查核國家: 紐西蘭、泰國、澳大利亞、加拿大、立陶宛、印尼。 通過系統性查核國家，其核准生產設施所生產之水產品，可向本署申請輸入查驗。請於相關表單之「製造廠代碼」欄位填具該批產品之核准工廠編號資訊，查驗合格後始得輸入。核准生產設施可至下方連結查詢。相關連結 紐西蘭水產品核准生產設施 泰國水產品核准生產設施 澳大利亞水產品核准生產設施 加拿大水產品核准生產設施 立陶宛水產品核准生產設施 印尼水產品核准生產設施
3. “List of aquatic products that can be imported from countries that have not passed the systematic inspection” can temporarily apply to the FDA for import food inspection. Relevant documents can be queried at the link below. Chinese mitten crabs, Philippine live lobster crayfish, and Vietnamese aquatic products must come from approved production facilities. Please fill in the approved factory number information of the batch of products in the “Manufacturer Code” column of the relevant form before applying to the FDA for import inspection. The products can be imported only after passing the inspection. Approved production facilities can be queried at the link below. 「未通過系統性查核國家得輸入之水產品號列」，暫可向本署申請輸入食品查驗。 相關檔案可至下方查詢。 未完成系統性查核程序國家得輸入之水產品號列-112年2月1日生效(出口日) 未完成系統性查核程序國家得輸入之水產品號列-112年8月15日新號列生效 中國大閘蟹、菲律賓活蟳龍蝦、越南水產品須來自核准生產設施，請於相關表單之「製造廠代碼」欄位填具該批產品之核准工廠編號資訊，始得向本署申請輸入查驗，查驗合格後始得輸入。核准生產設施可至下方連結查詢。 中國大閘蟹核准生產設施 菲律賓活蟳龍蝦核准生產設施 越南水產品核准生產設施 4. Shellfish products should be accompanied by an official health certificate containing the fishing or aquaculture site. Chinese mitten crabs should be accompanied by an official health certificate and a “dioxin and dioxin-like polychlorinated biphenyls” test report before applying to the FDA for import inspection. Relevant regulations can be queried at the link below.
貝類產品應檢附含捕撈養殖地之官方衛生證明文件，中國大閘蟹應檢附官方衛生證明文件及「戴奧辛及戴奧辛類多氯聯苯」檢驗報告，始得向本署申請輸入查驗。相關規定可至下方連結查詢。 5. Other border control measures can be queried at the file below. 其他邊境管制措施可至下方檔案查詢。 其他邊境管制措施
6. If there are other relevant regulations from other competent authorities such as BAPHIQ, they should also comply with those regulations before they can be imported. 如有其他主管機關如防檢局等之相關規定，亦應符合該些規定，始得輸入。
FDA-Food-040 How to get Taiwan HS code of Aquatic Products ?
Answer: Query the customs for the [product list](or tariff) of goods Customs phone: +886-2-2550-5500 ext. 1013 (aquatic products) HS code (HS Code) is an abbreviation of Harmonized System Code, which is the international customs-recognized standard for classifying import and export products. HS code in Taiwan is our CCC code (Standard Classification of Commodity of The Republic of China Code), which is generally referred to as the tariff number The first six digits of the CCC CODE are the HS code numbers, which can be queried at the following websites https://www.usacan.org.tw/index.php?pg=trading-tips&no=8&site-lang=tw: https://portal.sw.nat.gov.tw/APGQO/GC411 • http://db2.wtocenter.org.tw/tariff/Search_byHSCode.aspx In addition, you can also go to the Ministry of Finance Customs Administration’s product classification management system https://fbfh.trade.gov.tw/fh/ap/queryHSFormf.do , to query or query by chapter CCC CODE by 2-11 digit product name
Please be aware of below Warning: The above contents are digested by Evershine R&D and Education Center in 2023/08/03. Regulations might be changed as time goes forward and different scenarios will adopt different options. Before choosing options, please contact us or consult with your trusted professionals in this area. if you find the above contents need to be revised, please also let us know. We will have small compensation to you.
Contact Us
If you are interested in our services, please send an email to tpr2ww.elr@evershinecpa.com. We will respond to you in 1-2 working days.
You may also call in working hours (Taipei and China Time): Director Jerry Chu, USA Graduate School Alumni and a well-English speaker Mobile: +886-939-357-735 Tel No.: +886-2-2717-0515 ext. 103
Evershine Potential Serviceable City (2 months preparatory period): Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees. Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people. Besides, Evershine is Taiwan local Partner of ADP Streamline ®. (version: 2024/07) Please contact us by email at HQ4TPE@evershinecpa.com
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What are the classifications of medical devices in Taiwan? What is its official name? What is the intensity of management of different classifications? What is the governmental authority of medical devices? Website?
To determine whether a medical device is a listed medical device, you can first check the regulations on the classification and classification management of medical devices. If a product meets any of the classification items, it is listed as a medical device.
If it is an imported product, you can refer to the regulations of the importing country to determine whether the product is included in the medical device management of the original manufacturer, but for reference, it should still be based on the regulations of the Medical devices and Drug Administration of the Ministry of Health and Welfare.
Medical devices are classified as follows according to their degree of risk:
If a foreign company wants to sell medical devices in Taiwan, 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?
In the code table of the business of the Ministry of Economic Affairs, the last digit of the code is 0, which means no preliminary approval is required and 1 means that preliminary approval is required. Medical devices wholesale F108031；Medical devices retail F208031 To apply the business license, please follow the regulations of each county and city government.
If a foreign company wants to sell medical devices in Taiwan, can it assign a Taiwan company to act as a sales agent? What are the required documents and application procedures? If a foreign company sells medical devices for personal use, meaning that it does not need to be operated by a doctor or professional, to Taiwan, what are the required documents and application procedures? Do the packaging contents and various labels of medical devices require prior approval? In addition to Chinese, which other languages are allowed? Web page?
According to Article 8 of the “Enforcement Regulations of the Medical Device Management Act”, an application for medical devices inspection and registration must be filed in the name of a medical device manufacturer
The application is exclusively for personal use, which refers to medical devices that does not need to be operated by a doctor or professional. The number of applications shall meet the following requirements:
(1) Consumables exclusively for personal use, the quantity of which is limited to 6-month consumption.
(2) Instruments designed for personal use, limited to one (piece) of the same model. However, it is not limited to use in different locations or other special circumstances.
Applicants who apply for medical devices exclusively for personal use shall submit the following documents and materials:
Those applying for the project manufacture or import of medical devices for personal use that meet one of the following requirements can be imported through the convenient customs clearance management method announced by the central competent authority:
These regulations are formulated in accordance with Article 18 of the Medical Devices Act.
1. Communication transaction channel: refers to the channel through which consumers can buy and sell medical devices without actually viewing medical devices through radio, television, telephone, fax, catalogs, newspapers, magazines, the Internet, leaflets or other similar methods; communication Trading channel operators: refer to the operators that provide communication trading channels to medical device manufacturers (pharmacies) engaged in the sales of medical devices.
2. Those who want to sell medical devices through communication channels should meet one of the following qualifications:
(1) Approved registered medical device suppliers.
(2) Approved and registered pharmacies.
3. The medical devices sold in the front channel is limited to the first-class medical devices and the second-class medical devices listed in the appendix.
4. Medical device dealers (pharmacies) that sell medical devices through communication channels should also provide consumers with the following information on their channels:
(1) The name of the medical device, the license number or registration number, the name and address of the license owner or registration person, and the name and address of the manufacturer.
(2) The name, address, license number and consultation hotline of the medical device manufacturer (pharmacy).
(3) Add “Consumers should read the instruction manual of the medical device carefully before using it”.
(4) For products with measurement function, the items and base information of the service are regularly corrected.
Class II medical devices items that medical devices manufacturers and pharmacies can sell through communication channels
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)
What are the categories of cosmetics in Taiwan? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Cosmetics are categorized as general cosmetics and specific purpose cosmetics. Specific purpose cosmetics refers to the List of Specific Purpose Ingredients in Cosmetic Products regarding the use for sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening, or other purposes.
If categorized as specific purpose cosmetics, an application for approval license shall be submitted to TFDA for registration before import.
If categorized as general cosmetics, the ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan (R.O.C), ensuring safety and stability, and complete cosmetic notification and required labelling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises.
If a foreign company wants to sell cosmetics in Taiwan, 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：
在經濟部營業項目代碼表中的代碼尾數為0代表不需辦理特許證，1代表需要辦理特許證。
化粧品批發業F108040、化粧品零售業 F208040
In the code table of the business of the Ministry of Economic Affairs, the last digit of the code is 0, which means no preliminary approval is required, and 1 means that preliminary approval is required.
If a foreign company wants to sell cosmetics in Taiwan, can it assign a Taiwanese 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?
It is stated in Article 5 of the “Measures for the Issuance of Licenses for Special-purpose Cosmetics” that those who import the special-purpose cosmetics should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to application.
Do foreign companies need to apply for an approval before importing cosmetics sold to Taiwan? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetic packaging and labeling require prior approval? In addition to Chinese, which other languages are allowed? Website?
Specific purpose cosmetics, an application for approval license shall be submitted to TFDA for registration before import.
The ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan, ensuring safety and stability, and complete cosmetic notification and required labeling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises. The product labeling items need to include the manufacturer’s name, address, product name, license number, full ingredients, use, usage, weight or volume, batch number or date of manufacture, storage method and storage period, etc. Cosmetics imported from abroad need to list the name and address of the manufacturer.
For cosmetic products with outer packaging and containers, in addition to the Chinese name marked on the outer packaging, the container should at least display the name in Chinese or other languages. All ingredient names are marked in Chinese or English.
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 cosmetic packaging and labeling require prior approval? In addition to Chinese, which other languages are allowed? Website?
It is stated in Article 5 of the “Measures for the Issuance of Licenses for Special-purpose Cosmetics” that those who import the special-purpose cosmetics should submit a copy of the company registration or business registration certificate, which means that only the agent who can provide the local (Taiwan) company registration or business registration document has the right to application.
The ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan, ensuring safety and stability, and complete cosmetic notification and required labeling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises. The product labeling items need to include the manufacturer’s name, address, product name, license number, full ingredients, use, usage, weight or volume, batch number or date of manufacture, storage method and storage period, etc. Cosmetics imported from abroad need to list the name and address of the manufacturer.
For cosmetic products with outer packaging and containers, in addition to the Chinese name marked on the outer packaging, the container should at least display the name in Chinese or other languages. All ingredient names are marked in Chinese or English.
According to Paragraph 1, Article 5 of Regulations for Issuance of License of Specific Purpose Cosmetics, an applicant applies for the registration of the license for importing specific purpose cosmetics shall submit an application with following documents, information, and pay the fee to the TFDA:
A copy of company registration or business registration certificate.
Drafts of product labels, leaflets, and packaging.
The authorization letter issued within the past two years.
The MFSC issued within the past two years.
An ingredient list issued within the past two years.
The certificate of analysis.
For the contract manufacturer, a certificate identifies the relationship between the hiring firm and the contract manufacturer.
After a foreign subsidiary imports cosmetics and entrusts a distributor in Taiwan to sell it, does the distributor need a cosmetics 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?
For specific purposes of cosmetics, an application for approval license shall be submitted to TFDA for registration before import.
In case of consumer damage caused by product defects, Taiwanese importers (distributors/agents) are responsible for making compensation for consumer damages. The relevant regulations can be clearly specified in the contracts between Taiwanese importers and foreign original companies; moreover, product liability insurance can also be purchased for products.
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)
What are the categories of health food in Taiwan? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
According to Health Food Control Act Article 2, the term “health food” shall denote food with health care effects, having been labeled or advertised with such effects.
The term “health care effects” shall mean an effect that has been scientifically proven to be capable of improving people’s health, and decreasing the harms and risks of diseases. However, it is not a medical treatment aimed at treating or remedying human diseases; such “health care effects” shall be announced by the central competent authority.
The classification of health food safety assessment is basically based on the classification stated in health food safety assessment methods. In short, the category 1 and category 2 are conventional raw materials, and the category 3 and category 4 are unconventional raw materials. Regarding the division between the category 1 and the category 2, generally, the conventional raw materials that are not extracted and concentrated by conventional methods should be put in category 2. The edible Chinese medicine materials that are not classified as “the medicine materials that can be used for food” are sorted into category 2.
外國公司要到台灣銷售健康食品，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 health food in Taiwan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain 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?
In the code table of the business of the Ministry of Economic Affairs, the last digit of the code is 0, which means no preliminary approval is required and 1 means that preliminary approval is required. Food wholesale F102170；Food retail F203010
外國公司要到台灣銷售健康食品，可以指派台灣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 health food in Taiwan, can it assign a Taiwanese 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：
健康食品申請商須提出公司登記或商業登記，故個人無法申請健康食品查驗登記。
Those who import the health food should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to application.
A health food permit shall be issued only if one of the following requirements is met under the purpose of this Act.
1. Duly supported by scientific assessment of the safety and health care effects of food that they are harmless and carry definite, certain health care effects; if current technology cannot identify ingredients contributing to such effects, the ingredients with the relevant health care effects and supporting literature shall be enumerated and provided to the central competent authority for evaluation and verification.
2. Ingredients conforming to the Health Food Specification Standards set by the central competent authority (fish oil and red yeast rice).
The methods by which health care effects and safety are assessed, and by which standards are determined in the preceding paragraph shall be determined by the central competent authority. If the central competent authority has not yet determined a method to assess the health care effects, a 2 method submitted by academics shall be reviewed and approved by the central competent authority.
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants. (2022/02/10)
Do foreign companies need to apply for approval before importing health food sold to Taiwan? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? In addition to Chinese, which other languages are allowed? Website?
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
The health food application inspection and registration is a two-stage review system: 80,000 NTD for the initial review, 170,000 NTD for the re-examination, and an additional certificate fee of 1,500 NTD. The number of days for the initial review is 60 days, and the days for the review are 180 days, excluding the time for the supplier to make up the documents.
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
The following material facts shall be conspicuously displayed on the containers, packaging or written instruction of health food in Chinese and in commonly used symbols:
1. product name;
2. name of the ingredients; those that contain two or more ingredients shall
indicate the respective ingredients in descending order of proportion;
3. net weight, volume or quantity;
4. name of food additives; in the case of a mixture of two or more food
additives which are named according to its function shall indicate the name of each additive separately;
5. expiry date, method and conditions of preservation;
6. name and address of the responsible business operator; the name and address of the importer shall be specified if the health food is imported;
7. the approved health care effects;
8. reference number of the permit, the legend of “health food” and standard logo;
9. amount of intake and important message for consumption of the health food, possible side effect and other necessary warnings;
10. nutrient and its content; and
11. other material facts designated by the central competent authority.
The format and contents of the labeling described in subparagraph 10 above
shall be prescribed by the central competent authority.
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 health food packaging and labeling require prior approval? In addition to Chinese, which other languages are allowed? Website?
Those who import the health food should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to apply.
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
The health food application inspection and registration is a two-stage review system: 80,000 NTD for the initial review, 170,000 NTD for the re-examination, and an additional certificate fee of 1,500 NTD. The number of days for the initial review is 60 days, and the days for the review are 180 days, excluding the time for the supplier to make up the documents.
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
The following material facts shall be conspicuously displayed on the containers, packaging or written instruction of health food in Chinese and in commonly used symbols:
1. product name;
2. name of the ingredients; those that contain two or more ingredients shall
indicate the respective ingredients in descending order of proportion;
3. net weight, volume or quantity;
4. name of food additives; in the case of a mixture of two or more food
additives which are named according to its function shall indicate the name of each additive separately;
5. expiry date, method and conditions of preservation;
6. name and address of the responsible business operator; the name and address of the importer shall be specified if the health food is imported;
7. the approved health care effects;
8. reference number of the permit, the legend of “health food” and standard logo;
9. amount of intake and important message for consumption of the health food, possible side effect and other necessary warnings;
10. nutrient and its content; and
11. other material facts designated by the central competent authority.
The format and contents of the labeling described in subparagraph 10 above
shall be prescribed by the central competent authority.
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
The health care effect assessment report shall be derived from the actual trial of the products. The safety assessment report shall be derived from the final products under the following principles.
(1) The no-observed-adverse-effect level (NOAEL) shown on the safety assessment report can be used to calculate the safety of recommended intake.
a. Products of safety category 3 or above shall have no adverse effect at a dose greater than or equal to 100 times of the recommended human intake.
b. In principle, the products of safety category 2 in the solid forms of capsule, tablet, powder, or liquid products with a recommended daily intake of 100 mL (or less), their no-observed-adverse-effect level shall be greater than 60 times no adverse effect dose should be greater than or equal to the recommended intake of 60 times of the recommended human intake. If the daily recommended intake of the product is higher than the aforesaid, the no-observed-adverse effect level shall be greater than or equal to 30 times of the recommended intake. c. The health food review committee of the central competent health authority may comprehensively evaluate the animal feeding limit and the formula (such as consumption limit and quantity of each ingredients), process (such as manufacture methods of raw materials and products, whether the concentration and purification of specific ingredients are involved), characteristics and consumption method of the product. If necessary, no-observed-adverse effect level may be required to be greater than or equal to 100 times of the recommended intake.
(2) The safety assessment report shall be derived from the final products. If the feeding limit (including concentration) exceeds the prescribed limit but still fails to meet the requirements mentioned in the preceding paragraph, additional testing may be required on raw materials or ingredients of the product.
(3) If the product used in the safety assessment is not the final product, there shall be sufficient evidence to prove the relevance of the tested product and final products. Description regarding necessity and rationality shall be attached.
If the assessment method used in the test report is slightly different from the method announced by the FDA (such as the measurement method), the scientific basis of the method shall be attached for the assessment. If the assessment method used in the test report is not designated by the FDA (such as health care effect items or assessment mode), the applicant can first follow “Guide on proposal of health care effect assessment methods of health food” and provide related information. After passing the evaluation, the applicant may be notified to accept the examination of the investigation and registration cases.
Health care effect assessment report that is published in academic journals are preferred. If the assessment report has not been published, it shall be completed by institutions with public credibility, or by the company itself if the research ability and impartiality of the company can be supported.
After a foreign subsidiary imports health food and entrusts a distributor in Taiwan to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if health food products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
In case of consumer damage caused by product defects, Taiwanese importers (distributors/agents) are responsible for making compensation for consumer damages. The relevant regulations can be clearly specified in the contracts between Taiwanese importers and foreign original companies; moreover, product liability insurance can also be purchased for products.
The Ministry of Health and Welfare announced on September 28, 110 to amend the “food industry insured product liability insurance”. From January 1, 111, product liability insurance should be insured for imported or manufactured food and food additives
