馬來西亞化妝品登記法規問題集

馬來西亞化妝品登記法規問題集

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各國化妝品登記法規問答集

HLF-TW-10
請問馬來西亞對於化妝品的歸類方式為何?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 cosmetics in Malaysia? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD:

化妝品的定義是指接觸於人體各外部器官(表皮(皮膚)、毛髮、指(趾)甲、嘴唇和外生殖器)或口腔內的牙齒和口腔黏膜,以清潔、發出香味、改善外觀、改善身體氣味或保護身體使之保持良好狀態為主要目的的物質和製劑。

化妝品類別:

1. 用於皮膚(手、臉、腳等)的面霜、乳液、乳液、凝膠和油

2. 面膜(化學脫皮產品除外)

3. 著色基料(液體、糊劑、粉末)

4. 化妝粉、浴後粉、衛生粉等

5. 香皂、除臭皂等。

6. 香水、花露水和古龍水

7. 沐浴和淋浴用品(鹽、泡沫、油、凝膠等)

8. 脫毛劑

9. 除臭劑和止汗劑

10.護髮產品

.染髮劑和漂白劑

.用於波浪、拉直和固定的產品

.設置產品

.清潔產品(乳液、粉末、洗髮水)

.調理產品(乳液、面霜、油)

.美髮產品(乳液、亮油、亮油)

11.剃須產品(面霜、泡沫、乳液等)

12.面部和眼部彩妝和卸妝產品

13.適用於嘴唇的產品

14.牙齒和口腔護理產品

15.指甲護理和化妝產品

16.用於外部私密衛生的產品

17.日光浴產品

18.防曬太陽的產品

19.美白產品

20.抗皺/抗衰老產品

不得歸類為化妝品:

1. 用於治療疾病/感染的產品

2. 性功能產品:男性和女性(用於生殖器部位的留存產品)

3. 口服產品

4. 注射劑:維生素C、膠原蛋白、透明質酸

5. 產品注入鼻子、眼睛和耳朵

6. 產品用途超出化妝品範圍(例如用於關節疼痛、扭傷的按摩油和用於影響精神、生理功能的精油)

7. 瘦身產品

8. 用滴管瓶/容器或噴霧形式包裝的眼部製劑

在馬來西亞,藥物管制局 (DCA)是負責監管化妝品的機構。
國家藥品監督管理局 (NPRA) 是 DCA 的秘書處,負責化妝品通知流程和上市後監督。

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”
Cosmetic classification:

1. Creams, lotions, lotions, gels and oils for the skin (hands, face, feet, etc.)

2. Masks (except chemical peeling products)

3. Coloring base (liquid, paste, powder)

4. Cosmetic powder, after-bath powder, hygiene powder, etc.

5. Soap, deodorant soap, etc.

6. Perfume, toilet water and cologne

7. Bath and shower supplies (salt, foam, oil, gel, etc.)

8. Depilatories

9. Deodorants and antiperspirants

10. Hair care products

. Hair Dye and Bleach

. Products for Waving, Straightening and Fixing

. Set up products

. Cleaning Products (Lotions, Powders, Shampoos)

. Conditioning products (lotions, creams, oils)

. Hair products (lotions, polishes, polishes)

11. Shaving products (cream, foam, lotion, etc.)

12. Face and Eye Makeup and Makeup Removers

13. Products for lips

14. Teeth and oral care products

15. Nail Care & Makeup Products

16. Products for external intimate hygiene

17. Sunbath products

18. Sun protection products

19. Skin Whitening Products

20. Anti-Wrinkle/Anti-Ageing Products

Not classified as cosmetic:

1. Products for the treatment of disease/infection

2. Sexual function products: male and female (preserved products for genital area)

3. Oral products

4. Injections: Vitamin C, Collagen, Hyaluronic Acid

5. The product is injected into the nose, eyes and ears

6. The use of the product is beyond the scope of cosmetics (such as massage oil for joint pain, sprain and essential oil for affecting mental and physiological functions)

7. Slimming products

8. Ophthalmic preparations in dropper bottles/containers or in spray form

In Malaysia, the Drug Control Authority (DCA) is the agency responsible for regulating cosmetics.
The National Drug Administration (NPRA) is the secretariat of the DCA and is responsible for the cosmetic notification process and post-market surveillance.

【參考連結】

https://www.npra.gov.my/index.php/en/

HLF-TW-20
外國公司要到馬來西亞銷售化妝品,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 cosmetics in Malaysia, 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:

須在馬來西亞當地註冊化妝品公司。批發商必須先申請健康/化妝品批發商許可證才能註冊其產品,許可證有效期為1年。
在馬來西亞註冊所有企業(包括外國公司),馬來西亞公司委員會(SSM)的企業註冊處管理。所有公司必須在成立後 30 天內任命一名公司秘書(需要在馬來西亞擁有主要居住地)。
秘書必須獲得馬來西亞公司委員會( SSM )的許可,或者是國內貿易和消費者事務部規定的專業組織的成員。

商業註冊需要以下資料:

1.公司名稱

2.私人或上市公司

3.建議的業務類型(必須要是健康/化妝品類)

4.註冊辦事處地址

5.營業地址

6.繳足資本(最低 RM1)

7.董事和發起人的詳細信息

8.董事和發起人的聲明

9.負責註冊成立的個人的合規聲明

10.附加文件(如有)

A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

【參考連結】

https://www.ssm.com.my/Pages/Home.aspx

HLF-TW-25
假如需要辦理,請問馬來西亞有專業服務公司可以協助辦理化妝品公司營業許可證?

HLF-TW-30
外國公司要到馬來西亞銷售化妝品,可以指派馬來西亞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 cosmetics in Malaysia, can it assign a Malaysian company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD:

可以,批發商必須申請健康/化妝品批發商許可證才能註冊並銷售其產品,許可證有效期為1年。
在馬來西亞註冊所有企業(包括外國公司),馬來西亞公司委員會(SSM)的企業註冊處管理。
所有公司必須在成立後 30 天內任命一名公司秘書(需要在馬來西亞擁有主要居住地)。
秘書必須獲得馬來西亞公司委員會( SSM )的許可,或者是國內貿易和消費者事務部規定的專業組織的成員。

商業註冊需要以下資料:

1.公司名稱

2.私人或上市公司

3.建議的業務類型(必須要是健康/化妝品類)

4.註冊辦事處地址

5.營業地址

6.繳足資本(最低 RM1)

7.董事和發起人的詳細信息

8.董事和發起人的聲明

9.負責註冊成立的個人的合規聲明

10.附加文件(如有)

CNH應向發生國家藥品監督管理局 (NPRA)報告不良事件,無論報告的來源(消費者、醫療保健專業人員等)如何。
所有嚴重的不良事件應該報告。不要求報告非嚴重不良事件。
只要有理由懷疑化妝品可能是引起反應的原因,就必須報告所有嚴重的不良事件。

Yes. A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【參考連結】

https://www.ssm.com.my/Pages/Home.aspx

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-35

HLF-TW-40
外國公司銷售到馬來西亞化妝品本身,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?
化妝品包裝內容及各種標示,需要事先核准嗎?可允許的語文除了馬來文外,其他哪種語文也可以?網頁?

Do foreign companies need to apply for an approval before importing cosmetics sold to Malaysia?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD:

須以馬來西亞當地健康/化妝品公司通知持有人 (CNH)的名義申請。所有化妝品的製造、銷售、供應、進口或分銷都必須先通知國家藥品監督管理局 (NPRA),然後才能在馬來西亞銷售。
希望將化妝品帶入馬來西亞的外國公司,首先必須指定當地代理人作為化妝品通知持有人 (CNH)。
化妝品通知持有人負責將化妝品投放市場。

化妝品通知持有人 (CNH) 必須是化妝品領域的本地註冊公司,具有永久地址並在馬來西亞公司委員會註冊(其業務範圍顯示的健康/化妝品相關的公司)。
所有通知的提交都透過 NPRA 網站中的Quest 系統進行線上申請,必須註冊會員、填寫每種化妝品的通知表,以及完成付款。
CNH在收到授權後始得製造或進口化妝品。

所需文件:

1. 產品詳情

.產品名稱、產品類型、預期用途和產品介紹

.製造商和組裝商的名稱和地址(如有)

2. CNH 的名稱、地址、聯繫電話、電子郵件

3. 進口商名稱、地址(如有)

4. 完整的產品成分表

.必須聲明限制成分的含量,即百分比(%)

.授權書/聲明書/合同製造書(如適用)

5. 產品標籤

注意事項:提交給 NPRA 的任何文件和材料必須使用馬來文或英語。其他語言的翻譯版本必須得到認可或授權。

馬來西亞化妝品標籤要求:化妝品外包裝應標註以下內容(沒有外包裝的情況下,要在化妝品的直接包裝上標註)

1.化妝品的名稱及其功能,除非從產品的介紹中可以清楚地看出

2.化妝品的使用說明,除非從產品名稱或外觀中明確

3.完整的成分列表。成分必須在添加時按重量降序聲明。

.香水和芳香組合物及其原料可簡稱為香水、香味、香氣或風味。
濃度小於 1% 的成分可以在濃度大於 1% 的成分之後以任意順序列出。
根據規範中採用的名稱,著色劑可在其他成分之後以任意順序列出。

.對於以多種色調銷售的裝飾性化妝品,可以列出該範圍內使用的所有著色劑,前提是需要添加術語“可能包含”或“+/-”。成分應使用最新版本的標準參考中的命名法來指定。植物藥和植物提取物應按其屬和種進行鑑別。
但是,以下不應被視為成分:

.所用原材料中的雜質

.準備中使用但不使用的輔助技術材料

.材料作用溶劑,或香水和芳香組合物的載體

4. 製造國;

5. CNH 的名稱和地址

6. 以公制和英制的重量或體積內容

7. 生產批號

8. 產品的製造日期或有效期,以明確的方式(例如月/年)。

.日期應明確表示,並應由月和年或按日、月、年的順序組成。
最低保質期應是該產品在適當條件下儲存的日期,直至其繼續發揮其初始功能,特別是保持符合安全要求的日期。
前面應加上到期日字樣。如有必要,該信息應補充說明為保證規定的耐用性必須滿足的條件。
對於最短保質期少於 30 個月的化妝品,必須註明有效期。

9. 使用中應遵守的特殊注意事項,尤其是使用條件和警告,必須出現在標籤上以及化妝品的任何特殊預防信息。

 10. 所有標示內容應易於閱讀、清楚、可以理解、不可磨滅。

 11. 標籤上的信息應為馬來文和(或)英文。

動物源性成分聲明:

1.產品標籤上必須有聲明(任何格式)表明存在動物源性成分

2.對於牛或豬來源的成分,必須確切的申報動物

3. CNH 的有效聯繫電話。

如果容器或包裝的尺寸、形狀或性質不符合允許展示規定的詳情,可以使用傳單、小冊子、吊牌、展示板、收縮包裝等替代,至少需要標註以下內容:

1. 化妝品名稱

2. 生產批號

3. 如果化妝品以散裝容器形式進口,以下細節至少應出現在容器上:

.化妝品名稱

.製造商名稱和製造批號

4. 所有標示內容應易於閱讀、清楚、可以理解、不可磨滅。

清真標誌:產品已獲得馬來西亞伊斯蘭發展部(Jabatan Kemajuan Islam Malaysia,JAKIM)該或任何授權的伊斯蘭機構的清真認證和批准,可以自願標識於核可的化妝品上。

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).
The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed.
CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

. Product name, product type, intended use and product description

. Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

. The content of restricted ingredients must be declared, i.e. percentage (%)

. Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English.
Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

. Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

. For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference.
Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

. Impurities in the raw materials used

. Assistive Technology Materials Used in Preparation but Not Used

. The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

. Dates should be clearly indicated and should consist of months and years or in the order day, month, and year.
The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date.
If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

. Cosmetic name

. Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-45

HLF-TW-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?化妝品包裝內容及各種標示,需要事先核准嗎?
可允許的語文除了馬來文外,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 cosmetics packaging and labeling require prior approval?
In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD:

須以馬來西亞當地健康/化妝品公司通知持有人 (CNH)的名義申請。
所有化妝品的製造、銷售、供應、進口或分銷都必須先通知國家藥品監督管理局 (NPRA),然後才能在馬來西亞銷售。
希望將化妝品帶入馬來西亞的外國公司首先必須指定當地代理人作為化妝品通知持有人 (CNH)。
化妝品通知持有人負責將化妝品投放市場。

化妝品通知持有人 (CNH) 必須是化妝品領域的本地註冊公司,具有永久地址並在馬來西亞公司委員會註冊(其業務範圍顯示的健康/化妝品相關的公司)。
所有通知的提交都透過 NPRA 網站中的Quest 系統進行線上申請,必須註冊會員、填寫每種化妝品的通知表,以及完成付款。
CNH在收到授權後始得製造或進口化妝品。

所需文件:

1. 產品詳情

.產品名稱、產品類型、預期用途和產品介紹

.製造商和組裝商的名稱和地址(如果有)

2. CNH 的名稱、地址、聯繫電話、電子郵件

3. 進口商名稱、地址(如有)

4. 完整的產品成分表

.必須聲明限制成分的含量,即百分比(%)

.授權書/聲明書/合同製造書(如適用)

5. 產品標籤

注意事項:提交給 NPRA 的任何文件和材料必須使用馬來文或英語。其他語言的翻譯版本必須得到認可或授權。
馬來西亞化妝品標籤要求:化妝品外包裝應標註以下內容(沒有外包裝的情況下,要在化妝品的直接包裝上標註)

1.化妝品的名稱及其功能,除非從產品的介紹中可以清楚地看出

2.化妝品的使用說明,除非從產品名稱或外觀中明確

3.完整的成分列表。成分必須在添加時按重量降序聲明。

.香水和芳香組合物及其原料可簡稱為香水、香味、香氣或風味。
濃度小於 1% 的成分可以在濃度大於 1% 的成分之後以任意順序列出。根據規範中採用的名稱,著色劑可在其他成分之後以任意順序列出。

.對於以多種色調銷售的裝飾性化妝品,可以列出該範圍內使用的所有著色劑,前提是需要添加術語“可能包含”或“+/-”。
成分應使用最新版本的標準參考中的命名法來指定。植物藥和植物提取物應按其屬和種進行鑑別。
但是,以下不應被視為成分:

.所用原材料中的雜質

.準備中使用但不使用的輔助技術材料

.材料作用溶劑,或香水和芳香組合物的載體

4. 製造國;

5. CNH 的名稱和地址

6. 以公制和英制的重量或體積內容

7. 生產批號

8. 產品的製造日期或有效期,以明確的方式(例如月/年)。

.日期應明確表示,並應由月和年或按日、月、年的順序組成。
最低保質期應是該產品在適當條件下儲存的日期,直至其繼續發揮其初始功能,特別是保持符合安全要求的日期。
前面應加上到期日字樣。如有必要,該信息應補充說明為保證規定的耐用性必須滿足的條件。
對於最短保質期少於 30 個月的化妝品,必須註明有效期。

9. 使用中應遵守的特殊注意事項,尤其是使用條件和警告,必須出現在標籤上以及化妝品的任何特殊預防信息。10. 所有標示內容應易於閱讀、清楚、可以理解、不可磨滅。

11. 標籤上的信息應為馬來文和(或)英文。

動物源性成分聲明:

1.產品標籤上必須有聲明(任何格式)表明存在動物源性成分

2.對於牛或豬來源的成分,必須確切的申報動物

3. CNH 的有效聯繫電話。

如果容器或包裝的尺寸、形狀或性質不符合允許展示規定的詳情,可以使用傳單、小冊子、吊牌、展示板、收縮包裝等替代,至少需要標註以下內容:

1. 化妝品名稱

2. 生產批號

3. 如果化妝品以散裝容器形式進口,以下細節至少應出現在容器上:

.化妝品名稱

.製造商名稱和製造批號

4. 所有標示內容應易於閱讀、清楚、可以理解、不可磨滅。

清真標誌:產品已獲得馬來西亞伊斯蘭發展部(Jabatan Kemajuan Islam Malaysia,JAKIM)該或任何授權的伊斯蘭機構的清真認證和批准,可以自願標識於核可的化妝品上。

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed. CNH may not manufacture or import cosmetic products until authorized.needed file:

1. Product Details

. Product name, product type, intended use and product description

. Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

. The content of restricted ingredients must be declared, i.e. percentage (%)

. Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

. Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

. For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference. Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

. Impurities in the raw materials used

. Assistive Technology Materials Used in Preparation but Not Used

. The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

. Dates should be clearly indicated and should consist of months and years or in the order day, month, and year. The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

. Cosmetic name

. Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-55

HLF-TW-60
經過核准登記的化妝品,進口到馬來西亞要檢附什麼文件?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 cosmetics into Malaysia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD:

須以馬來西亞當地健康/化妝品公司擔任化妝品通知持有人 (CNH)的名義申請進口。
所有化妝品的製造、銷售、供應、進口或分銷都必須先通知 NPRA,然後才能在馬來西亞銷售。
希望將化妝品帶入馬來西亞的外國公司首先必須指定當地代理人作為化妝品通知持有人 (CNH)。


化妝品通知持有人負責將化妝品投放市場。

化妝品通知持有人 (CNH) 必須是化妝品領域的本地註冊公司,具有永久地址並在馬來西亞公司委員會註冊(其業務範圍顯示的健康/化妝品相關的公司)。
所有通知的提交都透過 NPRA 網站中的Quest 系統進行線上申請,必須註冊會員、填寫每種化妝品的通知表,以及完成付款。
CNH在收到授權後始得製造或進口化妝品。

所需文件:

1. 產品詳情

.產品名稱、產品類型、預期用途和產品介紹

.製造商和組裝商的名稱和地址(如果有)

2. CNH 的名稱、地址、聯繫電話、電子郵件

3. 進口商名稱、地址(如有)

4. 完整的產品成分表

.必須聲明限制成分的含量,即百分比(%)

.授權書/聲明書/合同製造書(如適用)

5. 產品標籤

注意事項:提交給 NPRA 的任何文件和材料必須使用馬來文或英語。其他語言的翻譯版本必須得到認可或授權。
要將貨物進口到馬來西亞,需要向馬來西亞皇家海關署(JKDM)申報、繳納關稅/稅款的進口稅、消費稅、銷售稅。

1.海關申報:所有進口到馬來西亞的貨物必須通過以下方式擇一申報

.指定報關員

.自我聲明(AEO 計劃 – AEO 門戶)

.直接用戶

2. 商品分類:進口商需要獲得對要進口到馬來西亞的商品,的確認通過獲取貨物的正確關稅代碼是否需要繳納任何關稅/稅款。

3. 檢查物品是否為受控商品或進口違禁品:

.檢查擬進口的貨物是否為管制貨物或受當局禁止或限制進口的貨物。

.確認進口之前獲得許可/批准。

4. 申報和準備海關放行文件:每個進口商應在貨物抵達或抵達馬來西亞時,親自或由其代理人對進口貨物進行完整和真實的申報。

.電子報關單

.提交進口許可證(電子檔案或副本)

.提單/空運單

.發票(採購訂單或信用證)

.裝箱單

.原產國證明

.其他相關文件(檢驗證書、分析證書、成分證書、清真證書、產品規格證書等)

5. 貨物檢驗:JKDM保留檢查貨物以確保進口符合法律法規的權利。

6. 繳納關稅/稅款進口:貨物的應付關稅/稅款必須由進口商在貨物到達時支付。可以通過櫃檯或電子支付。

7. 海關批准

8. 海關放行

9. 保存文檔:進口記錄在馬來西亞保存七年

A local health/cosmetic company in Malaysia is required to apply for import in the name of the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia. A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope). All notification submissions are made online through the Quest system on the NPRA website. Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed. CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

. Product name, product type, intended use and product description

. Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

. The content of restricted ingredients must be declared, i.e. percentage (%)

. Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

To import goods into Malaysia, import duty, excise duty, sales tax is required to be declared to the Royal Malaysian Customs Department (JKDM) and paid for duties/taxes.

1. Customs declaration: All goods imported into Malaysia must be declared through one of the following methods

.Designated Customs Broker

.Self Declaration (AEO Programme – AEO Portal)

.Direct users

2. Commodity classification: The importer needs to obtain confirmation of the goods to be imported into Malaysia by obtaining the correct tariff code of the goods if any duties/taxes are to be paid.

3. Check if the item is a controlled commodity or an imported contraband:

.Check whether the goods to be imported are regulated goods or goods whose importation is prohibited or restricted by the authorities.

.Confirm permission/approval prior to import.

4. Declaration and preparation of customs release documents: Each importer shall make a complete and true declaration of the imported goods in person or by his agent upon arrival or arrival in Malaysia.

. Electronic customs declaration

. Submit import license (electronic file or copy)

.Bill of Lading / Air Waybill

.Invoice (Purchase Order or Letter of Credit)

.Packing List

.Certificate of country of origin

.Other relevant documents (inspection certificate, analysis certificate, composition certificate, halal certificate, product specification certificate, etc.)

5. Goods inspection: JKDM reserves the right to inspect the goods to ensure that the imports comply with laws and regulations.

6. Pay Duties/Taxes Import: Duties/taxes payable on the goods must be paid by the importer upon arrival of the goods. Payment can be made over the counter or electronically.

7. Customs Approval

8. Customs release

9. Preservation of documents: Import records are kept in Malaysia for seven years

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

http://www.customs.gov.my/en/pages/main.aspx

HLF-TW-70
馬來西亞化妝品審核機構,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:

須附上良好生產規範 (GMP):

1. 所有化妝品必須照化妝品良好生產規範指南或同等標準進行生產

2. 當地製造商需要接受 NPRA 的 GMP 審核員的定期檢查;對於外國製造商,應根據 NPRA 的要求提供證明 GMP 合規性的文件。

3. 與GMP等效標準:

(1) 世界衛生組織 (WHO)的藥品良好生產規範

(2) 澳大利亞治療用品管理局 (TGA) 的治療用品防曬產品良好生產規範

(3) ISO 22716:化妝品 – 良好生產規範 (GMP) – 良好生產規範指南

4.良好生產規範 (GMP)所需文件

(1)原包裝材料規格

.材料名稱

.材料說明

.測試參數和接受限度

.技術圖紙(如果適用)

.特殊預防措施,例如儲存和安全條件(如有必要)

(2)散裝和成品規格

.產品名稱

.說明

.物理性質

.化學分析和/或微生物分析及其接受限度(如有必要)

.儲存條件和安全預防措施(如有必要)

(3) 生產文件

(4) 主配方

.產品名稱和產品代碼/編號

.預期的包裝材料和儲存條件

.使用的原材料清單

.使用的設備清單

.過程控制及其在加工和包裝方面的限制(如果適用)

(5) 批量生產記錄(BMR):每批產品都必須準備批次生產記錄。

.批量公式

.製造工藝簡述

.批號或代碼

.加工和包裝的開始和結束日期

.主要設備線路或位置的標識

.加工的設備的清潔記錄

.過程控制和實驗室結果,例如 pH 值和溫度測試記錄

.包裝線檢驗記錄

.各個步驟期間執行的任何採樣

.特定故障或差異的任何調查

.包裝和標籤產品的檢查結果

(6)質量控制記錄:起始原料、中間體、散裝產品和成品每次測試、化驗結果放行或拒絕的記錄都須要維護。

.材料識別

.供應商名稱

.收貨日期

.原始批號(如果具備)

. 批號

.質控編號

.收貨數量

. 取樣日期

.質量控制結果

產品信息文件(PIF):

1. CNH 應負責提供 NPRA 要求的所有產品信息、證書、文件和數據。 PIF 可以是檔案形式(即存儲在特定位置的大量紙質記錄)或電子格式。

2.文件內容包含

(1) 行政文件和產品概要

.產品的身份、製造商、組裝商、進口商和 CNH 的名稱和地址

.產品所有者的授權書或聲明書和合同製造書(如果適用)

.其他相關行政文件,例如:營業執照、公司註冊證書

.香精,成分的名稱和代碼以及供應商的身份

.外標籤和內標籤

.消費者信息傳單和使用說明

.認可機構簽發/背書的文件(表明是根據化妝品 GMP 指南或任何等效指南製造的)

.產品的批次編碼系統/密鑰

.安全聲明(簽署的意見聲明,包括安全評估員的姓名和資格)

.已確認對人類健康的不良影響(摘要)

.產品功效評估的總結報告

 (2) 原材料質量數據

.每種成分的規格

.每種成分的規格相對應的分析方法

.香料供應商的名稱和地址及符合標準的聲明

.香精材料,請指定產品的名稱和代號

.供應商區提供原材料安全數據:已發布的數據或來自東盟化妝品科學機構 (ACSB)、歐盟消費品科學委員會 (SCCP) 或美國化妝品等科學委員會的報告 成分審查委員會 (CIR)。

(3) 成品質量數據

.產品的定性定量配方(INCI或其他經批准的參考名稱和相應的成分濃度),配方應說明每種原材料/成分的功能

.製造商、組裝商和包裝商的名稱、國家和地址

.製造過程總結

.根據 NPRA 的要求提供有關製造過程、質量控制和相關製造文件的更多詳細信息

.化妝品微生物控制和化妝品成分化學純度的標準

.對應於檢查規範的分析方法

.支持有效期的穩定性測試數據/報告或穩定性評估

 (4) 安全性和有效性數據

.根據其成分、化學結構和暴露水平簽署的成品對人體健康的安全性評估報告

.安全評估員的簡歷

.已確認或記錄的因使用該化妝品而對人體健康造成的不良事件或不良影響的最新彙編報告

 3. 注意事項:CNH 應使 PIF置於標籤上指定的地址,便於監管機構取用,建議在產品最後一次投放市場後至少保留 3 年。

良好分銷規範 (GDP)

1. 進口商和批發商必須遵守良好分銷規範 (GDP) 的原則。

2. 書面說明應描述可能影響材料和/或產品和/或化妝品或分銷活動質量的不同操作:

.收貨和檢查交貨

.場所的儲存、清潔和維護(包括害蟲控制)

.儲存條件的記錄

.現場庫存和運輸途中貨物的安全

.從可售庫存中提取記錄

.客戶訂單記錄

.退回的材料和/或產品和/或化妝品、召回計劃等

3. 這些程序應由授權人員批准、簽署並註明日期。

4. 應在進行每項操作時進行記錄,並以可追溯所有重要活動或事件的方式進行。

5. 記錄應清晰且易於獲取。

6. 與材料和/或產品和/或化妝品分銷有關的文件的保留應符合國家要求。

Good Manufacturing Practice (GMP):

1. All cosmetic products must be produced in accordance with the Good Manufacturing Practice Guidelines for Cosmetics or equivalent

2. Local manufacturers are required to undergo regular inspections by NPRA’s GMP auditors; for foreign manufacturers, documentation demonstrating GMP compliance shall be provided as required by NPRA.

3. Standards equivalent to GMP:

(1) Good Manufacturing Practices for Pharmaceutical Products, World Health Organisation (WHO)

(2) Australian Code of Good Manufacturing Practice for Therapeutic GoodsSunscreen Products, Therapeutic Goods Administration (TGA)

(3) ISO Standard 22716: Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices

4. Documents required for Good Manufacturing Practice (GMP)

(1) Material specifications of the original packaging

.Material name

.Material Description

.Test parameters, acceptance limits

.Technical Drawings (if applicable)

.Special precautions such as storage and safety conditions (if necessary)

(2) Bulk, finished product specifications

.Product name

.Illustrate

.Physical properties

.Chemical analysis and/or microbiological analysis and their acceptance limits (if necessary)

.Storage conditions and safety precautions (if necessary)

(3) Production documents

(4) Main formula

.Product name, product code/number

.Expected Packaging Materials, Storage Conditions

.List of raw materials used

.List of equipment used

.Process controls and their limitations on processing and packaging (if applicable)

(5) Batch Production Record (BMR): A batch production record must be prepared for each batch of products.

.batch formula

.Brief description of the manufacturing process

.Lot number or code

.Start and end dates for processing and packaging

.Identification of major equipment lines or locations

.Cleaning records of equipment responsible for processing

.Process control and laboratory results such as pH and temperature test records

.Packaging line inspection record

.Any sampling performed during individual steps

.any investigation of a specific fault or discrepancy

.Inspection results of packaged and labelled products

(6) Quality control records: Records of each test, release or rejection of assay results for starting materials, intermediates, bulk products and finished products need to be maintained.

.Material identification

.Supplier name

.Date of receipt

.Original lot number (if available)

.Batch number

.Quality control number

.Receipt quantity

.Sampling date

.Quality Control Results

Product Information File (PIF):

1. CNH shall be responsible for providing all product information, certificates, documents and data required by NPRA.
PIFs can be in archival form (that is, a collection of paper records stored in a specific location) or in electronic format.

2. The file content contains the following points

(1) Administrative documents and product overview

.Product identity, name and address of manufacturer, assembler, importer and CNH

.Product Owner’s Letter of Authorization or Declaration and Contract Manufacturing (if applicable)

.Other relevant administrative documents, e.g. business license, company registration certificate

.Fragrance, name and code of ingredient and identity of supplier

.Outer and inner labels

.Consumer Information Flyer and Instructions for Use

.A document issued/endorsed by an accreditation body (indicating that it was manufactured in accordance with the Cosmetic GMP Guide or any equivalent guide)

.Batch Coding System/Key for Products

.Safety Statement (signed statement of opinion, including the name and qualifications of the safety assessor)

.Adverse effects on human health confirmed (summary)

.Summary Report of Product Efficacy Assessment

(2) Quality data of raw materials

.Specifications of Each Ingredient

.Analysis method corresponding to the specification of each component

.The name, address and declaration of compliance of the fragrance supplier

.Flavor materials (please specify the product name and code)

.Raw material safety data available in the supplier area: published data or reports from scientific committees such as the ASEAN Cosmetic Science Body (ACSB), the European Union Scientific Committee on Consumer Products (SCCP) or the U.S. Cosmetics Ingredient Review Committee (CIR).

(3) Quality data of finished products

.Qualitative and quantitative formulation of the product (INCI or other approved reference designation and corresponding ingredient concentration), which must state the function of each raw material/ingredient

.Manufacturer, assembler, packer’s name, country and address

.Summary of Manufacturing Process

.Provide more details about the manufacturing process, quality control and related manufacturing documentation as required by NPRA

.Standard for cosmetic microbiological control and chemical purity of cosmetic ingredients

.Analysis method for each inspection specification

.Stability test data/reports or stability assessments supporting expiration date

(4) Safety and efficacy data

.Signed safety assessment report of finished product to human health based on its composition, chemical structure and exposure level

.Safety Assessor Resume

.The latest compiled report of confirmed or documented adverse events or adverse effects on human health resulting from the use of the cosmetic product

3. Note: CNH should keep PIF at the address specified on the label for easy access by regulatory agencies, and it is recommended to keep it for at least 3 years after the product was last placed on the market.

Good Distribution Practice (GDP)

1. Importers and wholesalers must adhere to the principles of Good Distribution Practice (GDP).

2. The written description shall describe the different actions that may affect the quality of the material and/or product and/or cosmetic or distribution activity:

.Receipt and Check Delivery

.Storage, cleaning and maintenance of premises (including pest control)

.Record of storage conditions

.On-site inventory and cargo security in transit

.Pull records from saleable inventory

.Customer order record

.Returned materials and/or products and/or cosmetics, recall programs, etc.

3. These procedures shall be approved, signed and dated by authorized personnel.

4. Each action shall be recorded as it is carried out and shall be carried out in such a way that all significant activities or events can be traced.

5. Records should be legible and easily accessible.

6. Retention of documents related to the distribution of materials and/or products and/or cosmetics shall comply with national requirements.

【參考連結】

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/frequently-asked-questions-faqs-licensing.html

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口化妝品後,如果委託馬來西亞的經銷商銷售,經銷商需要化妝品營業許可證嗎?
假如化妝品有品質瑕疵的話,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 cosmetics and entrusts a distributor in Malaysia 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?

Evershine RD:

須以馬來西亞當地健康/化妝品公司通知持有人 (CNH)的名義申請,批發商必須申請健康/化妝品批發商許可證才能註冊並銷售其產品,許可證有效期為1年。
CNH應向發生國家藥品監督管理局 (NPRA)報告不良事件,無論報告的來源(消費者、醫療保健專業人員等)如何。
所有嚴重的不良事件應該報告。不要求報告非嚴重不良事件。
只要有理由懷疑化妝品可能是引起反應的原因,就必須報告所有嚴重的不良事件。

A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/

HLF-TW-85

各國化妝品登記法規問答集

接洽我們:
Email:kul4ww@evershinecpa.com

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