談印尼BPOM的產品註冊

BPOM其實就是印尼文的食品藥物管理局FDA的縮寫，主管印尼的食品飲料、保健食品(膳食補充品)、藥品、化妝品、醫療器材等產品業別。

其功能包括：
1).相關業別的政策、標準、程序與指標的訂定與修正更新。
2).相關業別的政策、標準、程序與指標的執行與監督。
3).產品測試與檢驗。
4).相關業別的製造、銷售與物流設施的檢查與監督。
5).相關業別產品的認證與核准。

以2021年計，保健食品的新註冊共有4,657項是所有類別中最少的，傳統藥品12,216項、新藥18,601項、食品飲料則計有141,002項，化妝品最多共有182,452項。

印尼認可的品質標準包括如下：

• ■ ASEAN Consultative Committee for Standards and Quality (ACCSQ)
• ■ Pacific Area Standard Congress (PASC)
• ■ Asia Pacific Laboratory Accreditation Cooperation (APLAC)
• ■ Codex Alimentarius Commission (CAC)
• ■ International Laboratory Accreditation Cooperation (ILAC)

基本上，向BPOM註冊食品飲料、保健食品、醫療器材與化妝品的原則程序很類似，都有線上註冊系統，一般需要提供的資料包括如下：

• ■ Company Documents: Single Business Identity Number (NIB), Company’s Tax ID (NPWP), Trade Business License (SIUP), Importer Identification Number (API), plus Medical Device Distribution License (IPAK) for medical devices.所以其實很明顯，這個系統必須要由當地進口商概念去填寫，差別只是各企業是要由自己的商業客戶(代理商/經銷商)去擔任這個進口商還是要由專業服務的第三方服務商去擔任這個進口商，第三方的好處，可瀏覽(外銷中第三方持證人代表人的趨勢)。
• ■ Administrative Documents: Letter of Authorization (LoA), Free Sales Certificate, GMP Certificate/ISO.當地進口商必須獲得出口方的授權文件即(LoA)。
• ■ Technical Documents: Dossier from Manufacturer.這部分會要由製造商提供，所以我們出口的品牌商/貿易商要很清楚代工廠願意提供這些技術資料，這也是為何另一說服代工廠願意配合的關鍵點會是雇用專業第三方服務商。

以保健食品註冊而言，通常產品可被區分為3種類別，分別為：

• Category 1: health supplements containing one or more of these materials: vitamin, mineral, carbohydrate, amino acid, protein, fat, or other materials in the form of isolate.此類別為單獨營養素的產品類別。
• Category 2: health supplements containing one or more of these materials: vitamin, mineral, carbohydrate, amino acid, protein, fat, other isolates, and other materials in the form of natural materials.此類別為複方成分的產品類別。
• Category 3: health supplements of categories 1 and 2 but with a claim of new preparation form, new dosage, new usage, and posology.產品有新製程、新劑型、新用途、新劑量等等者，則屬於此一類別。

以醫療器材註冊而言，遵循1190/MENKES/PER/VIII/2010-Regarding Medical Devices and Household Products法規，主要針對不含藥品的器材、設備、儀器及植入物等用於預防、診斷、治療、減緩痛苦、可讓病患恢復或矯正等功能者，另依據東協醫材規範ASEAN Medical Device Directive (AMDD)，其分類有4類，分別為：

• Class 1: Low Risk – These are devices or equipment that don’t cause any serious physical harm if they malfunction. Examples include bandages and weighing scales.此類別為如果失效不會產生傷害者。
• Class 2: Low to Moderate Risk – These are devices or equipment that may cause a significant but not serious impact on a person’s physical health. Examples include pregnancy self-testing and surgical masks.此類別為可產生明顯但不嚴重的生理健康之影響者。
• Class 3: Moderate to High Risk –These are devices or equipment that could impact a person’s physical health but don’t lead to serious damage if they malfunction. Class-3 devices are similar to class-2 devices. However, a more thorough evaluation is required. Examples include condoms and contact lenses.此類別為可產生明顯但不嚴重的生理健康之影響，但比二級需要更多的評估者。
• Class 4: High Risk – These are devices or equipment that result in serious physical harm, including death, when they are misused or malfunction. Examples include pacemaker and HIV blood donor screening.此類別當失效或誤用時會對人體生理健康產生傷害甚至死亡者。

以化妝品註冊而言，化妝品一般會被忽略要註冊，但其實在印尼所有化妝品，甚至洗漱用品都要進行註冊，而且是每種色調都要註冊，此外，化妝品/保養品的標籤、廣告、功能宣稱都是被管理的，此外成分(包括色素)的規範也很嚴格，所以不要輕忽事先合規的重要性。

依據經驗，通常化妝品註冊容易犯錯的包括：第一、忽略進口商的註冊，許多當地人都未認知經銷化妝品是必須註冊的；第二、對在印尼的自身產品喪失控制權，由於未理解印尼規範全印尼你的化妝品僅可有一個法規(面對BPOM)的代理人(又稱持證人)，若經銷商非你的獨家代理人，那就危險了，所以我們一般建議要找第三方持證人；第三、找了非可信賴的夥伴，由於產品註冊需要全配方登記，若夥伴不可信任，則可能外洩配方給當地代工廠；第四、錯估化妝品註冊的複雜性，所以需要預估註冊所需要的時間，以免造成商機的延誤。

在家庭清潔用品(HHP)方面，則是根據印尼MOH的Number 1190/Menkes/Per/VIII/2010規範執行，其行銷執照，與醫療器材同屬一類，包括針對人類健康相關、寵物健康相關的清潔用品/用具/物質等皆屬之。 其分類如下：

• Class I (low risk) : This class includes household product which not cause any serious effect such as irritation, corrosive and carcinogenic. Household products under class I e.g. cotton and tissue. The evaluation process would take about 45 working days exclude period for determining the class.此類別不會產生任何刺激、腐蝕及致癌性，此類別的評估約需45工作天。
• Class II (medium risk) : Includes household product which cause irritation, corrosive but doesn’t cause serious effect like carcinogenic. Before distributing, the product should be registered by enclosing the result of laboratory test and will take approximately 80 working days. Products which are categorized under class II such as detergent and alcohol.此類別會產生刺激或腐蝕但無致癌性，必須經過實驗室測試通過者始能註冊，約需要80個工作天。
• Class III (high risk): This class includes household product which contains pesticides such as repellent and it can cause serious effect like carcinogenic. Along with registration, applicant should enclosed result of laboratory test and should already acquire confirmation from Pesticide Commission under Ministry of Agriculture.  The registration will take about 100 working days.此類別可能含有殺蟲劑會產生致癌性者，則必須有實驗室測試報告及農業部殺蟲劑委員會審核過才能註冊，一般會需要100個工作天。

家庭清潔用品行銷執照的步驟基本上就是2個主要步驟，一是進行產品分類(如前述)，此分類是由官方執行並同時付規費(non-tax state revenue，PNBP)，此步驟約需17個工作天；第二步則是評估步驟，包括安全評估、效力評估、品質評估，評估後有可能3種結果，分別是核准行銷執照、補件通知及核駁函等。 所需文件如下：

• ■ Filled application form
• ■ Letter of Appointment
• ■ Certificate of Free Sale (CFS)
• ■ Certificate of ISO 9001
• ■ Business License and tax ID
• ■ Statement letter of willingness to trasnfer distributor rights if there is another more eligible distributor
• ■ Statement letter of willingnes to meet safety requirements
• ■ Detail ingredients and production process
• ■ Specification of raw materials and packaging
• ■ Specification of stability studies
• ■ Using instruction