谈印尼BPOM的产品注册

BPOM其实就是印尼文的食品药物管理局FDA的缩写，主管印尼的食品饮料、保健食品(膳食补充品)、药品、化妆品、医疗器械等产品业别。

其功能包括：
1).相关业别的政策、标准、程序与指标的订定与修正更新。
2).相关业别的政策、标准、程序与指标的执行与监督。
3).产品测试与检验。
4).相关业别的制造、销售与物流设施的检查与监督。
5).相关业别产品的认证与核准。

以2021年计，保健食品的新注册共有4,657项是所有类别中最少的，传统药品12,216项、新药18,601项、食品饮料则计有141,002项，化妆品最多共有182,452项。

印尼认可的品质标准包括如下：

• ■ 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注册食品饮料、保健食品、医疗器械与化妆品的原则程序很类似，都有线上注册系统，一般需要提供的资料包括如下：

• ■ 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.所以其实很明显，这个系统必须要由当地进口商概念去填写，差别只是各企业是要由自己的商业客户(代理商/经销商)去担任这个进口商还是要由专业服务的第三方服务商去担任这个进口商，第三方的好处，可浏览(外销中第三方持证人代表人的趋势)。
• ■ Administrative Documents: Letter of Authorization (LoA), Free Sales Certificate, GMP Certificate/ISO.当地进口商必须获得出口方的授权文件即(LoA)。
• ■ Technical Documents: Dossier from Manufacturer.这部分会要由制造商提供，所以我们出口的品牌商/贸易商要很清楚代工厂愿意提供这些技术资料，这也是为何另一说服代工厂愿意配合的关键点会是雇用专业第三方服务商。

以保健食品注册而言，通常产品可被区分为3种类别，分别为：

• 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.此类别为单独营养素的产品类别。
• 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.此类别为复方成分的产品类别。
• Category 3: health supplements of categories 1 and 2 but with a claim of new preparation form, new dosage, new usage, and posology.产品有新制程、新剂型、新用途、新剂量等等者，则属于此一类别。

以医疗器械注册而言，遵循1190/MENKES/PER/VIII/2010-Regarding Medical Devices and Household Products法规，主要针对不含药品的器材、设备、仪器及植入物等用于预防、诊断、治疗、减缓痛苦、可让病患恢复或矫正等功能者，另依据东协医材规范ASEAN Medical Device Directive (AMDD)，其分类有4类，分别为：

• 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.此类别为如果失效不会产生伤害者。
• 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.此类别为可产生明显但不严重的生理健康之影响者。
• 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.此类别为可产生明显但不严重的生理健康之影响，但比二级需要更多的评估者。
• 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.此类别当失效或误用时会对人体生理健康产生伤害甚至死亡者。

以化妆品注册而言，化妆品一般会被忽略要注册，但其实在印尼所有化妆品，甚至洗漱用品都要进行注册，而且是每种色调都要注册，此外，化妆品/保养品的标籤、广告、功能宣称都是被管理的，此外成分(包括色素)的规范也很严格，所以不要轻忽事先合规的重要性。

依据经验，通常化妆品注册容易犯错的包括：第一、忽略进口商的注册，许多当地人都未认知经销化妆品是必须注册的；第二、对在印尼的自身产品丧失控制权，由于未理解印尼规范全印尼你的化妆品仅可有一个法规(面对BPOM)的代理人(又称持证人)，若经销商非你的独家代理人，那就危险了，所以我们一般建议要找第三方持证人；第三、找了非可信赖的夥伴，由于产品注册需要全配方登记，若夥伴不可信任，则可能外洩配方给当地代工厂；第四、错估化妆品注册的复杂性，所以需要预估注册所需要的时间，以免造成商机的延误。

在家庭清洁用品(HHP)方面，则是根据印尼MOH的Number 1190/Menkes/Per/VIII/2010规范执行，其行销执照，与医疗器械同属一类，包括针对人类健康相关、宠物健康相关的清洁用品/用具/物质等皆属之。 其分类如下：

• 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.此类别不会产生任何刺激、腐蚀及致癌性，此类别的评估约需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.此类别会产生刺激或腐蚀但无致癌性，必须经过实验室测试通过者始能注册，约需要80个工作天。
• 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.此类别可能含有杀虫剂会产生致癌性者，则必须有实验室测试报告及农业部杀虫剂委员会审核过才能注册，一般会需要100个工作天。

家庭清洁用品行销执照的步骤基本上就是2个主要步骤，一是进行产品分类(如前述)，此分类是由官方执行并同时付规费(non-tax state revenue，PNBP)，此步骤约需17个工作天；第二步则是评估步骤，包括安全评估、效力评估、品质评估，评估后有可能3种结果，分别是核准行销执照、补件通知及核驳函等。 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