印尼政府加强医疗器械注册的管理

随着2017年第60号法规的执行，在2018年印尼政府对医疗器械注册加强了管理。

之前，进口医疗器械的合规性是在清关时由海关官员确认的。现在健康部被授权在医疗器械经销商处通过检查给予确认（即，过境后监管）。任何没有注册的器械可能被再出境或销毁，产生的费用由进口商承担。并且，拥有注册不正确的器械的经销商的经销证可能被暂停。预计这场行动会提高医疗器械注册的合规性。

Indonesia Tightens Enforcement of MedicalDevice Licensing

With the implementation of RegulationNo. 60, 2017 on February 1st, 2018 the Indonesia governmenttightened enforcement of medical device licensing requirements.

Formerly, compliance for imported medicaldevices was confirmed during the customs clearance process by Customs andExcise Department officials. Now the Ministry of Health is authorized to extendconfirmation through inspection at medical device distributors (AKA,Post-Border monitoring).

Any devices without proper licensing mayresult in re-exportation or destruction at the importers expense. Further,distributors in possession of improperly licensed devices may have theirDistribution License suspended.  The move is expected to increasecompliance with the medical device registration requirements.

印尼电子目录系统介绍

希望在印尼取得销售成功，可以考虑电子目录公告作为一个重要方法。这个在线采购系统的建立是为了使政府采购透明化、防止腐败，包括被印尼政府物品和服务采购组织 （LKPP）管理的公立医院。

虽然从2013年启动，但使各方理解到其对销售的影响花了些时间。起初，看起来公司对参加这个自愿系统比较勉强。加入的后来获得了很好的销售业绩，以至于现在他们急切希望把其所有产品都列入电子目录系统。

在进口医疗器械注册后，持证方可以申请健康部举行电子目录公告会议，在该会议上将谈判公告价格。该会议的一个要素是提供来自至少一个批次的商业发票。价格谈判是在落地发票成本基础上补加一个百分比，通常在25%到35%之间。这个申请过程不收取政府申请费，但是举行电子目录公告会议的排队时间可能是6个月甚至更久。

实行优化的价格策略对成功销售给公立医院非常关键。电子目录系统也增加了在印尼独立持证的重要性，因为在价格框架下仅有很小的区域分销商利润空间。

Indonesia’s e-Catalogue System Overview

An important, new consideration to salessuccess in Indonesia is the e-Catalogue listing. This on-line procurementsystem was established to bring transparency and prevent corruption ingovernment purchases, including public hospitals, as administered by theIndonesian Government Goods and Services Procurement Organization (LKPP).

Although initiated in 2013, it took partiessome time to understand the implication on sales. At first, companies seemedweary to participate in the voluntary system. Those that did enjoyed strongsales results and so now there is a rush for all to be listed.

After an Import License for a device isissued, the License Holder can apply to the Ministry of Health for ane-Catalogue listing meeting at which the listing price will be negotiated. Arequired element for the meeting is a commercial invoice from at least onedevice shipment to Indonesia. Price negotiations are for a percentage mark-upfrom the invoiced landed cost typically between 25% to 35%. There is nogovernment application fee for the application process, but the queue can be 6months or longer for the price negotiation meeting.

Implementing an optimal pricing strategywill be critical to successful public hospital sales. The e-Catalogue systemalso increases the importance of independent license holding in Indonesiabecause there is little room for regional dealer margin under the price scheme.

麦祥印尼咨询服务有限公司（PT Medwheat Indonesia）是麦祥国际全球分支之一，是中国第一家全资驻印度尼西亚的医疗器械技术咨询服务公司，公司可以帮助中国企业进行Izin Edar申报（有源/无源/IVD注册），可以为中国企业提供从印尼语翻译、注册审评沟通、经销商介绍、注册证持证等一条龙服务。

麦祥印尼愿意以优质的精品服务，帮助中国医疗器械企业稳步“一带一路”。