在印度尼西亚，政府为了能够更好的去应对当前的疫情，印尼卫生部通过官网对外做出宣布，一些医疗设备或家庭设备的许可证审批工作可以优先进行。

眼下新冠肆虐全国，印度尼西亚政府已将目前状态改为“COVID-19紧急响应”。为了更快更有效对应对这轮瘟疫，政府当下已对与新冠相关的几款产品提供了优先处理。

政府优先处理的产品包括：

1. 手术服 (口罩、个人防护装置、医用护目镜)；

2. 液体化学消毒剂 / 高级消毒剂及 (消毒剂、擦手剂)；

3. 外科手套 (无菌手套)；

4. 患者检查手套 (检查手套)；

5. 医用电子体温计 (温度计)；

6. 通风设备；

7. 运输培养基；

8. 微生物标本采集和运输装置 (Dacron棉签)；

9. 杀菌剂 (洗手液)。

除上文提到的产品的注册会加速外，卫生部同时为印尼急需的医疗器械开启了“特殊审批”通道（SAS）。按照印尼卫生部2014第51号令关于通过“特殊审批”通道进口医疗器械，SAS允许政府可以直接进口医疗器械，无需先获得进口分销许可证。

而这些想要直接通过SAS进入印尼的医疗器械，必须满足以下的条件：

a. 为社会和国家提供最大收益；

b. 关注国家需求和储备；

c. 满足安全和收益标准和要求；

d. 在健康领域支持政府政策；

e. 来自官方渠道；

f. 稀缺性；

g. 没有类似产品可以获得；

h. 用于偶发使用，而非常规使用；

i. 非商业用途。

SAS许可分为两种类型：SAS捐赠许可和SAS非捐赠许可。

SAS捐赠许可仅能用于健康服务需求、健康领域的政府项目、研究开发、防止传染病的爆发流行。卫生部是可以接受这些产品的SAS请求的。

SAS非捐赠许可仅用于医生申请、在健康领域的政府项目、研究开发、教育培训、国家级健康展的特殊使用需求。现今，被卫生部批准的SAS非捐赠许可只有新冠COVID-19检验试剂盒。

获得SAS许可的费用为印尼盾IDR 750,000（约合350RMB）。在新冠疫情期间，如果需要的文件都齐全，市场授权和SAS许可的申请几个小时内就可以完成。

The Ministry of Health (MoH) Indonesia announced through their website that a number of medical devices or household devices can be prioritized or accelerated for license approval for the purpose of preparedness handling of COVID-19.

Due to the current pandemic situation caused by the novel coronavirus, better known as COVID-19, the government of Indonesia has responded by changing its current status to “COVID-19 Emergency Response”. To facilitate an effective response to this pandemic, the government is providing some leeway with regard to the process of registering several products that are indispensable during this pandemic.

The Ministry of Health (MoH) announced through the registration website a list of medical devices or household devices for which the approval license is being prioritized or accelerated for the sake of preparedness handling of COVID-19, including:

1. Surgical apparel (masks, personal protective equipment, medical goggles);

2. Liquid chemical sterilant/high level disinfectant (disinfectant, hand rub, hand scrub);

3. Surgeons’ gloves (sterile gloves);

4. Patient examination gloves (examination gloves);

5. Clinical electronic thermometer (thermometer);

6. Ventilator;

7. Transport culture medium;

8. Microbiological specimen collection and transport device (Dacron swab);

9. Antiseptic (hand sanitizer).

In addition to the acceleration of new registration of the products mentioned above, the MoH has also issued a special access scheme (SAS) giving special access to medical devices that are urgently needed in Indonesia. The SAS allows the government to bypass the need for a distribution permit for importation, according to the Regulation of the Minister of Health of the Republic of Indonesia Number 51 of 2014 concerning the importation of medical devices through the SAS.

Medical devices that can be entered through the SAS must meet the following criteria:

a. provides maximum benefits for society and the country;

b. pays attention to national needs and stock;

c. meets safety and benefit standards and requirements;

d. supports government policies in the health sector;

e. is from an official source;

f. has scarce availability;

g. there are no similar products available;

h. is incidental and not for regular use, and/or;

i. is not for commercial purposes.

SAS licenses are divided into two types: namely SAS Donations and SAS Non-Donation.

SAS Donations can only be intended for the needs of health services, government programs in the field of health, research and development, and/or prevention of outbreaks, epidemics, or disasters. The MoH accepts SAS requests for products as mentioned above.

Whereas SAS Non-Donation can only be intended for special use needs at the request of doctors, government programs in the field of health, research and development, education and training, and/or national-scale health exhibitions. For now, the only SAS Non-Donation license approved by the MoH is that for a COVID-19 Test Kit.

The fee for obtaining the SAS permit is IDR 750,000. During this pandemic the application for a marketing authorization and SAS permit can be processed within hours if the required documents are completed.