印尼医疗器材登记法规问题集
Email:jkt4ww@evershinecpa.com
或
印尼永辉BPO有限公司
Jakarta time zone:
The Engaging Manager Cindy Luo, Indonesia citizenship, speaks English, Bahasa and Chinese
或
China Time Zone:
联络人: 朱键彰 Jerry Chu 协理
手机:+886-939-357735
skype: jc0096
wechat: jc0096
电话:+886-2-2717-0515 分机:103 (might work from home
HLF-ID-10
请问印尼对于医疗器材的归类方式为何?它的正式名称为何?
不同归类管理强度有何差异?它的政府管辖机构为何?网页?
What are the categories of medical devices in Indonesia? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?
Evershine RD:
在印尼,医疗器材由卫生部(MoH) 监管,负责上市前和上市后评估、标准化、立法和良好生产规范 (GMP) 认证。
在进口之前,医疗器材和 体外诊断医疗器材(IVD) 必须获得卫生部颁发给当地特许经销商的註册号和产品许可证。
1. 医疗器材:用于预防、诊断、治癒和缓解疾病、治疗病人、恢復人类健康和/或形成结构、改善身体功能的仪器、设备、机器和/或植入物,但不包含药物。医疗器材可以单独或组合用于人类,具有以下一种或多种用途:
.诊断、预防、监测、治疗或减少疾病。
.疾病状况的诊断、监测、治疗、减轻或补偿。
.调查、替换、修改、解剖支持或生理过程。
.支持或维持生命。
.阻碍受精。
.医疗器材消毒剂。
.通过对标本和人体进行体外测试,为医疗或诊断目的提供信息。
2. 体外诊断医疗器材:试剂、校准物、对照材料、试剂盒、仪器、装置或系统,单独或结合使用在检查任何体外标本(包括人类来源的血液或组织)的设备或系统,目的主要是为了提供以下一种或多种讯息:
.生理或病理状况或先天性异常。
.确定血液或组织捐献者与潜在接受者的安全性和适用性。
.监测治疗的状态。
3. 治疗性有源医疗器材:有源医疗器材,单独或与其他医疗器材组合使用,支持、修改、替换或改善生物功能或结构,治疗或减少疾病、伤害或残疾。
4. 诊断有源医疗器材:有源医疗器材,单独或与其他医疗器材结合使用,检测、诊断、监测或帮助治疗生理状况、健康水平、疾病或先天性残疾。
5. 活动医疗器材:使用有源医疗器材以外的能源运行的医疗器材。
6. 侵入性医疗器材:通过身体开口/表面全部/部分进入身体的医疗器材。
7. 无创医疗器材:不会通过身体开口/身体表面全部/部分穿透身体的医疗器材。
医疗器材分类:医疗器材是根据使用这些医疗器材过程中产生的风险进行分类的,基于这些风险,医疗器材分为以下四类
1. A类:低风险,例如:手术器材、手术手套、氧气面罩等。
2. B类:低到中等风险,例如:压脉带、蒸汽消毒器等。
3. C类:中到高风险,例如:身高监测器、X光机等。
4. D类:高风险,例如:高风险心脏支架、心脏起搏器等。
体外诊断医疗器材分类:风险等级分类受个体风险因素和公共卫生风险的影响,分为以下四类
1. A类:低个人风险和低公共卫生风险,例如:临床化学分析仪、胆固醇测试、尿酸测试等。
2. B类:中等个人风险和低公共卫生风险,例如:验孕棒等。
3. C类:高个人风险和中等公共卫生风险,例如:自用血糖检测试剂盒、HLA分型测定、PSA筛查等。
4. D类: 高个人风险和高公共卫生风险,例如:捐血者 HIV 筛查、HIV 血液诊断等。
In Indonesia, medical devices are regulated by the Ministry of Health (MoH) responsible for pre-market and post-market assessment, standardization, legislation and Good Manufacturing Practice (GMP) certification.
Prior to importation, medical devices and in vitro diagnostic medical devices (IVDs) must obtain a registration number and a product license issued by the Ministry of Health to the local franchised distributor.
1. Medical Devices: Instruments, devices, machines and/or implants used to prevent, diagnose, cure and alleviate disease, treat patients, restore human health and/or form structures, improve bodily functions, but do not include drugs.
Medical devices can be used in humans, alone or in combination, for one or more of the following purposes:
.Diagnose, prevent, monitor, treat or reduce disease.
.Diagnosis, monitoring, treatment, mitigation or compensation of a disease condition.
.Investigation, replacement, modification, anatomical support or physiological process.
.Support or sustain life.
.Block fertilization.
.Medical device disinfectant.
.Provide information for medical or diagnostic purposes by performing in vitro testing on specimens and humans.
2. In vitro diagnostic medical device: reagents, calibrators, control materials, kits, instruments, devices or systems, used alone or in combination, for the examination of any in vitro specimen (including blood or tissue of human origin), primarily for the purpose of To provide one or more of the following information:
.Physiological or pathological conditions or congenital abnormalities.
.Determine safety and suitability for blood or tissue donors and potential recipients.
.Monitor the status of treatment.
3. Therapeutic Active Medical Devices: Active medical devices, used alone or in combination with other medical devices, to support, modify, replace or improve biological function or structure, to treat or reduce disease, injury or disability.
4. Diagnostic Active Medical Devices: Active medical devices, used alone or in combination with other medical devices, to detect, diagnose, monitor or assist in the treatment of physical conditions, fitness levels, diseases or congenital disabilities.
5. Active medical device: Medical device that operates with energy other than active medical device.
6. Invasive Medical Devices: Medical devices that enter the body wholly/partly through an opening/surface of the body.
7. Non-invasive medical devices: Medical devices that do not penetrate the body fully/partly through body openings/body surfaces.
Medical device classification: Medical devices are classified according to the risks arising from the use of these medical devices. Based on these risks, medical devices are divided into the following four categories
1. Class A: low risk, such as: surgical equipment, surgical gloves, oxygen masks, etc.
2. Class B: Low to moderate risk, eg: cuffs, steam sterilizers, etc.
3. Class C: Moderate to high risk, such as: height monitors, X-ray machines, etc.
4. Class D: high risk, such as: high risk cardiac stents, pacemakers, etc.
Classification of in-vitro diagnostic medical devices: The classification of risk levels is influenced by individual risk factors and public health risks, and is divided into the following four categories
1. Class A: Low personal risk and low public health risk, such as: clinical chemistry analyzers, cholesterol tests, uric acid tests, etc.
2. Class B: Moderate personal risk and low public health risk, such as pregnancy test sticks, etc.
3. Class C: High personal risk and moderate public health risk, such as self-use blood glucose testing kits, HLA typing, PSA screening, etc.
4. Class D: High personal risk and high public health risk, eg: HIV screening of blood donors, HIV blood diagnosis, etc.
【参考连结】
http://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Klasifikasi.pdf
HLF-ID-20
外国公司要到印尼销售医疗器材,无论设100%子公司或分公司,需要在公司登记时取得营业特许证?
假如要,其必要条件是什麽?所需文件及申请程序为何?网页?
If a foreign company wants to sell medical devices in Indonesia, 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:
需要,须以印尼当地公司名义取得医疗器材经销许可证(DAK)。
医疗器材经销商许可证由卫生部颁发,医疗器材的经销/交付可以从医疗器材经销商所在的位置在整个印度尼西亚进行。
医疗器材经销商和分支机构经销商可以根据所拥有的设施和人力资源,按照批准的产品组来经销医疗器材,产品分为5组:
1. 辐射电子医疗器材
2. 非辐射电子医疗器材
3. 无菌非电子医疗器材
4. 非无菌电子医疗器材
5. 体外诊断医疗器材
医疗器材经销商必须满足以下要求:
1.商业行为者是有限责任公司或合作社形式的非个体商业行为者
2.非税收国家收入的支付证明(PNBP)
3.技术人员资料
4.业务参与者执行标准的持续时间为 OSS 申请获得批准后的 1年
5.技术负责人有CDAKB培训证书
6.业务运营计划
7.经销产品类型清单
8.产品说明书
9.拥有的人力资源数据
10.自有存储设施
.建筑物的佈局和照片
.仓库设备清单
11.自有或与持有经销电子医疗器材和/或体外诊断仪器经销许可证的经销商或製造商合作的技术人员。
医疗器材经销分公司特殊要求
1. 技术负责人有CDAKB培训证书
2. 业务运营计划
3. 经销产品类型清单
4. 产品手册、拥有的人力资源数据
5. 自有存储设施
6. 建筑物的佈局和照片
7. 根据政府规定为支持经营活动而製定的固定程序
8. 仓库设备清单
9. 技术人员由他们自己拥有或与其中央经销商合作,用于医疗和/或电子医疗设备
注意
1.医疗器材经销和分支机构的设施必须具有符合产品要求的建筑物和设施,其办公室、仓库和/或车间地址不能是虚拟地址,并且必须符合标准。
2. 医疗器材经销商或分公司必须具有符合运营需要的组织结构,配备公司结构图,并明确说明每个人员的职责和权限,必须有 1名技术人员为印度尼西亚国籍,并符合有能力、被授权、有责任,使配送系统运行良好,确保医疗器材的安全、质量,根据下表具有最低教育背景。
辐射电子医疗设备
.DIII/S1:药剂师/药剂师
.DIII/DIV :电子医学
.S1:电气工程
.DIII/DIV 工程:放射诊断和放射治疗
.S1:生物医学工程
.S1:医学物理
非辐射电子医疗设备
.DIII/S1:药剂师/药剂师
.DIII/DIV :电子医学
.S1:电气工程
.DIII/DIV 工程:放射诊断和放射治疗
.S1:生物医学工程
.DIII/S1信息学工程(专门用于医疗设备软件)
.DIII 折射光学(尤其是眼保健设备)
.DIII 牙科工程(专门用于牙科设备)
无菌非电子医疗器材
.DIII/S1:药剂师/药剂师
一般医疗器材
.PJT教育
3. 技术负责人不得兼任董事/委员,如果公司拥有其他生产或经销设施,则必须有不同的技术负责人。
4. 技术负责人必须接受良好医疗器材流通方式(CDAKB)的培训,并有CDAKB培训证书证明。
5. 技术负责人需要为全职工作者,如果技术负责人暂时不能履行职责(如病假、产假等) 经销商和分支机构必须指定临时替代人有背景的技术负责人。
6. 必须有公司与技术负责人的合作协议,并经公证人认证。
7. 如果经销商或经销商的分支机构拥有超过 1个仓库位置,则必须在每个位置都有一名具有教育背景的仓库负责人。
8. 必须有一个培训计划,以提高人力资源管理医疗器材的能力。
9. 处理医疗设备的人员处于高风险和/或可能导致不良影响,例如感染和过敏,需要特殊培训。
10. 必须拥有能够安装、维护和维修分佈式医疗器材的称职且经验丰富的技术人员,并在电气工程、机械或汽车领域具有最低限度的 SMK 教育并全职工作时间
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
The Medical Device Distributor License is issued by the Ministry of Health, and the distribution/delivery of medical devices can take place throughout Indonesia from the location where the Medical Device Distributor is located.
Medical Device Distributors and Branch Distributors can distribute medical devices according to the facilities and human resources they have, according to approved product groups, which are divided into 5 groups:
1. Radiation electronic medical device
2. Non-radiating electronic medical devices
3. Sterile non-electronic medical devices
4. Non-sterile electronic medical devices
5. In vitro diagnostic medical device
Medical device distributors must meet the following requirements:
1. Business actors are non-individual business actors in the form of limited liability companies or cooperatives
2. Proof of payment of non-tax state income (PNBP)
3. Technical staff information
4. The duration of the implementation of the criteria by business participants is 1 year after the OSS application is approved
5. The technical person in charge has CDAKB training certificate
6. Business Operations Plan
7. List of Product Types Distributed
8. Product manual
9. Owned HR data
10. Own storage facilities
. Building layout and photos
. List of warehouse equipment
11. Technicians who own or cooperate with distributors or manufacturers who hold a license to distribute electronic medical devices and/or in vitro diagnostic instruments.
Special requirements for medical device distribution branches
1. Technical leaders have CDAKB training certificate
2. Business operation plan
3. List of product types to be distributed
4. Product manuals, HR data owned
5. Own storage facilities
6. Layout and photos of the building
7. Established procedures in accordance with government regulations to support business activities
8. Warehouse Equipment List
9. Technicians owned by themselves or in cooperation with their central distributor for medical and/or electro-medical device
Notice
1. Facilities of medical device distribution and branch offices must have buildings and facilities that meet product requirements, whose office, warehouse, and/or workshop addresses cannot be virtual addresses, and must be compliant.
2. Medical device dealers or branches must have an organizational structure that meets operational needs, equipped with a company structure chart, and clearly explain the responsibilities and authorities of each person.
There must be 1 technician who is Indonesian nationality, and has the ability and ability to be accepted. Authorized, responsible, make the distribution system work well, ensure the safety and quality of medical device, have a minimum educational background according to the following table.
Radiation electronic medical device
. DIII/S1: Pharmacist/Pharmacist
. DIII/DIV: Electromedicine
. S1: Electrical Engineering
. DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
. S1: Biomedical Engineering
. S1: Medical Physics
Non-radiating electronic medical device
. DIII/S1: Pharmacist/Pharmacist
. DIII/DIV: Electromedicine
. S1: Electrical Engineering
. DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
. S1: Biomedical Engineering
. DIII/S1 Informatics Engineering (specifically for medical device software)
. DIII refractive optics (especially eye care devices)
. DIII Dental Engineering (specialized for dental equipment)
Sterile Non-Electronic Medical Devices
. DIII/S1: Pharmacist/Pharmacist
General medical device
. PJT Education
3. The technical leader shall not be a director/commissioner, if the company has other production or distribution facilities, there must be a different technical leader.
4. The person in charge of technology must be trained on the Good Circulation of Medical device (CDAKB), and have a CDAKB training certificate to prove it.
5. The technical person in charge needs to be a full-time worker. If the technical person in charge is temporarily unable to perform his duties (such as sick leave, maternity leave, etc.), the dealers and branches must appoint a temporary substitute for the technical person in charge with background.
6. There must be a cooperation agreement between the company and the technical director, which must be certified by a notary public.
7. If a dealer or a dealer’s branch has more than 1 warehouse location, there must be an educated warehouse manager at each location.
8. There must be a training program in place to improve the human resource’s ability to manage medical device.
9. Persons handling medical device are at high risk and/or may cause adverse effects, such as infections and allergies, requiring special training.
10. Must have a competent and experienced technician capable of installing, maintaining and repairing distributed medical devices with a minimum SMK education and full-time working hours in electrical engineering, mechanics or automotive
【参考连结】
http://regalkes.kemkes.go.id/informasi_alkes/PERMENKES%20No%201191%20Tahun%202010%20Tentang%20Penyalur%20Alat%20Kesehatan.pdf
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-25
HLF-ID-30
外国公司要到印尼销售医疗器材,可以指派印尼公司担任营业代理人销售吗?
担任营业代理人,其必要条件是什麽?所需文件及申请程序为何?外国公司与营业代理人的产品责任为何?网页?
If a foreign company wants to sell medical devices in Indonesia, can it assign a Indonesia 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,须以印尼当地公司名义取得医疗器材经销许可证(DAK)。
医疗器材经销商许可证由卫生部颁发,医疗器材的经销/交付可以从医疗器材经销商所在的位置在整个印度尼西亚进行。医疗器材经销商和分支机构经销商可以根据所拥有的设施和人力资源,按照批准的产品组来经销医疗器材,产品分为5组:
1. 辐射电子医疗器材
2. 非辐射电子医疗器材
3. 无菌非电子医疗器材
4. 非无菌电子医疗器材
5. 体外诊断医疗器材
医疗器材经销商必须满足以下要求:
1.商业行为者是有限责任公司或合作社形式的非个体商业行为者
2.非税收国家收入的支付证明(PNBP)
3.技术人员资料
4.业务参与者执行标准的持续时间为 OSS 申请获得批准后的 1年
5.技术负责人有CDAKB培训证书
6.业务运营计划
7.经销产品类型清单
8.产品说明书
9.拥有的人力资源数据
10.自有存储设施
.建筑物的佈局和照片
.仓库设备清单
11.自有或与持有经销电子医疗器材和/或体外诊断仪器经销许可证的经销商或製造商合作的技术人员。
医疗器材经销分公司特殊要求
1. 技术负责人有CDAKB培训证书
2. 业务运营计划
3. 经销产品类型清单
4. 产品手册、拥有的人力资源数据
5. 自有存储设施
6. 建筑物的佈局和照片
7. 根据政府规定为支持经营活动而製定的固定程序
8. 仓库设备清单
9. 技术人员由他们自己拥有或与其中央经销商合作,用于医疗和/或电子医疗设备
注意
1.医疗器材经销和分支机构的设施必须具有符合产品要求的建筑物和设施,其办公室、仓库和/或车间地址不能是虚拟地址,并且必须符合标准。
2. 医疗器材经销商或分公司必须具有符合运营需要的组织结构,配备公司结构图,并明确说明每个人员的职责和权限,必须有 1名技术人员为印度尼西亚国籍,并符合有能力、被授权、有责任,使配送系统运行良好,确保医疗器材的安全、质量,根据下表具有最低教育背景。
辐射电子医疗设备
.DIII/S1:药剂师/药剂师
.DIII/DIV :电子医学
.S1:电气工程
.DIII/DIV 工程:放射诊断和放射治疗
.S1:生物医学工程
.S1:医学物理
非辐射电子医疗设备
.DIII/S1:药剂师/药剂师
.DIII/DIV :电子医学
.S1:电气工程
.DIII/DIV 工程:放射诊断和放射治疗
.S1:生物医学工程
.DIII/S1信息学工程(专门用于医疗设备软件)
.DIII 折射光学(尤其是眼保健设备)
.DIII 牙科工程(专门用于牙科设备)
无菌非电子医疗器材
.DIII/S1:药剂师/药剂师
一般医疗器材
.PJT教育
3. 技术负责人不得兼任董事/委员,如果公司拥有其他生产或经销设施,则必须有不同的技术负责人。
4. 技术负责人必须接受良好医疗器材流通方式(CDAKB)的培训,并有CDAKB培训证书证明。
5. 技术负责人需要为全职工作者,如果技术负责人暂时不能履行职责(如病假、产假等) 经销商和分支机构必须指定临时替代人有背景的技术负责人。
6. 必须有公司与技术负责人的合作协议,并经公证人认证。
7. 如果经销商或经销商的分支机构拥有超过 1个仓库位置,则必须在每个位置都有一名具有教育背景的仓库负责人。
8. 必须有一个培训计划,以提高人力资源管理医疗器材的能力。
9. 处理医疗设备的人员处于高风险和/或可能导致不良影响,例如感染和过敏,需要特殊培训。
10. 必须拥有能够安装、维护和维修分佈式医疗器材的称职且经验丰富的技术人员,并在电气工程、机械或汽车领域具有最低限度的 SMK 教育并全职工作时间
责任
1. 产品许可证持有人必须负责任何医疗器材、体外诊断医疗器材销售的产品责任。
2. 任何通过 OEM 生产的医疗器材、体外诊断医疗器除了产品许可证持有人负有责任,产品所有者也有责任。
3. 任何委託生产的医疗器材、体外诊断医疗器材除了产品许可证持有人负有责任,受委託的製造商也有责任。
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
The Medical Device Distributor License is issued by the Ministry of Health, and the distribution/delivery of medical devices can take place throughout Indonesia from the location where the Medical Device Distributor is located. Medical Device Distributors and Branch Distributors can distribute medical devices according to the facilities and human resources they have, according to approved product groups, which are divided into 5 groups:
1. Radiation electronic medical device
2. Non-radiating electronic medical devices
3. Sterile non-electronic medical devices
4. Non-sterile electronic medical devices
5. In vitro diagnostic medical device
Medical device distributors must meet the following requirements:
1. Business actors are non-individual business actors in the form of limited liability companies or cooperatives
2. Proof of payment of non-tax state income (PNBP)
3. Technical staff information
4. The duration of the implementation of the criteria by business participants is 1 year after the OSS application is approved
5. The technical person in charge has CDAKB training certificate
6. Business Operations Plan
7. List of Product Types Distributed
8. Product manual
9. Owned HR data
10. Own storage facilities
. Building layout and photos
. List of warehouse equipment
11. Technicians who own or cooperate with distributors or manufacturers who hold a license to distribute electronic medical devices and/or in vitro diagnostic instruments.
Special requirements for medical device distribution branches
1. Technical leaders have CDAKB training certificate
2. Business operation plan
3. List of product types to be distributed
4. Product manuals, HR data owned
5. Own storage facilities
6. Layout and photos of the building
7. Established procedures in accordance with government regulations to support business activities
8. Warehouse Equipment List
9. Technicians owned by themselves or in cooperation with their central distributor for medical and/or electro-medical device
Notice
1. Facilities of medical device distribution and branch offices must have buildings and facilities that meet product requirements, whose office, warehouse, and/or workshop addresses cannot be virtual addresses, and must be compliant.
2. Medical device dealers or branches must have an organizational structure that meets operational needs, equipped with a company structure chart, and clearly explain the responsibilities and authorities of each person. There must be 1 technician who is Indonesian nationality, and has the ability and ability to be accepted. Authorized, responsible, make the distribution system work well, ensure the safety and quality of medical device, have a minimum educational background according to the following table.
Radiation electronic medical device
. DIII/S1: Pharmacist/Pharmacist
. DIII/DIV: Electromedicine
. S1: Electrical Engineering
. DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
. S1: Biomedical Engineering
. S1: Medical Physics
Non-radiating electronic medical device
. DIII/S1: Pharmacist/Pharmacist
. DIII/DIV: Electromedicine
. S1: Electrical Engineering
. DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
. S1: Biomedical Engineering
. DIII/S1 Informatics Engineering (specifically for medical device software)
. DIII refractive optics (especially eye care devices)
. DIII Dental Engineering (specialized for dental equipment)
Sterile Non-Electronic Medical Devices
. DIII/S1: Pharmacist/Pharmacist
General medical device
. PJT Education
3. The technical leader shall not be a director/commissioner, if the company has other production or distribution facilities, there must be a different technical leader.
4. The person in charge of technology must be trained on the Good Circulation of Medical device (CDAKB), and have a CDAKB training certificate to prove it.
5. The technical person in charge needs to be a full-time worker. If the technical person in charge is temporarily unable to perform his duties (such as sick leave, maternity leave, etc.), the dealers and branches must appoint a temporary substitute for the technical person in charge with background.
6. There must be a cooperation agreement between the company and the technical director, which must be certified by a notary public.
7. If a dealer or a dealer’s branch has more than 1 warehouse location, there must be an educated warehouse manager at each location.
8. There must be a training program in place to improve the human resource’s ability to manage medical device.
9. Persons handling medical device are at high risk and/or may cause adverse effects, such as infections and allergies, requiring special training.
10. Must have a competent and experienced technician capable of installing, maintaining and repairing distributed medical devices with a minimum SMK education and full-time working hours in electrical engineering, mechanics or automotive
The application process
1. The applicant must submit a written application to the Department of Health.
URL: http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
2. Within 12 working days after receiving the copy of the application, the person in charge will cooperate with the person in charge of the district/city health office to form a joint inspection team to conduct local inspections.
3. If the requirements are met, the results of the inspection by the Joint Inspection Unit shall be forwarded to the Director General within 6 working days of receipt.
Responsibility
1. The product license holder must be responsible for any product liability for the sale of medical devices, in vitro diagnostic medical devices.
2. Any medical device and in vitro diagnostic medical device produced by OEM are not only responsible for the product license holder, but also the product owner.
3. Any entrusted production of medical device and in vitro diagnostic medical device is not only the responsibility of the product license holder, but also the responsibility of the entrusted manufacturer.
【参考连结】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-35
HLF-ID-40
外国公司销售到印尼医疗器材本身,进口前需要办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?
医疗器材包装内容及各种标示,需要事先核准吗?可允许的语文有哪些?网页?
Do foreign companies need to apply for an approval before importing medical devices sold to Indonesia? If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD:
需要,由印尼当地的公司名义申请医疗器材产品许可证。
在印尼生产、进口、组装和/或重新包装以供经销的任何医疗器材、体外诊断医疗器材必须具有产品许可证,申请人须为当地合法成立的公司实体或商业实体,进口医疗器材、体外诊断医疗器材的产品许可申请人:
1. 独家代理/独家经销商/独家经销商。
2. 经销商(PAK)、进口商(PKRT):拥有製造商或委託人的书面任命,并被授权在印尼註册医疗器材、体外诊断医疗器材。
3. 经销商(PAK)、进口商(PKRT):作为拥有与製造商书面协议的产品所有者。
4. 进行组装、重新包装的经销商(PAK) 。
申请产品许可证需要具备:
1.符合良好的生产规范。
2.经临床评估报告和/或任何其他证据证明的安全性、有效性。
3.剂量不超过现行标准、要求和规定的含量限值。
4.根据现行标准、要求和规定,不使用任何违禁材料。
5. 必须附有原产国卫生当局签发的自由销售证书(CFS),如果未在原产国註册,则 CFS 可由原产国的任何其他机构签发。证明需要显示:
.商品名称/品牌名称
.产品类型
.製造商的名称和地址
.有效期
申请流程
1. 药房和医疗器材总局 (Regalkes) 电子系统网页提交申请资料。
网页:http://regalkes.kemkes.go.id/
2. 申请所需文件
行政要求
.生产证书/PAK 许可证
.作为独家代理/独家经销商/独家经销商的授权书
.相关机构出具的自由销售证明(CFS) (进口产品)
.质量管理体系文件(ISO 13485、ISO 9001、CE等)
. 商标证书(如果有)
技术要求
.产品信息:材料、配方、器材信息、描述和特徵、标准及生产工艺、适应症、预期用途和使用说明、禁忌症、警告、小心、不良的潜在影响。
.规格要求及质量保证:原材料规格和材料安全数据表 (MSDS)
.包装规格
.设备性能规格
.实验室测试结果:分析证书(CoA)、稳定性测试、无菌测试、电力安全测试
.临床前、临床研究结果(针对 C 、 D 类医疗器材和体外诊断医疗器材)
.风险管理
特殊要求
.辐射材料安全
.国家参考实验室对爱滋病毒产品的临床试验
标籤要求
.标籤样例及说明
.使用说明、材料安装和维护说明
上市后要求
.不良事件和投诉的记录和管理程序
3. 申请人须对电子系统上传的任何申请文件的完整性、真实性和有效性负责。专家将对医疗器材产品许可证、体外诊断医疗器材的每项申请进行行政、技术要求的评估、验证,执行期如下:
.A类15天以内。
.B类30天以内。
.C类30天以内。
.D类45天以内。
4. 产品许可证以电子形式签发自行打印,如遇不可抗力,可纸本签发。
5. PKRT 作为非税收国家收入需要由电子支付缴纳费用。
6. 产品许可证有效期最长为5年。
7. 如果产品许可证申请是由指定为独家代理/独家经销商/独家经销商和/或授权註册的 PAK 或 PKRT 公司提交的,则产品许可证的有效期遵循该任命或授权的期限,至少2年、最多5年。
8. 如果医疗器材、体外诊断医疗器材由製造商通过 OEM 生产,其产品许可证的有效期不超过3年。
9. 产品许可证的有效期可以在满足任何要求的情况下进行更新。
包装与标示
医疗器材与体外诊断医疗器材标籤和信息必须说明安全性、有效性/性能、使用说明和/或任何其他信息的条件。所需资料:
1. 商品名称/品牌名称
2. 产品许可证号
3. 产品类型
4. 生产商/製造商的名称和地址
5. PKRT 进口商的名称和地址
6. 批号/生产代码/序列号
7. 无菌一词以及如何对无菌产品进行灭菌(如果适用)
8. 产品规格
9. 使用目的和使用说明
10. 有效期(如果适用)
11. 使用的活性材料清单及其百分比
12. 淨重或淨含量
13. 生产代码
14. 使用/製备说明
15. 小心和警告
16. 某些医疗器材和体外诊断医疗器材的警告标籤,例如仅限专业使用或字母符号P,黑色背景白色字体,必须由合格人员使用。
17.若包含活性物质的淨含量、成分和含量、禁忌症、注意和警告标籤或 KTD/副作用的声明,则标籤和信息必须说明相同的。
18.上述内容必须以印度尼西亚语呈现,若没有对应词或无法创建对应词或用于海外贸易,则允许使用印尼语以外的其他语言。
19.医疗器材、体外诊断医疗器材的标籤和信息禁止使用以下词语:
.最高级的词,例如最、非常、第一、唯一、顶级、有效、超级、卓越、惊人、神奇、完美或带有-est(最)后缀的词,和/或解释这种优越性的相同含义的词。
.诸如无菌、无蚊虫、安全、根除、芳香疗法、抗衰老、治疗、预防登革热、抗病毒、放松、医生推荐和/或任何其他同义词。
.撰写百分比或其他声明以彰显产品的有效性。
.在任何家用农药产品中使用家庭、儿童、婴儿、柔软、保湿和/或任何其他具有相同含义的词语。
清真认证程序
1. 产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。
2.根据申请,指定 LPH 对产品的清真状态进行检查和/或测试。
3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中,如果有成分怀疑清真性,应在实验室进行检测。
4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI,并将副本发送给 BPJPH。
5.产品清真度的确定由 MUI 进行,并在 Halal Fatwa Assembly 中进行。清真产品认定法令(Halal Fatwa)由 MUI 提交给 BPJPH,作为颁发清真证书的依据。
6.如果清真教令大会确定经营者申请的产品为清真产品,BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品,BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。
7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。
清真保证体係以清真政策为基础,建立清真管理团队,编制HAS手册,进行培训,编制相关HAS程序,实施内部审计,正确审查管理。
8. 认证文件
.产品清单
.材料清单和材料文件
.屠夫清单(特别是屠宰场)
.产品矩阵
.HAS 手册
.工艺流程图
.生产设施地址清单
.清真政策传播的证据
.内部培训的证据和内部审计的证据。
9. 註册清真证书(上传数据)
10. 监控清真认证过程的预审核和合同付款
11. 执行审计
12. 执行审计后监控
13. 清真证书有效期为4年
14. 提交清真证书的申请者必须:
.提供正确、清晰和真实的信息
.在清真和非清真产品之间分离加工、储存、包装、经销、销售和展示的位置、场所和设备
.向 BPJPH 报告材料成分的变化
15.获得清真证书的经营者必须:
.在获得清真证书的产品上贴上清真标籤
.保持已获得清真证书的产品的清真
.将清真产品和非清真产品的加工、储存、包装、经销、销售和展示的地点、场所和设备分开
.如果清真证书的有效期已过,须更新清真证书
.向 BPJPH 报告材料成分的变化
16. 清真标籤:经清真认证的产品必须在外包装上标明清真,或未经清真认证的非清真信息。
已获得清真证书的经营者必须在以下位置贴上清真标籤:
.产品包装
.产品的特定部分
.产品的具体位置
.清真标籤必须易于查看和阅读,并且不易擦除、分离和损坏。
Yes, only a local company in Indonesia can register the medical device.
Any medical device, in vitro diagnostic medical device produced, imported, assembled and/or repackaged for distribution in Indonesia must have a product license, and the applicant must be a locally legally established corporate entity or commercial entity importing medical devices, in vitro diagnostic Applicants for product licenses for medical devices:
1. Sole Agent/Exclusive Distributor/Exclusive Distributor.
2. Distributors (PAK), Importers (PKRT): Have the written appointment of the manufacturer or the principal, and are authorized to register medical devices, in vitro diagnostic medical devices in Indonesia.
3. Distributor (PAK), Importer (PKRT): As the product owner who has a written agreement with the manufacturer.
4. Distributors (PAKs) for assembly, repackaging.
To apply for a product license you must have:
1. Comply with Good Manufacturing Practice.
2. Safety and efficacy proven by clinical evaluation report and/or any other evidence.
3. The dosage should not exceed the content limit of the current standards, requirements and regulations.
4. Do not use any prohibited materials according to current standards, requirements and regulations.
5. Must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of origin, if not registered in the country of origin, the CFS can be issued by any other agency in the country of origin. Evidence needs to show:
.Product Name/Brand Name
.Type of product
.Manufacturer’s name and address
.Validity period
The application process
1. Submit application materials on the Electronic System webpage of the General Directorate of Pharmacies and Medical device (Regalkes).
URL: http://regalkes.kemkes.go.id/
2. Required documents for application
Administrative Request
.Production Certificate/PAK License
.Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
.Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
.Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
.Trademark certificate (if any)
Technical requirements
.Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
.Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
.Packaging Specifications
.Equipment Performance Specifications
.Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
.Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
.Risk Management
special requirements
. Radiation Material Safety
. Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
. Label samples and descriptions
. Instructions for use, material installation and maintenance instructions
post-marketing requirements
. Adverse Events and Complaints Recording and Management Procedures
3. The applicant shall be responsible for the completeness, authenticity and validity of any application documents uploaded by the electronic system. Experts will evaluate and verify the administrative and technical requirements of each application for medical device product license and in vitro diagnostic medical device. The implementation period is as follows:
. Class A within 15 days.
. Class B within 30 days.
. Class C within 30 days.
. Class D within 45 days.
4. The product license is issued in electronic form and printed by itself. In case of force majeure, it can be issued in paper.
5. PKRT as non-tax state income needs to be paid electronically.
6. Product licenses are valid for a maximum of 5 years.
7. If a product license application is submitted by a PAK or PKRT company designated as Sole Agent/Exclusive Distributor/Sole Distributor and/or Authorized Registration, the Product License will be valid for the duration of that appointment or authorization for at least 2 years, up to 5 years.
8. If the medical device, in vitro diagnostic medical device is produced by the manufacturer through OEM, the validity period of its product license shall not exceed 3 years.
9. The validity period of the product license can be renewed if any requirements are met.
Packaging and Labeling
Medical device and in vitro diagnostic medical device labels and information must state the conditions for safety, efficacy/performance, instructions for use and/or any other information. required materials:
1. Product name/brand name
2. Product License Number
3. Product Type
4. Manufacturer/manufacturer’s name and address
5. Name and address of PKRT importer
6. Lot Number/Production Code/Serial Number
7. The term sterile and how sterile products are sterilized (if applicable)
8. Product Specifications
9. Purpose of use and instructions for use
10. Validity Period (if applicable)
11. List of active materials used and their percentages
12. Net weight or net content
13. Production code
14. Instructions for use/preparation
15. Cautions and Warnings
16. Warning labels for certain medical devices and in vitro diagnostic medical devices, such as professional use only or the letter symbol P, in white font on a black background, must be used by qualified personnel.
17. If a statement of the net content of the active substance, ingredients and amounts, contraindications, caution and warning labels or KTD/side effects are included, the label and information must state the same.
18. The above content must be presented in Indonesian. Languages other than Indonesian are allowed if there is no corresponding word or it cannot be created or used for overseas trade.
19. The following words are prohibited in the labels and information of medical devices and in vitro diagnostic medical devices:
. Superlative words such as most, very, first, only, top, effective, super, excellent, amazing, amazing, perfect, or words with the -est (most) suffix, and/or the same that explains this superiority meaning of words.
. Such as sterile, mosquito-free, safe, eradication, aromatherapy, anti-aging, therapeutic, dengue prevention, anti-viral, relaxing, doctor recommended and/or any other synonym.
. Write percentages or other claims to demonstrate the effectiveness of the product.
. Use of family, child, baby, softening, moisturizing and/or any other words with the same meaning in any household pesticide product.
Halal certification process
1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.
2. Upon application, designate LPH to inspect and/or test the halal status of the product.
3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.
4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.
5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.
6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.
7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.
8. Certification documents
. Product List
. Bill of Materials and Material Documentation
. Butcher’s List (especially slaughterhouses)
. Product Matrix
. HAS Manual
. Flow chart
. Production Facility Address List
. Evidence of the spread of the halal policy
. Evidence of internal training and evidence of internal audit.
9. Register Halal Certificate (Upload Data)
10. Monitor the pre-audit and contract payments for the halal certification process
11. Perform an audit
12. Perform post-audit monitoring
13. Halal certificate is valid for 4 years
14. Applicants submitting a halal certificate must:
.Provide correct, clear and truthful information
.Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display
.Reporting changes in material composition to BPJPH
15. Operators who have obtained a Halal certificate must:
.Put a halal label on products with a halal certificate
.Maintain halal for products that have obtained a halal certificate
.Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products
.If the validity period of the halal certificate has passed, the halal certificate must be renewed
.Report changes to material composition to BPJPH
16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:
.Product packaging
.Specific part of the product
.The exact location of the product
.Halal labels must be easy to see and read, and not easily erased, detached and damaged.
【参考连结】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-45
HLF-ID-50
外国公司可以用自己名义申请办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?
医疗器材包装内容及各种标示,需要事先核准吗?可允许的语文有哪些?网页?
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 medical devices packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD:
须由印尼当地的公司名义申请医疗器材产品许可证。
在印尼生产、进口、组装和/或重新包装以供经销的任何医疗器材、体外诊断医疗器材必须具有产品许可证,申请人须为当地合法成立的公司实体或商业实体,进口医疗器材、体外诊断医疗器材的产品许可申请人:
1. 独家代理/独家经销商/独家经销商。
2. 经销商(PAK)、进口商(PKRT):拥有製造商或委託人的书面任命,并被授权在印尼註册医疗器材、体外诊断医疗器材。
3. 经销商(PAK)、进口商(PKRT):作为拥有与製造商书面协议的产品所有者。
4. 进行组装、重新包装的经销商(PAK) 。
申请产品许可证需要具备:
1.符合良好的生产规范。
2.经临床评估报告和/或任何其他证据证明的安全性、有效性。
3.剂量不超过现行标准、要求和规定的含量限值。
4.根据现行标准、要求和规定,不使用任何违禁材料。
5. 必须附有原产国卫生当局签发的自由销售证书(CFS),如果未在原产国註册,则 CFS 可由原产国的任何其他机构签发。证明需要显示:
.商品名称/品牌名称
.产品类型
.製造商的名称和地址
.有效期
申请流程
1. 药房和医疗器材总局 (Regalkes) 电子系统网页提交申请资料。
网页:http://regalkes.kemkes.go.id/
2. 申请所需文件
行政要求
.生产证书/PAK 许可证
.作为独家代理/独家经销商/独家经销商的授权书
.相关机构出具的自由销售证明(CFS) (进口产品)
.质量管理体系文件(ISO 13485、ISO 9001、CE等)
.商标证书(如果有)
技术要求
.产品信息:材料、配方、器材信息、描述和特徵、标准及生产工艺、适应症、预期用途和使用说明、禁忌症、警告、小心、不良的潜在影响。
.规格要求及质量保证:原材料规格和材料安全数据表 (MSDS)
.包装规格
.设备性能规格
.实验室测试结果:分析证书(CoA)、稳定性测试、无菌测试、电力安全测试
.临床前、临床研究结果(针对 C 、 D 类医疗器材和体外诊断医疗器材)
.风险管理
特殊要求
.辐射材料安全
.国家参考实验室对爱滋病毒产品的临床试验
标籤要求
.标籤样例及说明
.使用说明、材料安装和维护说明
上市后要求
.不良事件和投诉的记录和管理程序
3. 申请人须对电子系统上传的任何申请文件的完整性、真实性和有效性负责。
专家将对医疗器材产品许可证、体外诊断医疗器材的每项申请进行行政、技术要求的评估、验证,执行期如下:
.A类15天以内。
.B类30天以内。
.C类30天以内。
.D类45天以内。
4. 产品许可证以电子形式签发自行打印,如遇不可抗力,可纸本签发。
5. PKRT 作为非税收国家收入需要由电子支付缴纳费用。
6. 产品许可证有效期最长为5年。
7. 如果产品许可证申请是由指定为独家代理/独家经销商/独家经销商和/或授权註册的 PAK 或 PKRT 公司提交的,则产品许可证的有效期遵循该任命或授权的期限,至少2年、最多5年。
8. 如果医疗器材、体外诊断医疗器材由製造商通过 OEM 生产,其产品许可证的有效期不超过3年。
9. 产品许可证的有效期可以在满足任何要求的情况下进行更新。
包装与标示
医疗器材与体外诊断医疗器材标籤和信息必须说明安全性、有效性/性能、使用说明和/或任何其他信息的条件。所需资料:
1. 商品名称/品牌名称
2. 产品许可证号
3. 产品类型
4. 生产商/製造商的名称和地址
5. PKRT 进口商的名称和地址
6. 批号/生产代码/序列号
7. 无菌一词以及如何对无菌产品进行灭菌(如果适用)
8. 产品规格
9. 使用目的和使用说明
10. 有效期(如果适用)
11. 使用的活性材料清单及其百分比
12. 淨重或淨含量
13. 生产代码
14. 使用/製备说明
15. 小心和警告
16. 某些医疗器材和体外诊断医疗器材的警告标籤,例如仅限专业使用或字母符号P,黑色背景白色字体,必须由合格人员使用。
17.若包含活性物质的淨含量、成分和含量、禁忌症、注意和警告标籤或 KTD/副作用的声明,则标籤和信息必须说明相同的。
18.上述内容必须以印度尼西亚语呈现,若没有对应词或无法创建对应词或用于海外贸易,则允许使用印尼语以外的其他语言。
19.医疗器材、体外诊断医疗器材的标籤和信息禁止使用以下词语:
.最高级的词,例如最、非常、第一、唯一、顶级、有效、超级、卓越、惊人、神奇、完美或带有-est(最)后缀的词,和/或解释这种优越性的相同含义的词。
.诸如无菌、无蚊虫、安全、根除、芳香疗法、抗衰老、治疗、预防登革热、抗病毒、放松、医生推荐和/或任何其他同义词。
.撰写百分比或其他声明以彰显产品的有效性。
.在任何家用农药产品中使用家庭、儿童、婴儿、柔软、保湿和/或任何其他具有相同含义的词语。
清真认证程序
1. 产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。
2.根据申请,指定 LPH 对产品的清真状态进行检查和/或测试。
3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中,如果有成分怀疑清真性,应在实验室进行检测。
4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI,并将副本发送给 BPJPH。
5.产品清真度的确定由 MUI 进行,并在 Halal Fatwa Assembly 中进行。清真产品认定法令(Halal Fatwa)由 MUI 提交给 BPJPH,作为颁发清真证书的依据。
6.如果清真教令大会确定经营者申请的产品为清真产品,BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品,BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。
7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。清真保证体係以清真政策为基础,建立清真管理团队,编制HAS手册,进行培训,编制相关HAS程序,实施内部审计,正确审查管理。
8. 认证文件
.产品清单
.材料清单和材料文件
.屠夫清单(特别是屠宰场)
.产品矩阵
.HAS 手册
.工艺流程图
.生产设施地址清单
.清真政策传播的证据
.内部培训的证据和内部审计的证据。
9. 註册清真证书(上传数据)
10. 监控清真认证过程的预审核和合同付款
11. 执行审计
12. 执行审计后监控
13. 清真证书有效期为4年
14. 提交清真证书的申请者必须:
.提供正确、清晰和真实的信息
.在清真和非清真产品之间分离加工、储存、包装、经销、销售和展示的位置、场所和设备
.向 BPJPH 报告材料成分的变化
15.获得清真证书的经营者必须:
.在获得清真证书的产品上贴上清真标籤
.保持已获得清真证书的产品的清真
.将清真产品和非清真产品的加工、储存、包装、经销、销售和展示的地点、场所和设备分开
.如果清真证书的有效期已过,须更新清真证书
.向 BPJPH 报告材料成分的变化
16. 清真标籤:经清真认证的产品必须在外包装上标明清真,或未经清真认证的非清真信息。已获得清真证书的经营者必须在以下位置贴上清真标籤:
.产品包装
.产品的特定部分
.产品的具体位置
.清真标籤必须易于查看和阅读,并且不易擦除、分离和损坏。
Only a local company in Indonesia can register the medical device.
Any medical device, in vitro diagnostic medical device produced, imported, assembled and/or repackaged for distribution in Indonesia must have a product license, and the applicant must be a locally legally established corporate entity or commercial entity importing medical devices, in vitro diagnostic Applicants for product licenses for medical devices:
1. Sole Agent/Exclusive Distributor/Exclusive Distributor.
2. Distributors (PAK), Importers (PKRT): Have the written appointment of the manufacturer or the principal, and are authorized to register medical devices, in vitro diagnostic medical devices in Indonesia.
3. Distributor (PAK), Importer (PKRT): As the product owner who has a written agreement with the manufacturer.
4. Distributors (PAKs) for assembly, repackaging.
To apply for a product license you must have:
1. Comply with Good Manufacturing Practice.
2. Safety and efficacy proven by clinical evaluation report and/or any other evidence.
3. The dosage should not exceed the content limit of the current standards, requirements and regulations.
4. Do not use any prohibited materials according to current standards, requirements and regulations.
5. Must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of origin, if not registered in the country of origin, the CFS can be issued by any other agency in the country of origin. Evidence needs to show:
.Product Name/Brand Name
.Type of product
.Manufacturer’s name and address
.Validity period
The application process
1. Submit application materials on the Electronic System webpage of the General Directorate of Pharmacies and Medical device (Regalkes).
URL: http://regalkes.kemkes.go.id/
2. Required documents for application
Administrative Request
.Production Certificate/PAK License
.Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
.Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
.Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
.Trademark certificate (if any)
Technical requirements
.Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
.Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
.Packaging Specifications
.Equipment Performance Specifications
.Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
.Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
.Risk Management
special requirements
. Radiation Material Safety
. Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
. Label samples and descriptions
. Instructions for use, material installation and maintenance instructions
post-marketing requirements
. Adverse Events and Complaints Recording and Management Procedures
3. The applicant shall be responsible for the completeness, authenticity and validity of any application documents uploaded by the electronic system. Experts will evaluate and verify the administrative and technical requirements of each application for medical device product license and in vitro diagnostic medical device. The implementation period is as follows:
. Class A within 15 days.
. Class B within 30 days.
. Class C within 30 days.
. Class D within 45 days.
4. The product license is issued in electronic form and printed by itself. In case of force majeure, it can be issued in paper.
5. PKRT as non-tax state income needs to be paid electronically.
6. Product licenses are valid for a maximum of 5 years.
7. If a product license application is submitted by a PAK or PKRT company designated as Sole Agent/Exclusive Distributor/Sole Distributor and/or Authorized Registration, the Product License will be valid for the duration of that appointment or authorization for at least 2 years, up to 5 years.
8. If the medical device, in vitro diagnostic medical device is produced by the manufacturer through OEM, the validity period of its product license shall not exceed 3 years.
9. The validity period of the product license can be renewed if any requirements are met.
Packaging and Labeling
Medical device and in vitro diagnostic medical device labels and information must state the conditions for safety, efficacy/performance, instructions for use and/or any other information. required materials:
1. Product name/brand name
2. Product License Number
3. Product Type
4. Manufacturer/manufacturer’s name and address
5. Name and address of PKRT importer
6. Lot Number/Production Code/Serial Number
7. The term sterile and how sterile products are sterilized (if applicable)
8. Product Specifications
9. Purpose of use and instructions for use
10. Validity Period (if applicable)
11. List of active materials used and their percentages
12. Net weight or net content
13. Production code
14. Instructions for use/preparation
15. Cautions and Warnings
16. Warning labels for certain medical devices and in vitro diagnostic medical devices, such as professional use only or the letter symbol P, in white font on a black background, must be used by qualified personnel.
17. If a statement of the net content of the active substance, ingredients and amounts, contraindications, caution and warning labels or KTD/side effects are included, the label and information must state the same.
18. The above content must be presented in Indonesian. Languages other than Indonesian are allowed if there is no corresponding word or it cannot be created or used for overseas trade.
19. The following words are prohibited in the labels and information of medical devices and in vitro diagnostic medical devices:
. Superlative words such as most, very, first, only, top, effective, super, excellent, amazing, amazing, perfect, or words with the -est (most) suffix, and/or the same that explains this superiority meaning of words.
. Such as sterile, mosquito-free, safe, eradication, aromatherapy, anti-aging, therapeutic, dengue prevention, anti-viral, relaxing, doctor recommended and/or any other synonym.
. Write percentages or other claims to demonstrate the effectiveness of the product.
. Use of family, child, baby, softening, moisturizing and/or any other words with the same meaning in any household pesticide product.
Halal certification process
1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.
2. Upon application, designate LPH to inspect and/or test the halal status of the product.
3. LPH appoints halal auditors to conduct halal inspections of products.
Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.
4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.
5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.
6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.
7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.
8. Certification documents
. Product List
. Bill of Materials and Material Documentation
. Butcher’s List (especially slaughterhouses)
. Product Matrix
. HAS Manual
. Flow chart
. Production Facility Address List
. Evidence of the spread of the halal policy
. Evidence of internal training and evidence of internal audit.
9. Register Halal Certificate (Upload Data)
10. Monitor the pre-audit and contract payments for the halal certification process
11. Perform an audit
12. Perform post-audit monitoring
13. Halal certificate is valid for 4 years
14. Applicants submitting a halal certificate must:
.Provide correct, clear and truthful information
.Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display
.Reporting changes in material composition to BPJPH
15. Operators who have obtained a Halal certificate must:
.Put a halal label on products with a halal certificate
.Maintain halal for products that have obtained a halal certificate
.Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products
.If the validity period of the halal certificate has passed, the halal certificate must be renewed
.Report changes to material composition to BPJPH
16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:
.Product packaging
.Specific part of the product
.The exact location of the product
.Halal labels must be easy to see and read, and not easily erased, detached and damaged.
【参考连结】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-55
HLF-ID-60
经过核准登记的医疗器材,进口到印尼要检附什麽文件?经过什麽手续?
在销售时要向各地的卫生福利部相关机构事先或事后准备吗?网页?
What documents are required when importing approved medical devices into Indonesia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD:
海关流程
1. 至海关总局註册并取得海关註册编号(NIK)
网页:https://customer.beacukai.go.id/index.html?page=registrasi
2. 取得进口许可证,有效期为5年,其后可以续期。
3. 进口许可证可透过电子资料联通(EDI)管理,并分为两类:
.一般进口商註册编号(API-U):适用于普通贸易
.生产型进口商註册编号(API-P) :适用于进口自用商品的进口商,例如原材料、辅助材料及/或其他用作支援生产过程的产品
4. 填妥进口申报表并向海关总局提交,包含:
.进口申报表
.发票
.包装清单
.提单
.保险保单
.进口关税
.相关税项收据等。
5. 在取得进出口商代码和进口许可证后,进口商应确定并申报进口物品的来源或产地,并遵从清关手续。
6. 计算进口关税率(输入任何进口货物的进口商,应自行评估对此类货物徵收的关税)
7. 须提供资料
.姓名、完整的营业地址
.保存或储存通知货物的场所的情况和描述
.货物的详情
.日期以及收到此类货物的人的姓名和完整地址
.货物所有人的姓名
.货物的名称
.取出货物场所的位置
.通知货物被运往场所的位置
.运输工具(如果使用机动车辆运输通知货物,需填写机动车辆的登记号。)
.运输路线、开始运输的时间日期、可能到达目的地的时间和日期
.销售或转让通知货物的人的姓名和完整的营业地址
.向其出售或转让通知货物的人的姓名和完整地址
.出售或转让的时间和日期
.货物的数量、市场价格
.序列号(如果有)
.批号(如果有)
.专利号(如果有)
.製造商、原产国(如果有)
.品牌(如果有)
.商标(如果有)
8.货物在获准入境前不得从船上卸货
9.仅在批准的地点卸货和装货
10.进口商在出示入境单时应就该入境单的内容的真实性作出并签署声明,并应为支持该声明,向有关官员出示发票(如有)以及可能规定的与进口货物有关的其他文件
11. 入境单的进口商应确保以下事项
.提供信息的准确性和完整性
.任何支持它的文件的真实性和有效性
.遵守本法或当时有效的任何其他法律对货物的限制或禁止
Customs procedures
1. Register at the General Administration of Customs and obtain a Customs Registration Number (NIK)
URL: https://customer.beacukai.go.id/index.html?page=registrasi
2. Obtain the import license, which is valid for 5 years, and can be renewed thereafter.
3. Import licenses can be managed through Electronic Data Interconnection (EDI) and are classified into two categories:
. General Importer Registration Number (API-U): for general trade
. Production Importer Registration Number (API-P): For importers of goods for their own use, such as raw materials, auxiliary materials and/or other products used to support the production process
4. Complete the import declaration form and submit it to the General Administration of Customs, which includes:
. Invoice
. Packaging List
. B/L
. Insurance policy
. Import duty
. Relevant tax receipts, etc.
5. After obtaining the importer and exporter code and import license, the importer should determine and declare the source or origin of the imported goods and follow the customs clearance procedures.
6. Calculation of import duty rates (importers who import any imported goods should assess their own duties on such goods)
7. Information required
.Name, full business address
.Conditions and description of the premises where the notified goods are kept or stored
.Details of the goods
.The date and the name and full address of the person who received such shipment
.The name of the owner of the goods
.The name of the goods
.The location of the place where the goods are taken out
.Notify the location of the goods being shipped to the premises
.Means of transportation (If a motor vehicle is used to transport the notified goods, the registration number of the motor vehicle is required.)
.Shipping route, time and date of start of shipment, possible time and date of arrival at destination
.The name and full business address of the person who sold or transferred the notified goods
.Name and full address of the person to whom the notified goods are sold or transferred
.Time and date of sale or assignment
.Quantity of goods, market price
.Serial number (if available)
.Lot number (if available)
.Patent number (if applicable)
.Manufacturer, country of origin (if applicable)
.Brand (if available)
.Trademark (if applicable)
8. The cargo shall not be unloaded from the vessel before it is allowed to enter the country
9. Only unload and load goods at approved locations
10. The importer shall make and sign a declaration on the authenticity of the contents of the entry document when presenting the entry document, and shall, in support of the declaration, present to the relevant officials the invoice (if any) and other provisions related to the imported goods as may be stipulated. document
11. The importer of the entry note shall ensure the following
.Accuracy and completeness of information provided
.The authenticity and validity of any documents that support it
.Comply with any restrictions or prohibitions on the Goods under this Act or any other law then in force
【参考连结】
https://www.beacukai.go.id/index.html
HLF-ID-70
印尼医疗器材审核机构,需要附上的实验室检验资料有哪些? 网页?
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD:
在印尼,医疗器材欲取得产品许可,製造商需符合GMP,并且需有质量管理体系文件(ISO 13485、ISO 9001、CE等)证明,需缴交相关资料:
行政要求
.生产证书/PAK 许可证
.作为独家代理/独家经销商/独家经销商的授权书
.相关机构出具的自由销售证明(CFS) (进口产品)
.质量管理体系文件(ISO 13485、ISO 9001、CE等)
.商标证书(如果有)
技术要求
.产品信息:材料、配方、器材信息、描述和特徵、标准及生产工艺、适应症、预期用途和使用说明、禁忌症、警告、小心、不良的潜在影响。
.规格要求及质量保证:原材料规格和材料安全数据表 (MSDS)
.包装规格
.设备性能规格
.实验室测试结果:分析证书(CoA)、稳定性测试、无菌测试、电力安全测试
.临床前、临床研究结果(针对 C 、 D 类医疗器材和体外诊断医疗器材)
.风险管理
特殊要求
.辐射材料安全
.国家参考实验室对爱滋病毒产品的临床试验
标籤要求
.标籤样例及说明
.使用说明、材料安装和维护说明
上市后要求
.不良事件和投诉的记录和管理程序
In Indonesia, in order to obtain product licenses for medical devices, manufacturers must comply with GMP, and must have quality management system documents (ISO 13485, ISO 9001, CE, etc.) to prove that they must submit relevant documents:
Administrative Request
.Production Certificate/PAK License
.Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
.Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
.Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
.Trademark certificate (if any)
Technical requirements
.Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
.Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
.Packaging Specifications
.Equipment Performance Specifications
.Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
.Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
.Risk Management
Special requirements
. Radiation Material Safety
. Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
. Label samples and descriptions
. Instructions for use, material installation and maintenance instructions
post-marketing requirements
. Adverse Events and Complaints Recording and Management Procedures
【参考连结】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-75
HLF-ID-77
HLF-ID-80
外国子公司进口医疗器材后,如果委託印尼的经销商销售,经销商需要医疗器材营业许可证吗?
假如医疗器材有品质瑕疵的话,外国子公司和经销商各自的责任为何?是连带责任吗?还是可以规范由外国子公司负责?
After a foreign subsidiary imports medical devices and entrusts a distributor in Indonesia to sell it, does the distributor need a medical devices 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:
须以印尼当地公司名义申请医疗器材经销许可证(DAK)。
责任:
1. 产品许可证持有人必须负责任何医疗器材、体外诊断医疗器材销售的产品责任。
2. 任何通过 OEM 生产的医疗器材、体外诊断医疗器除了产品许可证持有人负有责任,产品所有者也有责任。
3. 任何委託生产的医疗器材、体外诊断医疗器材除了产品许可证持有人负有责任,受委託的製造商也有责任。
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
Responsibility
1. The product license holder must be responsible for any product liability for the sale of medical devices, in vitro diagnostic medical devices.
2. Any medical device and in vitro diagnostic medical device produced by OEM are not only responsible for the product license holder, but also the product owner.
3. Any entrusted production of medical device and in vitro diagnostic medical device is not only the responsibility of the product license holder, but also the responsibility of the entrusted manufacturer.
【参考连结】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-85
联繫我们
Email:jkt4ww@evershinecpa.com
或
印尼永辉BPO有限公司
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