印尼醫療器材登記法規問題集
Email：jkt4ww@evershinecpa.com
或
印尼永輝BPO有限公司
Jakarta time zone:
The Engaging Manager Cindy Luo, Indonesia citizenship, speaks English, Bahasa and Chinese
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
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Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
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linkedin address:Dale Chen Linkedin
HLF-ID-10
請問印尼對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
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，醫療器材由衛生部(MoH) 監管，負責上市前和上市後評估、標準化、立法和良好生產規範 (GMP) 認證。
在進口之前，醫療器材和 體外診斷醫療器材(IVD) 必須獲得衛生部頒發給當地特許經銷商的註冊號和產品許可證。
1. 醫療器材：用於預防、診斷、治癒和緩解疾病、治療病人、恢復人類健康和/或形成結構、改善身體功能的儀器、設備、機器和/或植入物，但不包含藥物。醫療器材可以單獨或組合用於人類，具有以下一種或多種用途：
．診斷、預防、監測、治療或減少疾病。
．疾病狀況的診斷、監測、治療、減輕或補償。
．調查、替換、修改、解剖支持或生理過程。
．支持或維持生命。
．阻礙受精。
．醫療器材消毒劑。
．通過對標本和人體進行體外測試，為醫療或診斷目的提供信息。
2. 體外診斷醫療器材：試劑、校準物、對照材料、試劑盒、儀器、裝置或系統，單獨或結合使用在檢查任何體外標本(包括人類來源的血液或組織)的設備或系統，目的主要是為了提供以下一種或多種訊息：
．生理或病理狀況或先天性異常。
．確定血液或組織捐獻者與潛在接受者的安全性和適用性。
．監測治療的狀態。
3. 治療性有源醫療器材：有源醫療器材，單獨或與其他醫療器材組合使用，支持、修改、替換或改善生物功能或結構，治療或減少疾病、傷害或殘疾。
4. 診斷有源醫療器材：有源醫療器材，單獨或與其他醫療器材結合使用，檢測、診斷、監測或幫助治療生理狀況、健康水平、疾病或先天性殘疾。
5. 活動醫療器材：使用有源醫療器材以外的能源運行的醫療器材。
6. 侵入性醫療器材：通過身體開口/表面全部/部分進入身體的醫療器材。
7. 無創醫療器材：不會通過身體開口/身體表面全部/部分穿透身體的醫療器材。
醫療器材分類：醫療器材是根據使用這些醫療器材過程中產生的風險進行分類的，基於這些風險，醫療器材分為以下四類
1. A類：低風險，例如：手術器材、手術手套、氧氣面罩等。
2. B類：低到中等風險，例如：壓脈帶、蒸汽消毒器等。
3. C類：中到高風險，例如：身高監測器、X光機等。
4. D類：高風險，例如：高風險心臟支架、心臟起搏器等。
體外診斷醫療器材分類：風險等級分類受個體風險因素和公共衛生風險的影響，分為以下四類
1. A類：低個人風險和低公共衛生風險，例如：臨床化學分析儀、膽固醇測試、尿酸測試等。
2. B類：中等個人風險和低公共衛生風險，例如：驗孕棒等。
3. C類：高個人風險和中等公共衛生風險，例如：自用血糖檢測試劑盒、HLA分型測定、PSA篩查等。
4. D類： 高個人風險和高公共衛生風險，例如：捐血者 HIV 篩查、HIV 血液診斷等。
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.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Klasifikasi.pdf
HLF-ID-20
外國公司要到印尼銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
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，須以印尼當地公司名義取得醫療器材經銷許可證(DAK)。
醫療器材經銷商許可證由衛生部頒發，醫療器材的經銷/交付可以從醫療器材經銷商所在的位置在整個印度尼西亞進行。
醫療器材經銷商和分支機構經銷商可以根據所擁有的設施和人力資源，按照批准的產品組來經銷醫療器材，產品分為5組：
1. 輻射電子醫療器材
2. 非輻射電子醫療器材
3. 無菌非電子醫療器材
4. 非無菌電子醫療器材
5. 體外診斷醫療器材
醫療器材經銷商必須滿足以下要求：
1.商業行為者是有限責任公司或合作社形式的非個體商業行為者
2.非稅收國家收入的支付證明（PNBP）
3.技術人員資料
4.業務參與者執行標準的持續時間為 OSS 申請獲得批准後的 1年
5.技術負責人有CDAKB培訓證書
6.業務運營計劃
7.經銷產品類型清單
8.產品說明書
9.擁有的人力資源數據
10.自有存儲設施
．建築物的佈局和照片
．倉庫設備清單
11.自有或與持有經銷電子醫療器材和/或體外診斷儀器經銷許可證的經銷商或製造商合作的技術人員。
醫療器材經銷分公司特殊要求
1. 技術負責人有CDAKB培訓證書
2. 業務運營計劃
3. 經銷產品類型清單
4. 產品手冊、擁有的人力資源數據
5. 自有存儲設施
6. 建築物的佈局和照片
7. 根據政府規定為支持經營活動而製定的固定程序
8. 倉庫設備清單
9. 技術人員由他們自己擁有或與其中央經銷商合作，用於醫療和/或電子醫療設備
注意
1.醫療器材經銷和分支機構的設施必須具有符合產品要求的建築物和設施，其辦公室、倉庫和/或車間地址不能是虛擬地址，並且必須符合標準。
2. 醫療器材經銷商或分公司必須具有符合運營需要的組織結構，配備公司結構圖，並明確說明每個人員的職責和權限，必須有 1名技術人員為印度尼西亞國籍，並符合有能力、被授權、有責任，使配送系統運行良好，確保醫療器材的安全、質量，根據下表具有最低教育背景。
輻射電子醫療設備
．DIII/S1：藥劑師/藥劑師
．DIII/DIV ：電子醫學
．S1：電氣工程
．DIII/DIV 工程：放射診斷和放射治療
．S1：生物醫學工程
．S1：醫學物理
非輻射電子醫療設備
．DIII/S1：藥劑師/藥劑師
．DIII/DIV ：電子醫學
．S1：電氣工程
．DIII/DIV 工程：放射診斷和放射治療
．S1：生物醫學工程
．DIII/S1信息學工程（專門用於醫療設備軟件）
．DIII 折射光學（尤其是眼保健設備）
．DIII 牙科工程（專門用於牙科設備）
無菌非電子醫療器材
．DIII/S1：藥劑師/藥劑師
一般醫療器材
．PJT教育
3. 技術負責人不得兼任董事/委員，如果公司擁有其他生產或經銷設施，則必須有不同的技術負責人。
4. 技術負責人必須接受良好醫療器材流通方式（CDAKB）的培訓，並有CDAKB培訓證書證明。
5. 技術負責人需要為全職工作者，如果技術負責人暫時不能履行職責（如病假、產假等） 經銷商和分支機構必須指定臨時替代人有背景的技術負責人。
6. 必須有公司與技術負責人的合作協議，並經公證人認證。
7. 如果經銷商或經銷商的分支機構擁有超過 1個倉庫位置，則必須在每個位置都有一名具有教育背景的倉庫負責人。
8. 必須有一個培訓計劃，以提高人力資源管理醫療器材的能力。
9. 處理醫療設備的人員處於高風險和/或可能導致不良影響，例如感染和過敏，需要特殊培訓。
10. 必須擁有能夠安裝、維護和維修分佈式醫療器材的稱職且經驗豐富的技術人員，並在電氣工程、機械或汽車領域具有最低限度的 SMK 教育並全職工作時間
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
【參考連結】
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
外國公司要到印尼銷售醫療器材，可以指派印尼公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
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，須以印尼當地公司名義取得醫療器材經銷許可證(DAK)。
醫療器材經銷商許可證由衛生部頒發，醫療器材的經銷/交付可以從醫療器材經銷商所在的位置在整個印度尼西亞進行。醫療器材經銷商和分支機構經銷商可以根據所擁有的設施和人力資源，按照批准的產品組來經銷醫療器材，產品分為5組：
1. 輻射電子醫療器材
2. 非輻射電子醫療器材
3. 無菌非電子醫療器材
4. 非無菌電子醫療器材
5. 體外診斷醫療器材
醫療器材經銷商必須滿足以下要求：
1.商業行為者是有限責任公司或合作社形式的非個體商業行為者
2.非稅收國家收入的支付證明（PNBP）
3.技術人員資料
4.業務參與者執行標準的持續時間為 OSS 申請獲得批准後的 1年
5.技術負責人有CDAKB培訓證書
6.業務運營計劃
7.經銷產品類型清單
8.產品說明書
9.擁有的人力資源數據
10.自有存儲設施
．建築物的佈局和照片
．倉庫設備清單
11.自有或與持有經銷電子醫療器材和/或體外診斷儀器經銷許可證的經銷商或製造商合作的技術人員。
醫療器材經銷分公司特殊要求
1. 技術負責人有CDAKB培訓證書
2. 業務運營計劃
3. 經銷產品類型清單
4. 產品手冊、擁有的人力資源數據
5. 自有存儲設施
6. 建築物的佈局和照片
7. 根據政府規定為支持經營活動而製定的固定程序
8. 倉庫設備清單
9. 技術人員由他們自己擁有或與其中央經銷商合作，用於醫療和/或電子醫療設備
注意
1.醫療器材經銷和分支機構的設施必須具有符合產品要求的建築物和設施，其辦公室、倉庫和/或車間地址不能是虛擬地址，並且必須符合標準。
2. 醫療器材經銷商或分公司必須具有符合運營需要的組織結構，配備公司結構圖，並明確說明每個人員的職責和權限，必須有 1名技術人員為印度尼西亞國籍，並符合有能力、被授權、有責任，使配送系統運行良好，確保醫療器材的安全、質量，根據下表具有最低教育背景。
輻射電子醫療設備
．DIII/S1：藥劑師/藥劑師
．DIII/DIV ：電子醫學
．S1：電氣工程
．DIII/DIV 工程：放射診斷和放射治療
．S1：生物醫學工程
．S1：醫學物理
非輻射電子醫療設備
．DIII/S1：藥劑師/藥劑師
．DIII/DIV ：電子醫學
．S1：電氣工程
．DIII/DIV 工程：放射診斷和放射治療
．S1：生物醫學工程
．DIII/S1信息學工程（專門用於醫療設備軟件）
．DIII 折射光學（尤其是眼保健設備）
．DIII 牙科工程（專門用於牙科設備）
無菌非電子醫療器材
．DIII/S1：藥劑師/藥劑師
一般醫療器材
．PJT教育
3. 技術負責人不得兼任董事/委員，如果公司擁有其他生產或經銷設施，則必須有不同的技術負責人。
4. 技術負責人必須接受良好醫療器材流通方式（CDAKB）的培訓，並有CDAKB培訓證書證明。
5. 技術負責人需要為全職工作者，如果技術負責人暫時不能履行職責（如病假、產假等） 經銷商和分支機構必須指定臨時替代人有背景的技術負責人。
6. 必須有公司與技術負責人的合作協議，並經公證人認證。
7. 如果經銷商或經銷商的分支機構擁有超過 1個倉庫位置，則必須在每個位置都有一名具有教育背景的倉庫負責人。
8. 必須有一個培訓計劃，以提高人力資源管理醫療器材的能力。
9. 處理醫療設備的人員處於高風險和/或可能導致不良影響，例如感染和過敏，需要特殊培訓。
10. 必須擁有能夠安裝、維護和維修分佈式醫療器材的稱職且經驗豐富的技術人員，並在電氣工程、機械或汽車領域具有最低限度的 SMK 教育並全職工作時間
責任
1. 產品許可證持有人必須負責任何醫療器材、體外診斷醫療器材銷售的產品責任。
2. 任何通過 OEM 生產的醫療器材、體外診斷醫療器除了產品許可證持有人負有責任，產品所有者也有責任。
3. 任何委託生產的醫療器材、體外診斷醫療器材除了產品許可證持有人負有責任，受委託的製造商也有責任。
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.
【參考連結】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-35
HLF-ID-40
外國公司銷售到印尼醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
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，由印尼當地的公司名義申請醫療器材產品許可證。
在印尼生產、進口、組裝和/或重新包裝以供經銷的任何醫療器材、體外診斷醫療器材必須具有產品許可證，申請人須為當地合法成立的公司實體或商業實體，進口醫療器材、體外診斷醫療器材的產品許可申請人：
1. 獨家代理/獨家經銷商/獨家經銷商。
2. 經銷商(PAK)、進口商(PKRT)：擁有製造商或委託人的書面任命，並被授權在印尼註冊醫療器材、體外診斷醫療器材。
3. 經銷商(PAK)、進口商(PKRT)：作為擁有與製造商書面協議的產品所有者。
4. 進行組裝、重新包裝的經銷商(PAK) 。
申請產品許可證需要具備：
1.符合良好的生產規範。
2.經臨床評估報告和/或任何其他證據證明的安全性、有效性。
3.劑量不超過現行標準、要求和規定的含量限值。
4.根據現行標準、要求和規定，不使用任何違禁材料。
5. 必須附有原產國衛生當局簽發的自由銷售證書(CFS)，如果未在原產國註冊，則 CFS 可由原產國的任何其他機構簽發。證明需要顯示：
．商品名稱/品牌名稱
．產品類型
．製造商的名稱和地址
．有效期
申請流程
1. 藥房和醫療器材總局 (Regalkes) 電子系統網頁提交申請資料。
網頁：http://regalkes.kemkes.go.id/
2. 申請所需文件
行政要求
．生產證書/PAK 許可證
．作為獨家代理/獨家經銷商/獨家經銷商的授權書
．相關機構出具的自由銷售證明(CFS) (進口產品)
．質量管理體系文件(ISO 13485、ISO 9001、CE等)
． 商標證書(如果有)
技術要求
．產品信息：材料、配方、器材信息、描述和特徵、標準及生產工藝、適應症、預期用途和使用說明、禁忌症、警告、小心、不良的潛在影響。
．規格要求及質量保證：原材料規格和材料安全數據表 (MSDS)
．包裝規格
．設備性能規格
．實驗室測試結果：分析證書(CoA)、穩定性測試、無菌測試、電力安全測試
．臨床前、臨床研究結果(針對 C 、 D 類醫療器材和體外診斷醫療器材)
．風險管理
特殊要求
．輻射材料安全
．國家參考實驗室對愛滋病毒產品的臨床試驗
標籤要求
．標籤樣例及說明
．使用說明、材料安裝和維護說明
上市後要求
．不良事件和投訴的記錄和管理程序
3. 申請人須對電子系統上傳的任何申請文件的完整性、真實性和有效性負責。專家將對醫療器材產品許可證、體外診斷醫療器材的每項申請進行行政、技術要求的評估、驗證，執行期如下：
．A類15天以內。
．B類30天以內。
．C類30天以內。
．D類45天以內。
4. 產品許可證以電子形式簽發自行打印，如遇不可抗力，可紙本簽發。
5. PKRT 作為非稅收國家收入需要由電子支付繳納費用。
6. 產品許可證有效期最長為5年。
7. 如果產品許可證申請是由指定為獨家代理/獨家經銷商/獨家經銷商和/或授權註冊的 PAK 或 PKRT 公司提交的，則產品許可證的有效期遵循該任命或授權的期限，至少2年、最多5年。
8. 如果醫療器材、體外診斷醫療器材由製造商通過 OEM 生產，其產品許可證的有效期不超過3年。
9. 產品許可證的有效期可以在滿足任何要求的情況下進行更新。
包裝與標示
醫療器材與體外診斷醫療器材標籤和信息必須說明安全性、有效性/性能、使用說明和/或任何其他信息的條件。所需資料：
1. 商品名稱/品牌名稱
2. 產品許可證號
3. 產品類型
4. 生產商/製造商的名稱和地址
5. PKRT 進口商的名稱和地址
6. 批號/生產代碼/序列號
7. 無菌一詞以及如何對無菌產品進行滅菌(如果適用)
8. 產品規格
9. 使用目的和使用說明
10. 有效期(如果適用)
11. 使用的活性材料清單及其百分比
12. 淨重或淨含量
13. 生產代碼
14. 使用/製備說明
15. 小心和警告
16. 某些醫療器材和體外診斷醫療器材的警告標籤，例如僅限專業使用或字母符號P，黑色背景白色字體，必須由合格人員使用。
17.若包含活性物質的淨含量、成分和含量、禁忌症、注意和警告標籤或 KTD/副作用的聲明，則標籤和信息必須說明相同的。
18.上述內容必須以印度尼西亞語呈現，若沒有對應詞或無法創建對應詞或用於海外貿易，則允許使用印尼語以外的其他語言。
19.醫療器材、體外診斷醫療器材的標籤和信息禁止使用以下詞語：
．最高級的詞，例如最、非常、第一、唯一、頂級、有效、超級、卓越、驚人、神奇、完美或帶有-est（最）後綴的詞，和/或解釋這種優越性的相同含義的詞。
．諸如無菌、無蚊蟲、安全、根除、芳香療法、抗衰老、治療、預防登革熱、抗病毒、放鬆、醫生推薦和/或任何其他同義詞。
．撰寫百分比或其他聲明以彰顯產品的有效性。
．在任何家用農藥產品中使用家庭、兒童、嬰兒、柔軟、保濕和/或任何其他具有相同含義的詞語。
清真認證程序
1. 產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。
2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。
3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。
4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。
5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。
6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。
7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。
清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。
8. 認證文件
．產品清單
．材料清單和材料文件
．屠夫清單（特別是屠宰場）
．產品矩陣
．HAS 手冊
．工藝流程圖
．生產設施地址清單
．清真政策傳播的證據
．內部培訓的證據和內部審計的證據。
9. 註冊清真證書（上傳數據）
10. 監控清真認證過程的預審核和合同付款
11. 執行審計
12. 執行審計後監控
13. 清真證書有效期為4年
14. 提交清真證書的申請者必須：
．提供正確、清晰和真實的信息
．在清真和非清真產品之間分離加工、儲存、包裝、經銷、銷售和展示的位置、場所和設備
．向 BPJPH 報告材料成分的變化
15.獲得清真證書的經營者必須：
．在獲得清真證書的產品上貼上清真標籤
．保持已獲得清真證書的產品的清真
．將清真產品和非清真產品的加工、儲存、包裝、經銷、銷售和展示的地點、場所和設備分開
．如果清真證書的有效期已過，須更新清真證書
．向 BPJPH 報告材料成分的變化
16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。
已獲得清真證書的經營者必須在以下位置貼上清真標籤：
．產品包裝
．產品的特定部分
．產品的具體位置
．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。
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.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-45
HLF-ID-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
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：
須由印尼當地的公司名義申請醫療器材產品許可證。
在印尼生產、進口、組裝和/或重新包裝以供經銷的任何醫療器材、體外診斷醫療器材必須具有產品許可證，申請人須為當地合法成立的公司實體或商業實體，進口醫療器材、體外診斷醫療器材的產品許可申請人：
1. 獨家代理/獨家經銷商/獨家經銷商。
2. 經銷商(PAK)、進口商(PKRT)：擁有製造商或委託人的書面任命，並被授權在印尼註冊醫療器材、體外診斷醫療器材。
3. 經銷商(PAK)、進口商(PKRT)：作為擁有與製造商書面協議的產品所有者。
4. 進行組裝、重新包裝的經銷商(PAK) 。
申請產品許可證需要具備：
1.符合良好的生產規範。
2.經臨床評估報告和/或任何其他證據證明的安全性、有效性。
3.劑量不超過現行標準、要求和規定的含量限值。
4.根據現行標準、要求和規定，不使用任何違禁材料。
5. 必須附有原產國衛生當局簽發的自由銷售證書(CFS)，如果未在原產國註冊，則 CFS 可由原產國的任何其他機構簽發。證明需要顯示：
．商品名稱/品牌名稱
．產品類型
．製造商的名稱和地址
．有效期
申請流程
1. 藥房和醫療器材總局 (Regalkes) 電子系統網頁提交申請資料。
網頁：http://regalkes.kemkes.go.id/
2. 申請所需文件
行政要求
．生產證書/PAK 許可證
．作為獨家代理/獨家經銷商/獨家經銷商的授權書
．相關機構出具的自由銷售證明(CFS) (進口產品)
．質量管理體系文件(ISO 13485、ISO 9001、CE等)
．商標證書(如果有)
技術要求
．產品信息：材料、配方、器材信息、描述和特徵、標準及生產工藝、適應症、預期用途和使用說明、禁忌症、警告、小心、不良的潛在影響。
．規格要求及質量保證：原材料規格和材料安全數據表 (MSDS)
．包裝規格
．設備性能規格
．實驗室測試結果：分析證書(CoA)、穩定性測試、無菌測試、電力安全測試
．臨床前、臨床研究結果(針對 C 、 D 類醫療器材和體外診斷醫療器材)
．風險管理
特殊要求
．輻射材料安全
．國家參考實驗室對愛滋病毒產品的臨床試驗
標籤要求
．標籤樣例及說明
．使用說明、材料安裝和維護說明
上市後要求
．不良事件和投訴的記錄和管理程序
3. 申請人須對電子系統上傳的任何申請文件的完整性、真實性和有效性負責。
專家將對醫療器材產品許可證、體外診斷醫療器材的每項申請進行行政、技術要求的評估、驗證，執行期如下：
．A類15天以內。
．B類30天以內。
．C類30天以內。
．D類45天以內。
4. 產品許可證以電子形式簽發自行打印，如遇不可抗力，可紙本簽發。
5. PKRT 作為非稅收國家收入需要由電子支付繳納費用。
6. 產品許可證有效期最長為5年。
7. 如果產品許可證申請是由指定為獨家代理/獨家經銷商/獨家經銷商和/或授權註冊的 PAK 或 PKRT 公司提交的，則產品許可證的有效期遵循該任命或授權的期限，至少2年、最多5年。
8. 如果醫療器材、體外診斷醫療器材由製造商通過 OEM 生產，其產品許可證的有效期不超過3年。
9. 產品許可證的有效期可以在滿足任何要求的情況下進行更新。
包裝與標示
醫療器材與體外診斷醫療器材標籤和信息必須說明安全性、有效性/性能、使用說明和/或任何其他信息的條件。所需資料：
1. 商品名稱/品牌名稱
2. 產品許可證號
3. 產品類型
4. 生產商/製造商的名稱和地址
5. PKRT 進口商的名稱和地址
6. 批號/生產代碼/序列號
7. 無菌一詞以及如何對無菌產品進行滅菌(如果適用)
8. 產品規格
9. 使用目的和使用說明
10. 有效期(如果適用)
11. 使用的活性材料清單及其百分比
12. 淨重或淨含量
13. 生產代碼
14. 使用/製備說明
15. 小心和警告
16. 某些醫療器材和體外診斷醫療器材的警告標籤，例如僅限專業使用或字母符號P，黑色背景白色字體，必須由合格人員使用。
17.若包含活性物質的淨含量、成分和含量、禁忌症、注意和警告標籤或 KTD/副作用的聲明，則標籤和信息必須說明相同的。
18.上述內容必須以印度尼西亞語呈現，若沒有對應詞或無法創建對應詞或用於海外貿易，則允許使用印尼語以外的其他語言。
19.醫療器材、體外診斷醫療器材的標籤和信息禁止使用以下詞語：
．最高級的詞，例如最、非常、第一、唯一、頂級、有效、超級、卓越、驚人、神奇、完美或帶有-est（最）後綴的詞，和/或解釋這種優越性的相同含義的詞。
．諸如無菌、無蚊蟲、安全、根除、芳香療法、抗衰老、治療、預防登革熱、抗病毒、放鬆、醫生推薦和/或任何其他同義詞。
．撰寫百分比或其他聲明以彰顯產品的有效性。
．在任何家用農藥產品中使用家庭、兒童、嬰兒、柔軟、保濕和/或任何其他具有相同含義的詞語。
清真認證程序
1. 產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。
2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。
3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。
4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。
5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。
6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。
7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。
8. 認證文件
．產品清單
．材料清單和材料文件
．屠夫清單（特別是屠宰場）
．產品矩陣
．HAS 手冊
．工藝流程圖
．生產設施地址清單
．清真政策傳播的證據
．內部培訓的證據和內部審計的證據。
9. 註冊清真證書（上傳數據）
10. 監控清真認證過程的預審核和合同付款
11. 執行審計
12. 執行審計後監控
13. 清真證書有效期為4年
14. 提交清真證書的申請者必須：
．提供正確、清晰和真實的信息
．在清真和非清真產品之間分離加工、儲存、包裝、經銷、銷售和展示的位置、場所和設備
．向 BPJPH 報告材料成分的變化
15.獲得清真證書的經營者必須：
．在獲得清真證書的產品上貼上清真標籤
．保持已獲得清真證書的產品的清真
．將清真產品和非清真產品的加工、儲存、包裝、經銷、銷售和展示的地點、場所和設備分開
．如果清真證書的有效期已過，須更新清真證書
．向 BPJPH 報告材料成分的變化
16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。已獲得清真證書的經營者必須在以下位置貼上清真標籤：
．產品包裝
．產品的特定部分
．產品的具體位置
．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。
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.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-55
HLF-ID-60
經過核准登記的醫療器材，進口到印尼要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
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：
海關流程
1. 至海關總局註冊並取得海關註冊編號(NIK)
網頁：https://customer.beacukai.go.id/index.html?page=registrasi
2. 取得進口許可證，有效期為5年，其後可以續期。
3. 進口許可證可透過電子資料聯通(EDI)管理，並分為兩類：
．一般進口商註冊編號(API-U)：適用於普通貿易
．生產型進口商註冊編號(API-P) ：適用於進口自用商品的進口商，例如原材料、輔助材料及/或其他用作支援生產過程的產品
4. 填妥進口申報表並向海關總局提交，包含：
．進口申報表
．發票
．包裝清單
．提單
．保險保單
．進口關稅
．相關稅項收據等。
5. 在取得進出口商代碼和進口許可證後，進口商應確定並申報進口物品的來源或產地，並遵從清關手續。
6. 計算進口關稅率(輸入任何進口貨物的進口商，應自行評估對此類貨物徵收的關稅)
7. 須提供資料
．姓名、完整的營業地址
．保存或儲存通知貨物的場所的情況和描述
．貨物的詳情
．日期以及收到此類貨物的人的姓名和完整地址
．貨物所有人的姓名
．貨物的名稱
．取出貨物場所的位置
．通知貨物被運往場所的位置
．運輸工具(如果使用機動車輛運輸通知貨物，需填寫機動車輛的登記號。）
．運輸路線、開始運輸的時間日期、可能到達目的地的時間和日期
．銷售或轉讓通知貨物的人的姓名和完整的營業地址
．向其出售或轉讓通知貨物的人的姓名和完整地址
．出售或轉讓的時間和日期
．貨物的數量、市場價格
．序列號(如果有)
．批號(如果有)
．專利號(如果有)
．製造商、原產國(如果有)
．品牌(如果有)
．商標(如果有)
8.貨物在獲准入境前不得從船上卸貨
9.僅在批准的地點卸貨和裝貨
10.進口商在出示入境單時應就該入境單的內容的真實性作出並簽署聲明，並應為支持該聲明，向有關官員出示發票（如有）以及可能規定的與進口貨物有關的其他文件
11. 入境單的進口商應確保以下事項
．提供信息的準確性和完整性
．任何支持它的文件的真實性和有效性
．遵守本法或當時有效的任何其他法律對貨物的限制或禁止
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
【參考連結】
https://www.beacukai.go.id/index.html
HLF-ID-70
印尼醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
在印尼，醫療器材欲取得產品許可，製造商需符合GMP，並且需有質量管理體系文件(ISO 13485、ISO 9001、CE等)證明，需繳交相關資料：
行政要求
．生產證書/PAK 許可證
．作為獨家代理/獨家經銷商/獨家經銷商的授權書
．相關機構出具的自由銷售證明(CFS) (進口產品)
．質量管理體系文件(ISO 13485、ISO 9001、CE等)
．商標證書(如果有)
技術要求
．產品信息：材料、配方、器材信息、描述和特徵、標準及生產工藝、適應症、預期用途和使用說明、禁忌症、警告、小心、不良的潛在影響。
．規格要求及質量保證：原材料規格和材料安全數據表 (MSDS)
．包裝規格
．設備性能規格
．實驗室測試結果：分析證書(CoA)、穩定性測試、無菌測試、電力安全測試
．臨床前、臨床研究結果(針對 C 、 D 類醫療器材和體外診斷醫療器材)
．風險管理
特殊要求
．輻射材料安全
．國家參考實驗室對愛滋病毒產品的臨床試驗
標籤要求
．標籤樣例及說明
．使用說明、材料安裝和維護說明
上市後要求
．不良事件和投訴的記錄和管理程序
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
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-75
HLF-ID-77
HLF-ID-80
外國子公司進口醫療器材後，如果委託印尼的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
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：
須以印尼當地公司名義申請醫療器材經銷許可證(DAK)。
責任：
1. 產品許可證持有人必須負責任何醫療器材、體外診斷醫療器材銷售的產品責任。
2. 任何通過 OEM 生產的醫療器材、體外診斷醫療器除了產品許可證持有人負有責任，產品所有者也有責任。
3. 任何委託生產的醫療器材、體外診斷醫療器材除了產品許可證持有人負有責任，受委託的製造商也有責任。
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.
【參考連結】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-85
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