印度醫療器材登記法規問題集
Email：del4ww@evershinecpa.com
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印度永輝BPO有限公司
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The Engaging Manager Punit Negi, Indian citizenship
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linkedin address:Dale Chen Linkedin
HLF-TW-10
請問印度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 India? 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：
在印度，醫療器材由中央藥品標準控制組織 (CDSCO)轄下的印度藥品總局 (DCGI) 監管，對於醫療器材的進口、生產場所、產品皆需要在DCGI進行註冊。
醫療器材是指任何設備，包括儀器、裝置、器具、植入物、材料或其他物品，包括軟體、硬體，可以是單獨或組合使用於人體或動物，因為無法通過藥理學、免疫學或代謝手段達到預期目的，可以通過設備輔助其預期功能，用於以下一項或多項目的：
1. 任何疾病或病症的診斷、預防、監測、治療或緩解。
2. 任何傷害或殘疾的診斷、監測、治療、緩解或援助。
3. 解剖或生理過程的調查、替換或修改或支持。
4. 支持或維持生命。
5. 醫療器材消毒。
6. 控制受孕。
醫療器材依據風險程度分成四類
1. A等級(低風險)：未公告強制列檢的醫材品項(例如：血壓計、繃帶、紗布等)
2. B等級(中風險)：現行分類標準公告B等級品項(例如：球囊導管、支氣管導管等)
3. C等級(中高風險)：現行分類標準公告C等級品項(例如：呼吸機、生化貼片、測試試劑/試劑盒等)
4. D等級(高風險)：現行分類標準公告D等級品項(例如：人工心臟瓣膜、椎間盤假體等)
在印度境內製造A等級(低風險)、B等級(中風險)醫療器材以供販售、流通使用或租賃之醫材製造商，依法應向省立藥品管制局申請製造許可證；製造C等級(中高風險)、D等級(高風險)醫療器材以供販售、流通使用或租賃之醫材製造商，依法應向CDSCO申請製造許可證。
In India, medical devices are regulated by the Directorate General of Drugs of India (DCGI) under the Central Drug Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, and the import, production sites and products of medical devices need to be registered with DCGI.
Medical device means any device, including instruments, devices, appliances, implants, materials, or other items, including soft, hard The means achieve the intended purpose, and the intended function can be assisted by the equipment for one or more of the following:
1. Diagnosis, prevention, monitoring, treatment or mitigation of any disease or condition.
2. Diagnosis, monitoring, treatment, relief or assistance of any injury or disability.
3. The investigation, replacement or modification or support of an anatomical or physiological process.
4. Supporting or sustaining life.
5. Medical device disinfection.
6. Controlling conception.
Medical devices are classified into four categories according to the degree of risk
1. Class A (low risk): medical materials items that have not been announced for mandatory inspection (such as sphygmomanometers, bandages, gauze, etc.)
2. Class B (medium risk): The current classification standard announces B grade items (for example: balloon catheter, bronchial catheter, etc.)
3. Class C(medium-high risk): C-level items announced in the current classification standard (for example: ventilators, biochemical patches, test reagents/kits, etc.)
4. Class D(high risk): the current classification standard announces D grade items (for example: artificial heart valve, intervertebral disc prosthesis, etc.)
Manufacturers of medical materials that manufacture Class A (low risk) and Class B (medium risk) medical devices for sale, circulation or lease in India shall apply for a manufacturing license to the Provincial Drug Control Bureau according to law; manufacturing Class C Manufacturers of medical materials (medium-high risk) and D-level (high-risk) medical device for sale, circulation or lease should apply to CDSCO for a manufacturing license according to law.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Home/
HLF-TW-20
外國公司要到印度銷售醫療器材，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 India, 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：
無須申請營業許可證
No business license is required.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-25
假如需要辦理，請問印度有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無須申請營業許可證
HLF-TW-30
外國公司要到印度銷售醫療器材，可以指派印度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 India, can it assign an India 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。可指定印度當地公司成為代理人並註冊醫療器材進口許可證。
當發生不良事件，主管機關有權力要求進口商立即啟動召回，以防用戶或患者的健康構成風險。進口商有責任說明其撤回的原因、發送通知，並且需要提交定期安全性更新報告並建立警戒系統。
Yes. The medical device import license must be registered in the name of a local company in India.
When an adverse event occurs, the competent authority has the power to require the importer to initiate a recall immediately, in case the health of the user or patient poses a risk. Importers are responsible for explaining the reasons for their withdrawal, sending notices, and are required to submit regular security updates and establish a vigilance system.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-35
HLF-TW-40
外國公司銷售到印度醫療器材本身，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 India?
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，須以印度當地公司名義註冊醫療器材進口許可證。
流程
1. 至CDSCO設立網頁註冊：
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. 申請者需上傳以下文件進行註冊：
．身份證明詳情
．聲明
．公司地址詳情（公司註冊證書）
．製造許可證和批發許可證的副本（如果沒有，則上傳等同的證明）
3. 完成驗證後登錄，繳交以下註冊文件，文件須以英語提供。
註冊文件
1. 當地公司/企業名稱、地址
2. 醫療器材內容
．通用名稱
．型號
．用途
．醫療器材分類
．結構材料
．尺寸
．有效期
．無菌或非無菌
．品牌
3. 由國家認證機構認證委員會或國際認證論壇認可此類醫療器材符合 ISO 13485 標準的證明，進口商註冊醫療器材後，必須嚴格遵守其成文的質量管理體系。
如果CDSCO認定境外製造廠QMS之符合性存在疑慮時，可以要求實施評估、產品測試或檢驗程序，此時，如果CDSCO要求必須透過海外查廠的方式確認境外製造廠QMS之符合性，依法應由進口商負擔海外查廠之費用。
4. 製造商承諾書，聲明申請人提供的信息真實、可靠。
5. 原產國的自由銷售證明。
6. 進口商提出的產品註冊由DCGI審核，處理申請的規定時間自申請之日起最多 9 個月。
7. 所有醫療器材（A、B、C、D 類）的風險分類由 DCGI 認定。註冊C、D類器材需要證明其安全性。
CDSCO審核安全性與有效性之文件要求，會依照產品原產國是否來自先進國家而有差異。
產品原產國若屬先進國家，依法提出前述自由銷售許可或原產國實施臨床測試數據資料作為證明文件即可，但若進口醫療器材之原產國為先進國家以外之其他國家，則必須在印度實施臨床測試，以確認產品之安全性與有效性。
8. 放寬條件
．2020 年 4 月 1 日至 2021 年 9 月 30 日製造、進口、分銷或銷售新申報的醫療器材無需註冊或許可。
．2021 年 10 月 1 日至 2022 年 9 月 30 日進口或製造的醫療器材需要註冊，但不需要許可證。
．2022 年 10 月 1 日至 2023 年 9 月 30 日製造、進口、分銷或銷售 A 類或 B 類醫療器材需要許可證，但製造、進口、分銷或銷售 C 類或 D 類醫療器材不需要許可證。
．2023 年 10 月 1 日之後製造、進口、分銷或銷售 C 類和 D 類醫療器材也需要許可證。
9. 2017進口許可證除非提前暫停或取消，否則將永久有效。
標籤
應以不褪色的墨水將下列細節印在標籤上、醫療器材的貨架包裝上或醫療器材的每個外殼上：
1. 醫療器材的名稱
2. 用戶識別設備及其使用所需的詳細信息
3. 製造商名稱和製造場所的地址
4. 正確說明重量、尺寸、體積、單位數量（視情況而定）和包裝中包含的淨數量(以公製表示)。
5. 製造和到期的月份和年份（或者標籤應標明產品的保質期）： 如果是無菌器材，滅菌日期可以作為器材的製造日期。如果器材由不銹鋼或鈦等穩定材料製成，並且以非無菌方式提供，則可能不需要有效期。
6. 提供含有藥用或生物物質的指示(如果適用)。
7. 帶有“批號”字樣的獨特批號。
8. 指明適用於該器材的任何特殊儲存或處理條件(如果適用)。
9. 如果器材作為無菌產品提供，則說明其無菌狀態和滅菌方法。
10. 給予警告或預防措施以引起醫療器材用戶的注意。
11. 如果設備是一次性使用的需標記。
12. 如果醫療器材打算作為免費樣品分發給醫療專業人員，則在器材標籤上套印“醫師樣品—不得出售”字樣。
13. 標示製造許可證號或“Mfg. Lic. No.” 或 “M. L”。
14. 進口器材可以用貼紙的方式提供進口許可證號、進口商名稱與地址、實際製造場所的地址、製造日期(前提是標籤有印度標準局或國際標準化組織 (ISO) 認可的符號來代替文本，並且設備安全不會因用戶缺乏理解而受到影響。)
15. 對於無法清晰列出信息的小型醫療器材，應包括產品標識和安全所需的信息。
16. 設備標識符號：是指全球貿易項目編號。
17. 生產標識符號：是指序列號、批號。
18. 標籤應以英文提供。
The medical device import license must be registered in the name of a local company in India.
Process
1. Set up web registration at CDSCO:
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. Applicants are required to upload the following documents for registration:
．ID Details
．Statement
．Company Address Details (Company Registration Certificate)
．Copies of Manufacturing License and Wholesale License (upload equivalent if not available)
3. After completing the verification, log in, and submit the following registration documents. The documents must be provided in English.
Required Documents for Registration
1. Local Company/Business Name, Address
2. Contents of Medical Devices
．Generic name
．Model
．Purpose
．Classification of medical device
．Structural materials
．Size
．Validity period
．Sterile or Non-sterile
．Brand
3. Certification by the National Accreditation Body Accreditation Committee or International Accreditation Forum that such medical devices conform to the ISO 13485 standard, and importers must strictly abide by their documented quality management system after registering the medical device. If CDSCO determines that there are doubts about the compliance of the QMS of the overseas manufacturer, it may request the implementation of assessment, product testing or inspection procedures. The importer shall bear the cost of overseas factory inspection.
4. A letter of commitment from the manufacturer, stating that the information provided by the applicant is true and reliable.
5. Proof of free sale in the country of origin.
6. The product registration proposed by the importer is reviewed by DCGI, and the prescribed time for processing the application is a maximum of 9 months from the date of application.
7. Risk classification for all medical devices (Class A, B, C, D) is determined by DCGI. Registration of Class C and D equipment requires proof of its safety. The documentation requirements for CDSCO to review safety and efficacy vary depending on whether the country of origin of the product is from an advanced country. If the country of origin of the product is an advanced country, it is sufficient to submit the aforementioned free sales license or the implementation of clinical test data in the country of origin as a certification document. However, if the country of origin of imported medical device is a country other than an advanced country, it must be India conducts clinical tests to confirm the safety and efficacy of products.
8. Relax conditions
．No registration or license is required to manufacture, import, distribute or sell newly declared medical devices from April 1, 2020 to September 30, 2021.
．Medical devices imported or manufactured between October 1, 2021 and September 30, 2022 require registration, but no license.
．A license is required to manufacture, import, distribute, or sell Class A or B medical devices from October 1, 2022 to September 30, 2023, but no license is required to manufacture, import, distribute or sell Class C or D medical devices .
．A license is also required to manufacture, import, distribute, or sell Class C and D medical devices after October 1, 2023.
9. The 2017 import license will be valid in perpetuity unless suspended or cancelled in advance.
Label
The following details shall be printed in non-fading ink on the label, on the shelf packaging of the medical device, or on each housing of the medical device:
1. The name of the medical device
2. User identification of the device and details required for its use
3. Manufacturer’s name and address of manufacturing site
4. Correctly state the weight, dimensions, volume, unit quantity (as applicable) and net quantity (in metric) contained in the package.
5. Month and Year of Manufacture and Expiration (or the label should indicate the expiration date of the product): In the case of sterile equipment, the sterilization date may be used as the date of manufacture of the equipment. If the device is made of a stable material such as stainless steel or titanium, and is supplied in a non-sterile manner, an expiration date may not be required.
6. Provide indication of containing medicinal or biological substances (if applicable).
7. Unique lot number with the word “Lot”.
8. Indicate any special storage or handling conditions applicable to the equipment, if applicable.
9. If the device is supplied as a sterile product, state its sterile condition and method of sterilization.
10. Give warnings or precautions to the attention of the user of the medical device.
11. Mark the device if it is for single use.
12. If the medical device is intended to be distributed as a free sample to medical professionals, overprint the words “Physician Sample – Not For Sale” on the device label.
13. Indicate the manufacturing license number or “Mfg. Lic. No.” or “M. L”.
14. Imported equipment may provide the import license number, importer’s name and address, address of the actual manufacturing site, date of manufacture in the form of a sticker (provided that the label has a symbol approved by the Bureau of Indian Standards or the International Organization for Standardization (ISO) in place of the text) , and device security is not compromised by lack of user understanding.)
15. For small medical devices whose information cannot be clearly listed, the information required for product identification and safety should be included.
16. DT Symbol: means the Global Trade Item number.
17. Production identification number: refers to the serial number, batch number.
18. Labels shall be available in English.
【參考連結】
HLF-TW-45
HLF-TW-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：
須以印度當地公司名義註冊醫療器材進口許可證。
流程
1. 至CDSCO設立網頁註冊：
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. 申請者需上傳以下文件進行註冊：
．身份證明詳情
．聲明
．公司地址詳情（公司註冊證書）
．製造許可證和批發許可證的副本（如果沒有，則上傳等同的證明）
3. 完成驗證後登錄，繳交以下註冊文件，文件須以英語提供。
醫療器材註冊所需文件
1. 當地公司/企業名稱、地址
2. 醫療器材內容
．通用名稱
．型號
．用途
．醫療器材分類
．結構材料
．尺寸
．有效期
．無菌或非無菌
．品牌
3. 由國家認證機構認證委員會或國際認證論壇認可此類醫療器材符合 ISO 13485 標準的證明，進口商註冊醫療器材後，必須嚴格遵守其成文的質量管理體系。如果CDSCO認定境外製造廠QMS之符合性存在疑慮時，可以要求實施評估、產品測試或檢驗程序，此時，如果CDSCO要求必須透過海外查廠的方式確認境外製造廠QMS之符合性，依法應由進口商負擔海外查廠之費用。
4. 製造商承諾書，聲明申請人提供的信息真實、可靠。
5. 原產國的自由銷售證明。
6. 進口商提出的產品註冊由DCGI審核，處理申請的規定時間自申請之日起最多 9 個月。
7. 所有醫療器材（A、B、C、D 類）的風險分類由 DCGI 認定。註冊C、D類器材需要證明其安全性。CDSCO審核安全性與有效性之文件要求，會依照產品原產國是否來自先進國家而有差異。產品原產國若屬先進國家，依法提出前述自由銷售許可或原產國實施臨床測試數據資料作為證明文件即可，但若進口醫療器材之原產國為先進國家以外之其他國家，則必須在印度實施臨床測試，以確認產品之安全性與有效性。
8. 放寬條件
．2020 年 4 月 1 日至 2021 年 9 月 30 日製造、進口、分銷或銷售新申報的醫療器材無需註冊或許可。
．2021 年 10 月 1 日至 2022 年 9 月 30 日進口或製造的醫療器材需要註冊，但不需要許可證。
．2022 年 10 月 1 日至 2023 年 9 月 30 日製造、進口、分銷或銷售 A 類或 B 類醫療器材需要許可證，但製造、進口、分銷或銷售 C 類或 D 類醫療器材不需要許可證。
．2023 年 10 月 1 日之後製造、進口、分銷或銷售 C 類和 D 類醫療器材也需要許可證。
9. 2017進口許可證除非提前暫停或取消，否則將永久有效。
標籤
應以不褪色的墨水將下列細節印在標籤上、醫療器材的貨架包裝上或醫療器材的每個外殼上：
1. 醫療器材的名稱
2. 用戶識別設備及其使用所需的詳細信息
3. 製造商名稱和製造場所的地址
4. 正確說明重量、尺寸、體積、單位數量（視情況而定）和包裝中包含的淨數量(以公製表示)。
5. 製造和到期的月份和年份（或者標籤應標明產品的保質期）： 如果是無菌器材，滅菌日期可以作為器材的製造日期。如果器材由不銹鋼或鈦等穩定材料製成，並且以非無菌方式提供，則可能不需要有效期。
6. 提供含有藥用或生物物質的指示(如果適用)。
7. 帶有“批號”字樣的獨特批號。
8. 指明適用於該器材的任何特殊儲存或處理條件(如果適用)。
9. 如果器材作為無菌產品提供，則說明其無菌狀態和滅菌方法。
10. 給予警告或預防措施以引起醫療器材用戶的注意。
11. 如果設備是一次性使用的需標記。
12. 如果醫療器材打算作為免費樣品分發給醫療專業人員，則在器材標籤上套印“醫師樣品—不得出售”字樣。
13. 標示製造許可證號或“Mfg. Lic. No.” 或 “M. L”。
14. 進口器材可以用貼紙的方式提供進口許可證號、進口商名稱與地址、實際製造場所的地址、製造日期(前提是標籤有印度標準局或國際標準化組織 (ISO) 認可的符號來代替文本，並且設備安全不會因用戶缺乏理解而受到影響。)
15. 對於無法清晰列出信息的小型醫療器材，應包括產品標識和安全所需的信息。
16. 設備標識符號：是指全球貿易項目編號。
17. 生產標識符號：是指序列號、批號。
18. 標籤應以英文提供。
The medical device import license must be registered in the name of a local company in India.
Process
1. Set up web registration at CDSCO:
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. Applicants are required to upload the following documents for registration:
．ID Details
．Statement
．Company Address Details (Company Registration Certificate)
．Copies of Manufacturing License and Wholesale License (upload equivalent if not available)
3. After completing the verification, log in, and submit the following registration documents. The documents must be provided in English.
Required Documents for Medical Device Registration
1. Local Company/Business Name, Address
2. Contents of Medical Devices
．Generic name
．Model
．Purpose
．Classification of medical device
．Structural materials
．Size
．Validity period
．Sterile or Non-sterile
．Brand
3. Certification by the National Accreditation Body Accreditation Committee or International Accreditation Forum that such medical devices conform to the ISO 13485 standard, and importers must strictly abide by their documented quality management system after registering the medical device. If CDSCO determines that there are doubts about the compliance of the QMS of the overseas manufacturer, it may request the implementation of assessment, product testing or inspection procedures. The importer shall bear the cost of overseas factory inspection.
4. A letter of commitment from the manufacturer, stating that the information provided by the applicant is true and reliable.
5. Proof of free sale in the country of origin.
6. The product registration proposed by the importer is reviewed by DCGI, and the prescribed time for processing the application is a maximum of 9 months from the date of application.
7. Risk classification for all medical devices (Class A, B, C, D) is determined by DCGI. Registration of Class C and D equipment requires proof of its safety. The documentation requirements for CDSCO to review safety and efficacy vary depending on whether the country of origin of the product is from an advanced country. If the country of origin of the product is an advanced country, it is sufficient to submit the aforementioned free sales license or the implementation of clinical test data in the country of origin as a certification document. However, if the country of origin of imported medical device is a country other than an advanced country, it must be India conducts clinical tests to confirm the safety and efficacy of products.
8. Relax conditions
．No registration or license is required to manufacture, import, distribute or sell newly declared medical devices from April 1, 2020 to September 30, 2021.
．Medical devices imported or manufactured between October 1, 2021 and September 30, 2022 require registration, but no license.
．A license is required to manufacture, import, distribute, or sell Class A or B medical devices from October 1, 2022 to September 30, 2023, but no license is required to manufacture, import, distribute or sell Class C or D medical devices .
．A license is also required to manufacture, import, distribute, or sell Class C and D medical devices after October 1, 2023.
9. The 2017 import license will be valid in perpetuity unless suspended or cancelled in advance.
Label
The following details shall be printed in non-fading ink on the label, on the shelf packaging of the medical device, or on each housing of the medical device:
1. The name of the medical device
2. User identification of the device and details required for its use
3. Manufacturer’s name and address of manufacturing site
4. Correctly state the weight, dimensions, volume, unit quantity (as applicable) and net quantity (in metric) contained in the package.
5. Month and Year of Manufacture and Expiration (or the label should indicate the expiration date of the product): In the case of sterile equipment, the sterilization date may be used as the date of manufacture of the equipment. If the device is made of a stable material such as stainless steel or titanium, and is supplied in a non-sterile manner, an expiration date may not be required.
6. Provide indication of containing medicinal or biological substances (if applicable).
7. Unique lot number with the word “Lot”.
8. Indicate any special storage or handling conditions applicable to the equipment, if applicable.
9. If the device is supplied as a sterile product, state its sterile condition and method of sterilization.
10. Give warnings or precautions to the attention of the user of the medical device.
11. Mark the device if it is for single use.
12. If the medical device is intended to be distributed as a free sample to medical professionals, overprint the words “Physician Sample – Not For Sale” on the device label.
13. Indicate the manufacturing license number or “Mfg. Lic. No.” or “M. L”.
14. Imported equipment may provide the import license number, importer’s name and address, address of the actual manufacturing site, date of manufacture in the form of a sticker (provided that the label has a symbol approved by the Bureau of Indian Standards or the International Organization for Standardization (ISO) in place of the text) , and device security is not compromised by lack of user understanding.)
15. For small medical devices whose information cannot be clearly listed, the information required for product identification and safety should be included.
16. DT Symbol: means the Global Trade Item number.
17. Production identification number: refers to the serial number, batch number.
18. Labels shall be available in English.
【參考連結】
HLF-TW-55
HLF-TW-60
經過核准登記的醫療器材，進口到印度要檢附什麼文件？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 India? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
需取得進出口代碼 (IEC)及進口商許可證才可以進口醫療器材至印度。
無銷售許可證，但經銷商必須保存所有銷售紀錄。
進出口代碼 (IEC)
IEC 編號是對外貿易總幹事頒發給印度公司的10位數代碼。每個從事進出口業務的個人或實體都必須獲得 IEC。
它具有終身有效期，大約需要 15 天才能簽發。
1.網頁註冊：https://www.dgft.gov.in/CP/
．獲得 IEC 的公司的性質可以是以下任何一種：獨資企業、合夥企業、有限責任合夥企業、有限公司、信託、HU”。
引入 GST 後，IEC 編號與公司的 PAN 相同。IEC 將由 DGFT 單獨發布。
2.簽署聲明。
3.支付IEC費用。
4.簽發IEC代碼。
進口流程
1.於印度海關電子網關 (ICEGATE)註冊會員
印度海關電子網關 (ICEGATE) 是印度海關中央間接稅和海關委員會 (CBIC) 的國家門戶，以電子方式向貿易、貨運承運人和其他貿易夥伴提供電子申報服務。網頁：https://www.icegate.gov.in/index.html
．申請人
．公司名稱
．地址
．城市
．密碼
．電話、傳真號碼、電子信箱
．類別：進口商/出口商等
．清關位置
．內容、發貨地、收貨地
．貨物的詳情、貨物登記
．商業發票
．合約
．提單
．QMS證明
．標籤樣本(需提供翻譯文件)
．收方公司IEC Code
．收貨人個人證件影本(PAN：永久帳戶號/TAN：收稅及減稅帳號/身份證/護照)
．通過電子現金分類賬支付和電子稅收信用分類。
2.清關需要文件
．商業發票
．裝箱單
．分析證書
．原產地證書
．空運提單/貨運提單
．保險憑證
．貨運證明
．目錄/技術說明
．進口許可證
．追蹤貨件
．原產國自由銷售證明
．質量管理體系證書/完整質量保證證書/生產質量保證證書的公證副本
．公告機構/國家監管機構或其他主管機構在過去三年內進行的最新檢查或審計報告的副本(如果具備)
3.必須在2-3天內清關。
4.完成入境單評估後、文件通過審查，貨物將進行電子檢查，經由海關人員批准後取得通關提貨。
An Import and Export Code (IEC) and an importer’s license are required to import medical devices into India.No sales license, but distributors must keep all sales records.
Import/Export Code (IEC)
The IEC number is a 10-digit code issued by the Director General of External Trade to Indian companies. Every person or entity engaged in importing or exporting business must obtain IEC. It is valid for life and takes approximately 15 days to issue.
1. Web registration: https://www.dgft.gov.in/CP/
．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.
2. Sign the statement.
3. Pay the IEC fee.
4. Issue the IEC code.
Import procedure
1. Register as a member in India Customs Electronic Gateway (ICEGATE)
The Indian Customs Electronic Gateway (ICEGATE) is the national portal of the Central Indirect Tax and Customs Board (CBIC) of Customs of India, providing electronic declaration services to trades, freight carriers and other trading partners electronically. URL: https://www.icegate.gov.in/index.html
．Applicant
．Company Name
．Address
．City
．Password
．Telephone, fax number, e-mail
．Category: Importer/Exporter etc.
．Customs clearance location
．Contents, place of origin, place of receipt
．Details of cargo, cargo registration
．Commercial invoice
．Contract
．B/L
．QMS certificate
．Label sample (translation file required)
．Receiving company IEC Code
．Photocopy of the consignee’s personal ID (PAN: Permanent Account Number/TAN: Tax and Tax Deduction Account Number/ID Card/Passport)
．Payment via electronic cash ledger and electronic tax credit sorting.
2. Customs clearance requires documents
．Commercial invoice
．Packing List
．Certificate of Analysis
．Certificate of Origin
．Air Waybill / Freight Bill of Lading
．Certificate of Insurance
．Shipping certificate
．Catalog/Technical Notes
．Import permit
．Track your shipment
．Certificate of Free Sale in the Country of Origin
．Notarized copy of quality management system certificate/full quality assurance certificate/production quality assurance certificate
．A copy of the latest inspection or audit report conducted by the Notified Body/National Regulatory Authority or other competent authority within the past three years (if available)
3. Customs clearance must be done within 2-3 days.
4. After completing the assessment of the entry form and the documents passing the review, the goods will be electronically inspected, and the goods will be cleared and picked up after being approved by the customs personnel.
【參考連結】
https://www.cbic.gov.in/htdocs-cbec/customs
HLF-TW-70
印度醫療器材審核機構，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：
質量管理體系規範(QMS)
醫療器材的製造應符合要求，建立、記錄、實施和維護質量管理並保持其有效性，文件應包括：
1. 質量方針和質量目標的書面陳述。
2. 質量手冊。
．質量管理體系的範圍，包括任何排除或不適用或兩者兼有的細節和理由。
．為質量管理體系建立的文件化程序，或對其的引用。
．對質量管理體系過程之間相互作用的描述。 包含設施、人員和其他細節的具體信息。
3. 文件化程序。
4. 製造商為確保其過程的有效規劃、操作和控制所需的文件。
5. 程序、活動或特殊安排的記錄。
6. 文件控制應按照記錄控制中給出的要求進行控制。文件應由適當的授權人員批准、簽署並註明日期。
應建立形成文件的程序來定義所需的控制
．在發布前充分審查和批准文件
．必要時審查和更新文件並重新批准文件
．確保識別文件的變更和目前的修訂狀態
．確保申請文件所使用的版本是合適的
．確保文件保持清晰和易於識別
．確保識別來自外部的文件並控制其分發
．防止對過時文件的意外使用
7. 記錄控制：應在醫療器材有效期屆滿後至少保留一年的記錄。
8. 管理責任：製造商的高層管理人員應提供其致力於開發和實施質量管理系統的承諾，並通過以下方式維持其有效性。
．與員工溝通滿足客戶以及法定和監管要求的重要性
．制定質量政策
．確保建立優質目標
．進行管理評論
．確保資源的可用性
9. 質量方針：製造商的最高管理者應確保質量方針
．適合製造設施的目的
．包括遵守要求和保持質量管理體係有效性的承諾
． 提供建立和審查質量目標的框架
．在製造商組織內溝通
．審查持續適用性
10. 質量目標：製造商的高層管理人員應確保在製造組織內的相關功能和級別建立質量目標，包括滿足產品要求所需的目標。質量目標應可衡量，並與質量政策一致。
11. 資源提供：製造組織應確定並提供所需的資源
．實施質量管理並保持其有效性
．符合法規和滿足客戶要求
12. 人力資源：從事影響產品質量工作的人員應受適當的教育、培訓、技能。僱用的人員數量應充足，並與工作量成正比。
所有人員上崗前均應進行體檢，包括眼科檢查，不得有傳染病或傳染病。此後，應定期對其進行醫學檢查，至少每年一次，應保存記錄。
13. 基礎設施：組織應確定、提供和維護實現產品要求符合性所需的基礎設施。
．建築物、工作空間和相關公用設施
．工藝設備（硬體和軟體）
．支持服務（例如運輸或通訊）
．製造商應建立維護活動的書面要求，包括其頻率，當此類活動或缺乏此類活動可能影響產品質量時。應保存此類維護的記錄。
Specification for Quality Management System (QMS)
Manufacture of medical devices shall comply with the requirements, establish, record, implement and maintain quality management and maintain its effectiveness, and the documents shall include:
1. Written statement of quality policy and quality objectives.
2. Quality Manual.
．The scope of the quality management system, including details and justifications for any exclusions or inapplicability or both.
．A documented procedure established for the quality management system, or a reference to it.
．A description of the interaction between the processes of the quality management system. Contains specific information on facilities, personnel and other details.
3. Documenting procedures.
4. Documents required by the manufacturer to ensure the efficient planning, operation and control of its processes.
5. Records of procedures, events or special arrangements.
6. Documentation controls shall be controlled in accordance with the requirements given in Records Controls. Documents should be approved, signed and dated by appropriately authorized personnel. A documented procedure should be established to define the controls required
．Fully review and approve documents prior to publication
．Review and update documents and re-approve documents as necessary
．Ensure changes to documents and current revision status are identified
．Ensure relevant versions of applicable documents are available at the point of use
．Ensure documents remain legible and easily identifiable
．Make sure to identify files from outside and control their distribution
．Prevent accidental use of outdated files
7. Records Control: Records should be retained for at least one year after the expiration of the medical device’s validity period.
8. Management Responsibility: The manufacturer’s top management shall provide a commitment to the development and implementation of a quality management system and maintain its effectiveness through the following means.
．Communicate with staff the importance of meeting customer and statutory and regulatory requirements
．Develop a quality policy
．Make sure to establish quality goals
．Make an administrative review
．Ensure resource availability
9. Quality Policy: The manufacturer’s top management shall ensure the quality policy
．Fit for purpose of manufacturing facility
．Includes a commitment to comply with requirements and maintain the effectiveness of the quality management system
．Provides a framework for establishing and reviewing quality objectives
．Communicate within the manufacturer’s organization
．Review Continued Applicability
10. Quality Objectives: The manufacturer’s top management shall ensure that quality objectives are established at relevant functions and levels within the manufacturing organization, including those required to meet product requirements. Quality objectives should be measurable and consistent with the quality policy.
11. Resource provision: The manufacturing organization shall identify and provide the required resources
．Implement quality management and maintain its effectiveness
．Compliance with regulations and meeting customer requirements
12. Human resources: Personnel engaged in work that affects product quality should receive appropriate education, training, and skills. The number of personnel employed should be sufficient and proportional to the workload. All personnel should undergo a physical examination, including an eye examination, and be free from infectious diseases or communicable diseases before starting work. Thereafter, they should undergo regular medical examinations, at least once a year, and records should be kept.
13. Infrastructure: The organization shall identify, provide and maintain the infrastructure required to achieve compliance with product requirements.
．Buildings, Workspaces and Associated Utilities
．Process equipment (hardware and software)
．Support services (such as shipping or communications)
．Manufacturers shall establish written requirements for maintenance activities, including their frequency, when such activities, or lack thereof, may affect product quality. Records of such maintenance shall be kept.
【參考連結】
HLF-TW-75
HLF-TW-77
HLF-TW-80
外國子公司進口醫療器材後，如果委託印度的經銷商銷售，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 India 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：
無須申請營業許可證。
當發生不良事件，主管機關有權力要求進口商立即啟動召回，以防用戶或患者的健康構成風險。
進口商有責任說明其撤回的原因、發送通知，並且需要提交定期安全性更新報告並建立警戒系統。
No business license is required.
When an adverse event occurs, the competent authority has the power to require the importer to initiate a recall immediately, in case the health of the user or patient poses a risk. Importers are responsible for explaining the reasons for their withdrawal, sending notices, and are required to submit regular security updates and establish a vigilance system.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-85
連絡人：
Email：del4ww@evershinecpa.com
或
印度永輝BPO有限公司
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The Engaging Manager Punit Negi, Indian citizenship
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
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;
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Skype: daleccchen
;
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Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
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