India Medical Device Regulation QA
Email: bom4ww@evershinecpa.com
A-16, 1st Floor, Aruna Asaf Ali Marg, Qutub Institutional Area, New Delhi, 110067, India
Manager Punit Singh Negi , speak in Indian and English.
Skype: cspunitnegi
HLF-TW-10
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：
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
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
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：
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
假如需要辦理指派印度公司擔任營業代理人，請問印度有專業服務公司可以協助？
Evershine RD：
Narula Udyog
Scienmedisys
http://www.physioscientific.com/
HLF-TW-40
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：
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
請問在印度有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
Regdesk
Arogya
HLF-TW-50
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：
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
請問在印度有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
Regdesk
Arogya
HLF-TW-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
印度醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
SGS
TÜV
Microbac
HLF-TW-77
請問在印度有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
TÜV
AiMeD
HLF-TW-80
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：
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
請問在印度有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
HG
Arogya Legal
ECA
https://www.equicorplegal.com/
Contact Us
Email: bom4ww@evershinecpa.com
A-16, 1st Floor, Aruna Asaf Ali Marg, Qutub Institutional Area, New Delhi, 110067, India
Manager Punit Singh Negi , speak in Indian and English.
Skype: cspunitnegi
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4bom@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
Linkedin address:Dale Chen
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