Medical Device Import License Application
Medical Device Import License : The Government of India (GOI) and State Governments pumping more funds to provide better health services to the people. The presence of highly skilled medical professionals in India with their world class super specialty hospitals helps to grow healthcare systems to next level. However, the manufacturing capacity in India is not sufficient to produce the devices as per the demand. Hence, India mainly depends on the import of medical devices to meet the healthcare needs, which stands at 85 %, as per statistics in 2020. And the medical device market size in India expected to reach $ 50 bn by 2025. As the GOI notifies all the medical devices and IVDs under regulatory, every manufacturer and importer must have a license to sell their products, to maintain their business continuity.
Role of I3CGLOBAL in arranging Medical Device Import License
Helping the clients by making the strategy for market approval based on the product approvals in GHTF countries, product characteristics and risk classification.
Prepares Plant Master File and Device Master File as per the India Medical Device Rules
As the process involving uploading each document against the checklist with comments, we support the entire process of submission in the online system by our expertise and also for the query-responses during the review.
Post Approval Changes
Post approval changes are part of product lifecycle. We supports the client to get prior approvals for the major changes and submits notifications for the minor changes.
Offers support for vigilance procedures as per the CDSCO timelines
“Authorized Agent” means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India;
Any person/firm/enterprise etc. having wholesale license issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices into India.
Plant Master File
Device Master File
As per Part III, Appendix I of India MDR, the plant master file / site master file should contain information related to personnel, premises & facilities, equipment, sanitation, production, storage, quality assurance and documentation, handling of complaints, internal audits and contract activities
As per Part III, Appendix II of India MDR, the device master file should contain Device description, Design and Manufacturing process, Design verification & validation reports, Essential Principles checklist, Risk analysis report, Clinical evaluation, Biocompatibility reports, stability data, sterilization validation reports and PMS data
Based on Risk Medical devices are classified as below..
Class A for Low risk (Hydrophilic Wound Dressing, Latex Medical Examination Glove)
Class B for low moderate risk (Nitrile Gloves, Foetal Doppler System)
Class C for moderate high risk (Negative Pressure Ventilator, Implantable Ligating Clip)
Class D for high risk (Flexible Ultrasound bronchoscope, Intracranial Pressure Monitor Device)
If the medical device total shelf life claim is less than ninety days, it shall not be allowed to be imported by the licensing authority if it has less than forty per cent residual shelf-life on the date of import:
If the medical device total shelf life claim is between ninety days and one year, it shall not be allowed to be imported by the licensing authority if it has less than fifty per cent residual shelf-life on the date of import:
If the medical device total shelf life claim is more than one year, it shall not be allowed to be imported by the licensing authority if it has less than sixty per cent. residual shelf-life on the date of import.
Import license for Class A medical device for one site is 1000 USD, and for each distinct medical device 50 USD
Import license Class B medical device for one site is 2000 USD, and for each distinct medical device 1000 USD
Import license Class C and Class D medical device for one site is 3000 USD, and for each distinct medical device 1500 USD
For Class A and Class B, it will take 4-5 months to get the manufacturing license. For Class C and Class D, it will take 5-6 months. Please consider the timelines for reference purpose only.
A license granted under Form MD-15 shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the authorized agent deposits the license retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licensed medical device after completion of every five years from the date of its issue.
Form MD-14: Application for issue of import license to import medical device
Form MD-15: License to Import Medical Device