What is an Import License?
An import license is an official permit issued by a regulatory authority that allows an individual or organization to legally bring goods, including medical devices, into India from a foreign country
Who Needs an Import License?
An import license is required by:
- Foreign manufacturers who wish to sell their medical devices in India.
- Authorized Indian agents representing foreign manufacturers.
- Distributors or importers seeking to sell or distribute medical devices commercially.
- Testing laboratories or research institutions importing devices for clinical investigation, testing, or training purposes.
Who Provides the Import License?
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, grants import licenses for medical devices as per the Medical Devices Rules, 2017.
Types of Import Licenses and the Registration Process
The different types of import licenses and their registration processes are as follows:
| Type of Import License | Purpose |
| Import License for Commercial Use (Form MD-15) | Required for commercial import of medical devices intended for sale and distribution. |
| Import Test License (Form MD-17) | Required for importing medical devices for non-commercial purposes like testing, clinical trials, and training. |
| Import License for Novel Devices (Form MD-27) | Required for devices that do not have a predicate (previously approved equivalent) in India. |
| Class A (Non-Sterile/Non-Measuring Devices) Import License | For low-risk medical devices that do not involve sterility or measurement. Required for commercial import of medical devices intended for sale and distribution |
Timelines to get the License
The estimated timelines for obtaining different types of import licenses are:
| Step | Import License for Commercial Use | Import Test License | Import License for Novel Devices | Class A (NonSterile/NonMeasuring Devices) |
| CDSCO Approval & License Issuance | 6-9 Months | 3-6 Months | 9-12 Months | After generating the registration number, it immediately confirms |
| Validity of License | 5 years | 5 years | 5 years | NA |
Wholesale License Requirement
Entities importing medical devices must hold a Wholesale License for Medical Devices, ensuring compliance with storage, distribution, and quality control requirements. The process includes:
- Registering a business with a valid office and storage facility.
- Employing a qualified technical staff member with expertise in handling medical devices.
- Submit an application to the State Licensing Authority (SLA).
- Paying the requisite government fees and undergoing an inspection before license approval.
Role of the Authorized Import Agent
Foreign manufacturers must appoint an Authorized Indian Import Agent, who is responsible for:
- Submitting and managing the import license application.
- Hold a valid Wholesale License (Form 42) issued by the State Licensing Authority (SLA) for Medical Devices.
- Ensuring regulatory compliance and customs clearance.
- Liaising with CDSCO on behalf of the foreign manufacturer.
- Maintain records, report adverse events, and coordinate recalls as necessary
