Test License to Import In-vitro Diagnostics in India in India - MD 16 & MD 17
Do you need permission to import in-vitro diagnostic kits to India to demonstrate its performance? CliniExperts’ professionals have the expertise and assist you in securing in-vitro diagnostic kits test license for importer.
Test License to Import In-vitro Diagnostics in India – Overview
The Central Drugs Standard Control Organization (CDSCO) has issued a notice stating that a small number of medical devices might be imported into India. The devices belonging to Class A, Class B, Class C, or Class D may be imported in small quantities to India based on Test License in Form MD-17. These devices may be imported for the purpose of clinical investigations, testing, evaluations, demonstrations, or training.
To obtain a Test license in Form MD-17 and to be able to import the mentioned devices, one must apply for an import license for testing, evaluation, demonstration, or training. The application for the import license should be made to the Central Licensing Authority in Form MD-16, and it must be through an identified online portal of the Ministry of Health and Family Welfare.
Who Can Apply?
The Test License can be applied for by any person who imports in India.
How To Apply?
The Applicant must follow the following process:
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The professionals at CliniExperts have the expertise and can assist the applicant in securing a test license for importing a medical device in Form MD 17 by CDSCO.
Validity
The test license will be valid for three years.
Fee Involved
The Government will charge a fee of 100 USD for the license.Important Documents
For obtaining a Test License in the Form MD-17, the following major documents will be required:
- A brief description of the in vitro diagnostic kit
- The intended use
- Material of construction
- Design – Label and IFU
Timeline to get
MD 17
from Central Drugs Standard Control Organisation
5 to 7
WORKING DAYSEssential Tips
While applying for the license to import medical devices, the applicant must follow the points stated below:
- The quantity to be imported must be clearly stated and justified in the application to be submitted.
- Justification for Quantity to be imported must be prepared adequately and include the batch details, quantity to be utilized, and quantity to be retained.
- The name of the place for testing, evaluation, demonstration, training, or clinical investigation is a requirement and must be finalized and included during submission preparation.
- The name of the place for testing, evaluation, demonstration, training, or clinical investigation is a requirement and must be finalized and included during submission preparation.
Expert Advise
A record of the activities undertaken should be maintained by the test license holder. The records must include the manufacturer's name, quantity import and the date of import.
An invoice or statement showing the medical device's name and quantity should accompany the medical device's consignment.
The Test license should be used only for the purpose it has been obtained.
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Frequently Asked Questions
In a "single” test license application for clinical investigation, testing, evaluation, demonstration, and training, is it possible to mention multiple sites?
Yes
Are the products not intended to be used in humans or animals for the diagnosis of any disease or disorder such as RUO- Research Use Only, Q.C material for accreditation, panel for Q.C testing & product used for food, water, sterility testing used by various industry for Q.C, etc. regulated under MDR, 2017?
No, such products are not regulated under MDR, 2017.
When can the licensee whose license has been cancelled by the Central licensing authority appeal to the authority?
The licensee can appeal within 45 days from the date of the order.
Are the products which are not intended to be used in humans or animals for diagnosis of any disease or disorder, such as microbiological culture media, stains indicators and reagents used for food and water testing, be regulated under MDR, 2017?
No, such products are not regulated under MDR, 2017.
How can a medical device that is required to be taken to a place other than that mentioned in the test license be relocated?
If such a situation arises, the test license holder must inform the Central Licensing Authority in writing before doing so.