In accordance with the latest medical device regulations 2017, an applicant who is planning to import small quantities of medical devices to be used for testing, examination, or analysis, can submit an application in the form MD-16 in the condition that the medical device on the form 17 cannot be utilized for any commercial use. The Central Licensing Authority must submit the application along with certain documents that are required. The medical device license that is required for this application will be granted on the form MD-17 from the Central Licensing Authority.

CliniExperts assists its clients in creating the dossier required for submitting a test license application for the medical device. As we mentioned previously, the required documents should include a cover letter clearly detailing the specifics of the product, such as the name, classification, and the reasons for the quantity that is of the product that will be imported. Additionally, a test protocol/approved clinical investigation plan/testing method used to test the medical instrument, quality certificates such as QMS or Specimen Label, and an undertaking that states that the device to be imported will not be used for commercial purposes.

Permission To Medical Device Import License For Test and Clinical Investigation

New Medical Device Rules 2017 have classified the categories of medical devices into four broad categories based upon the risk classifications for the particular products. To get permission for a test license to import a medical device, it is necessary to understand the classification so that we know the proper fee structure to grant approval. The following table suggests the application form, approval form, and fee structure will be based on medical products' risk classification.

Medical Device Test License For Importer Application Form

Form MD 16 - Application for Test License to Import Medical Devices for the Purposes of Clinical Investigations or Evaluation or Demonstration or Training

Form MD 17 – Approval of License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

Government Fee For Test License For Medical Device Import

The predefined fee for getting a test license in Form MD 17 to import medical devices is $100 / per product.

Required Documents For License Approval To Import Medical Device Test

The applicant must upload all the necessary documents and the required fee on the online Sugam portal along with form MD 16. The necessary documents for Licence to Import Medical Devices for Clinical Investigations or Test or Evaluation or Demonstration or Training –

1. Applicant’s name, address, contact number, email id, etc.

2. Name and address of medical device manufacturer

3. Proposed clinical investigation site name and address

4. Medical device(s) details that are going to be imported

5. Medical device brief description 

6. The motive for medical device import

7. Justification for the medical device quantity you want to import

8. An undertaking that states that all necessary facilities, instruments, equipment, and personnel are in place to test or evaluate a medical device(s).

9. An undertaking that the specific medical device is proposed to be imported will be used only for the specific purposes as indicated by number 7 . It will not be utilized for any commercial purposes. 

10. Receipt, challan, and transaction id of the paid fee. 

11. Declaration

Timeline for Medical Device Import Test License Approval

The preparation of documents for regulatory compliance is an extremely time-consuming and laborious process. If you are an importer or a foreign manufacturer, you're immersed in a variety of aspects of the business prior to launching the medical product in India. If an error occurs, it could cause a complete delay in the process of addressing regulatory issues and business plan overheads, financial planning problems, and disruptions in the supply chain. The predefined timeline to import medical device test license approval is 30 working days. 

Validity For Medical Device Test License For Importer

A medical device test license for the importer is valid for three years unless it is suspended or cancelled earlier. 

Do you need permission to import medical devices into India to show its performance? CliniExperts professionals are experts and will assist you in obtaining an import permit for medical devices to conduct clinical investigations and evaluation using the form MD 17 issued by CDSCO. It is possible to import a tiny quantity of Class A / Class B / Class C / Class D medical devices into India. The test license may be used to test or evaluate, demonstrate, or even train for medical devices. Central Drugs Standard Control Organization (CDSCO) is the authority for regulation in India that issues the test license for medical devices.

CliniExperts supports you with the easy preparation and submission of these documents and going through the lengthy application process. Our experts will make sure that the submission is perfect and has the highest likelihood of being approved in the shortest time possible.