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    Medical Device Test License

    When there is a new technology implemented, or new material used for the device manufacturing, or mentions any new indication for use, the manufacturer has to confirm the safety and performance of the device. For this purpose, the manufacturer needs to manufacture small quantity of devices for the evaluation.

     

    When you want to import a medical device to India and not aware its characteristics, or you want to demonstrate its performance, or provide training to healthcare professionals, then you need a test license for import a small quantity of devices from its origin, as per the requirements.

     

    We offer our expertise to secure a test license for a manufacturer or importer based on the organization’s requirements.

    Type of Test License and Forms

    Test License 1

    When there is a requirement of small quantity of Class A or Class B or Class C or Class D of medical devices, for the purpose of clinical investigations, test, evaluation, examination, demonstration or training, we can apply for a test license to manufacture.

     

    Form MD-12:

     

    Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training

     

    Form MD-13:

     

    Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation

    or Demonstration or Training

    Test License 2

    If any medical device or in vitro diagnostic medical device required to import, for the purpose of clinical investigations or test or evaluation or demonstration or training, we can apply for a test license to import.

     

     

    Form MD-16:

     

    Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or

    Evaluation or Demonstration or Training

     

    Form MD-17:

     

    Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

    Buy Risk Analysis Procedure & Templates

    Very useful for small and medium size medical device manufactures