Rule 40 of the new medical device rules 2017 defines the provisions about the import of medical devices for testing, evaluation, demonstration or training. According to the new medical device rules, an importer must apply for a test license if a medical device has to be imported for test related purposes.
The application for a test license to import a medical device is filed under form MD-16. The application is made to the Central Licensing Authority along with some pre-required documents. The license pertaining to the application is granted using form MD-17 by the Central Licensing Authority
The process of filing application for a test license is quite complex. We have been helped numerous applicants to help gain a test license for their medical device imports. Our expertise and experience on the topic makes the process amazingly quick and hassle free for the customer.
As already mentioned, there are some documents which are to be submitted with the application form. The first document to be included is a cover letter, which mentions the subject of the intended application and other relevant details pertaining to the test license.
Next is the document which mentions the details of the medical device or devices to be imported. This detailed section just provides a simple overview of the medical device and its supporting components if any.
Furthermore, a brief document containing the description of the device, its functionality, clinical data, process of manufacturing, relevant impact and other pertinent details.
The application also includes a document mentioning the purpose of import. Since the import is being made for test and demonstration purposes, the relevant information needs to be mentioned in it.
Finally, the application needs to provide a document justifying the quantity of the medical device(s) being imported. The applicant needs to mention where the imported devices will be distributed or used and other details concerned with the application of the medical device.
We at CliniExperts help you avoid the hassle of preparing and submitting these documents and undergoing the rigorous application procedure. Our team of experts will ensure that your application is flawless and bears a 100% chance of approval within the least possible time.
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