Clinical Performance Evaluation And Approval Of New Invitro Diagnostics Medical Device In India

In-vitro diagnostic medical devices include those devices that are used for diagnosis of diseases or certain conditions. These devices generate data about a pre-existing condition based upon the evaluation of a sample(blood, urine, etc.), and form an integral and important part of the medical industry. But before a new in vitro medical device can hit the market, it has to abide by certain rules and regulations framed under the Medical Device Regulation India Rules, 2017.

As per the new Medical Device Rules, 2017, if a new in-vitro medical device is to be introduced in the market or imported it needs approval by Central Licensing Authority. It has to go through some testing to ascertain its clinical performance for the required analysis and other parameters. All details about the procedure and the technology involved with the product are needed while submitting an application for the registration of devices.

This process can be streamlined with the help of a in vitro medical device consultant.

The process of clinical performance evaluation and approval of new IVD devices

For the clinical evaluation, an application to grant permission for complete evaluation is to be submitted to the Central Licensing Authority using form MD-22 by the concerned sponsorer along with required fees mentioned in the second schedule. Those institutes, hospitals and organizations that are under the control of the central government or state government are not required to pay such fees for conducting the clinical performance evaluation of new devices.

Information required for submitting in the application:

�-�       A complete description of the device that includes full specification of the raw materials used along with the finished product, information that helps in device recognition, complete instruction for use, labels and the regulatory status of various countries.

�-�       Approval of the required committee.

�-�       Resource and the number of samples to be used for evaluation.

�-�       Complete information about the data utilized in the establishment of stability, repeatability, reproducibility, and specificity of the device.

�-�       The detailed strategy of the evaluation that includes the aim, medical, scientific and the range of evaluation.

�-�       Case report form and undertakings from supervisors.

�-�       The complete list of all involved testing laboratories.

�-�       The total duration of the evaluation.

�-�       If self-testing then all details about the location as well as a number of persons involved.

�-�       An undertaking that the IVD device is in accordance with the requirements of all rules specified by Central Licensing Authority other than all aspects included in the evaluation

�-�       An undertaking that all precautions have been properly taken to defend the patients' health as well as safety.

�-�       A complete report of performance evaluation by a designated laboratory.

Once all relevant information is submitted, it is subjected to proper supervision by the Central Licensing Authority. The authority may also request any other additional information or documents if required. Upon proper evaluation of the documents, resulting in a satisfactory outcome, the CLA can grant permission for conducting the clinical performance evaluation of the proposed ‘new IVD medical device’.

On the other hand, if it is not satisfied with the information and feels that the requirements of the concerned authority have not been compiled, then it may reject the application for clinical evaluation. All the reasons for rejection are well stated as well as recorded in writing, and reverted within a time period of 90 days from the date the application was submitted.

Thus, by now you must have understood the complete process of clinical performance evaluation and approval of new in-vitro diagnostics Medical Device Regulation India