The Indian medical device market is dynamic with high potential. In a recent policy update, India has stated it will reduce import duties on medical devices covered by PLI schemes. This update can be attributed to the new free trade agreement (FTA) with the United...
Proper sterilization of medical devices is necessary to reduce chances of infection caused by using these devices. A contaminated medical device will lead to device-induced infection, thereby do more harm than good to the patient. Hence, while manufacturing medical...
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
In this blog, we have discussed common medical device industry quality challenges. Additionally, we have provided some tips on how to overcome them. What are medical device industry quality challenges? Medical device industry quality challenges are technical,...
Clinical chemistry reagents and kits are considered in-vitro diagnostic devices (IVDs) per CDSCO guidelines. They are regulated by the Medical Device Rules, 2017. To manufacture or import clinical chemistry reagents and kits, you need to comply with CDSCO...