Rigorous testing and evaluation of medical devices and IVDs is necessary to protect the public health. Medical devices and IVDs have a pivotal role in diagnosis and treatment of diseases and various medical conditions. Hence, regulatory officials have to ensure only...
Medical device manufacturers/importers who wish to conduct a clinical investigation in India need to obtain permission from the CLA. The CLA is the Central Licensing Authority (CLA) and functions under the CDSCO. The CDSCO is the Central Drugs Standard Control...
In this blog, we have discussed why pharma companies should pay special attention to downtime, especially unplanned downtime.Additionally, we have provided some tips for reducing downtime in pharma industry. What is downtime? To reduce downtime in pharma industry, it...
In this blog, we have focused on the differences between notified and non-notified medical devices in India. Additionally, we have provided an overview of the different regulatory processes for different categories of medical devices. Furthermore, we have touched upon...
Clean rooms are crucial for manufacturing industries where product quality is easily affected by factors, such as airborne particles. Thus, clean rooms are pivotal in a medical device manufacturing industry. Medical device quality affects the patient outcome. Hence,...