Medical Devices - Articles

Medical Devices |
WPC Import License for Wireless Devices in India

WPC import license India is a mandatory regulatory approval required for importing wireless and radio-frequency-enabled devices into the Indian market under the WPC framework. Understanding WPC Compliance in India The Wireless Planning and Coordination Wing (WPC) operates under the Department of Telecommunications in India. It regulates wireless communication equipment and radio frequency usage. Manufacturers and

Medical Devices |
How to Conduct Clinical Performance Evaluation for IVDs in India

Clinical performance evaluation for IVDs ensures that in vitro diagnostic devices introduced into the Indian market provide accurate, reliable, and clinically meaningful results. Manufacturers can demonstrate the diagnostic value of their products while supporting patient safety and effective disease detection by following the regulatory requirements established under Medical Device Rules, 2017, and generating robust clinical

Medical Devices |
How to Get CDSCO Approval for Medical Device Clinical Investigations in India

In India, Medical Devices must meet established safety and quality standards before they can be used in healthcare. The approval process for Medical Device clinical investigation involves a regulated process that includes development, testing, clinical investigation, and review by the Central Licensing Authority. Understanding this process is important for manufacturers and sponsors seeking to introduce

Medical Devices |
Best Practices for Designing Medical Device Clinical Investigations

Best Practices for Designing Medical Device Clinical Investigations What is a clinical investigation of medical devices? Devices, much like pharmaceuticals, must go through extensive testing processes before gaining approval for use on patients. However, Medical Device Clinical Investigations tend to be more manageable and involve fewer stages compared to pharmaceutical trials. Clinical investigation concerning medical

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug

Biologicals |
Consumer Claims |
Diagnostic Kits |
Drug |
Medical Devices |
Effective Site Management in Clinical Research – Points to Consider · Cliniexperts

Effective Site Management in Clinical Research – Points to Consider Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites. Site management in clinical research Efficient site management is essential to ensure that the clinical

Biologicals |
Consumer Claims |
Diagnostic Kits |
Drug |
Medical Devices |
Conducting clinical trial during COVID-19 · Cliniexperts

Conducting Clinical Trial during COVID-19 COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials. The pandemic also paved the way for new

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
Online submission of SAE reports through SUGAM portal · Cliniexperts

Online submission of SAE reports through SUGAM portal The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of

Medical Devices |
Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India · Cliniexperts

Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India Medical devices complement the physician’s or surgeon’s expertise in examination, diagnosis, treatment, or follow-up. Access to medical devices helps a physician come up with the right diagnosis of the patient’s medical condition, or a surgeon to carry out a procedure accurately. These devices enjoy


*All the above fields are mandatory
contact us 2
Enquire now