MDR Labelling Requirements for Medical Devices in India

by Sudhriti M | May 16, 2024 | Medical Device

Medical device labelling is essential for conveying vital information related to the medical device. The labels guide users, thereby play a pivotal role in patient safety. Medical devices are one of the pillars of the healthcare industry. Regulatory guidelines are in...

Regulatory Approval for Software as A Medical Device in India

by Sudhriti M | May 12, 2024 | Medical Device

Medical devices are pivotal for diagnosis, treatment, and patient care. Recently, software is being used to monitor, diagnose, prevent, and even treat diseases. New-age technologies, namely wearables and clinical decision-making tools based on artificial intelligence...

Neutral Code for Medical Device Export

by Sudhriti M | May 8, 2024 | Medical Device

India has gained a reputation for manufacturing high-quality medical devices at competitive prices. The country has supportive regulatory requirements, skilled workforce, and cheap labour offering cost advantages. This has made India a potential global hub for...

Sampling of Medical Devices, Drugs, and Cosmetics

by Sudhriti M | May 7, 2024 | Medical Device, Pharmaceutical

Substandard medical devices and counterfeit drugs can have detrimental impact on patients, thereby paralyze the healthcare system. Recently, Central Drugs Standard Control Organization (CDSCO) issued new guidelines for sampling of medical devices, drugs, and...

Medical Devices Quality Control: A Vital Manufacturing Step

by Sudhriti M | May 6, 2024 | Medical Device

The health and safety of individuals depend on the proper functioning of the medical devices. Medical devices are aimed at improving the lives of their users. However, any malfunction of these devices can pose as a serious health threat for individuals and can be life...