21 FAQs on Indian Regulations for Medical Devices

by Sudhriti M | May 17, 2024 | Medical Device

India is a potential global hub for medical devices. Increase in awareness, longevity, and supportive government policies are some of the factors fuelling the demand for medical devices. Hence, entities are trying to tap into the potential of the Indian medical device...

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...