India–UK FTA, effective July 15, 2026, introduces mutual regulatory recognition for medical devices. Additionally, it removes tariffs on Indian exports, such as surgical instruments, diagnostic equipment, ECG machines, and X-ray systems. This means Indian...
CDSCO is the apex regulatory body for cosmetics in India. Thus, all cosmetics and their variants will have to be registered with the CDSCO to be launched in India. Under CDSCO, cosmetic variants are defined as differences in shade, fragrance, flavour, or pack size of...
In vitro diagnostics (IVDs) are devices used to perform tests outside the human body on samples, such as blood, urine, or tissue. They are used to detect diseases, monitor health, and guide treatment decisions. They play a crucial role in healthcare by enabling early...
ISO 13485 certification is the internationally recognized accreditation for medical device companies. It demonstrates compliance with a robust Quality Management System (QMS) tailored to patient safety, regulatory requirements, and risk management. The certification...
The US FDA accepts MDSAP audits in lieu of routine inspections. Hence, a single MDSAP audit can demonstrate compliance with both ISO 13485:2016 and FDA’s Quality System Regulation (21 CFR Part 820). For manufacturers, this reduces the burden of undergoing separate FDA...