Department of Pharmaceutics, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore-524346, Andhra Pradesh, India
Medical devices, Regulation, Global harmonization, Healthcare industry, Patient safety ,

The healthcare industry is supported by three essential components: drugs, vaccines, and medical devices, each crucial for patient care and treatment. Medical devices encompass a broad spectrum from basic tools like bandages and syringes to advanced technologies integrating bioinformatics, nanotechnology, and artificial intelligence. Recognizing the need for standardized definitions and regulatory frameworks across nations, the World Health Organization (WHO) introduced guidelines in 2003 to define medical devices uniformly. Additionally, the Global Harmonization Task Force (GHTF) was established, comprising international regulatory bodies and stakeholders, aimed at fostering global alignment in medical device regulations despite varying national standards. This study examines and compares the medical device regulations of India, the USA, and the European Union (EU), highlighting key differences and regulatory approaches

14 , 1 , 2024