Materiovigilance: Current status in India analogous to its global status

Abstract

Introduction: Medical devices are boon to the healthcare system and are available in the market since long ago. More than 500,000 different types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and safety of these medical devices is essential.

Objectives: This review article discusses the classification and regulation of medical devices in India and the world with framework of adverse event reporting system for medical devices in India.

Methods: To address the aforesaid issue International Medical Device Regulators Forum (IMDF) was established in 2011 was established at international Level. In India, 4 years later in 2015, Materiovoigilance Program of india (MvPI) was introduced with the prime aim of improving the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood of reoccurrence of an adverse event associated with the use of medical devices.

Results: At present, there are 50 Medical Device Adverse Event Monitoring Centres (MDMCs) in India. Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices eg: USFDA in USA, TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc.

Conclusions: In India, the provisions of regulation of safety, quality and performance of medical devices are laid down in the Drugs and Cosmetics Act, 1940 and rules 1945.