IPC To Launch Four Unique Tools On Feb 8 To Ensure Safe Medical Devices In The Country

Mumbai, 24 Jan 2019: The Indian Pharmacopoeia Commission (IPC) will launch four unique tools - medical device adverse event (MDAE) reporting form, medical device recall notification form, registered medical device information sharing portal and medical device reference document on February 8, 2019 to create an accountable regulatory ecosystem for medical device industry towards patient safety. 

MDAE reporting form will help generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

The reporting form will help providing inputs on adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number etc.

A registered medical device information sharing portal would serve the purpose of India specific tool which would help IPC to facilitate the baseline study of products available with medical devices companies in India. It would help the Indian drug regulators to verify about faulty medical devices available or banned in other countries also. 

Union health ministry is also planning to create a Registry of High Risk Medical Devices to track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises from the manufacturer’s end.

Medical device reference document will serve as a reference manual for stakeholders such as medical device manufacturers, license holders, regulators, healthcare professionals etc. This document has, inter alia, adopted regulatory requirements and quality management system as specified in the Drugs & Cosmetic Act (D&C Act), 1940 and Rules framed there under. The standards adopted in this document are from the Medical Device (MD) Rules 2017, the Indian Pharmacopoeia (IP), 2018 and other Pharmacopoeia such as British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP) etc and also the standards as prescribed by the Bureau of Indian Standards (BIS). 

This guidance document is intended to provide assistance to medical devices industry, regulators and healthcare professionals on how to comply with governing statutes and regulations for medical devices. 

It is a consolidated reference document made available for manufacturers, traders, distributors, importers, clinical establishments, healthcare professionals and general public about the standards, regulatory and other requirements for medical devices in India. Pharmabiz