In order to serve as a ready reckoner for stakeholders of medical device and pharmaceutical industry, the Indian Pharmacopoeia Commission (IPC) under the union health ministry will soon introduce first reference document on medical devices in the country to ensure patient safety. The draft reference document on medical devices which is currently being reviewed will serve the statutory, regulatory and technical information requirements of the medical device and pharma industry.
This is a first ever document to be introduced in the country following the launch of new Medical Devices Rules (MDR) 2017 which came into effect from January 1, 2018 to ensure safety of medical devices.
According to a senior IPC official, “The draft was made available to the stakeholders for their suggestions and recommendations. Till now, we have received an overwhelming response with 153 suggestions for additions, deletions and further improvement.”
In order to review the suggestions, a meeting was organized and chaired by Dr G N Singh, secretary-cum-scientific director, IPC. Experts from Central Drugs Standard Control Organisation (CDSCO), Indian Institute of Technology (IIT) and medical device representatives from various associations participated in the review process. IPC is in the process of incorporating the suggestions and release final document in due course of time, the IPC official added.
Drafted as per new MDR 2017, the document aims to serve as a ready reference for all the stakeholders such as medical devices, pharmaceutical industries, suppliers and distributors
This document will also be beneficial to the hospitals, research and academic institutions to have first hand information. The document covers definition, notified devices, risk based classification, testing and accreditation, Quality Management System (QMS), Standards and post marketing surveillance (PMS).
The new MD Rules, 2017 are set out to regulate all aspects and activities pertaining to medical devices, namely manufacture of medical devices for sale or distribution, import of medical devices, labeling of medical devices, conducting clinical investigation of medical devices, import and manufacture of medical devices which do not have a predicate device, registration of laboratories for carrying out test or evaluation of medical devices, sale of medical devices, recall of medical devices and export of medical devices.