Health Ministry publishes draft on standards for medical devices, Invites Comments

Guidance Document is now available to seek stakeholder’s comments till 01/09/2018 (30 calendar days).

New Delhi: The Ministry of Health and Family Welfare has published a draft on the standard for medical devices covering a whole range of medical devices ranging from simple items to very complicated items such as ice-bags, tongue depressors, cardiac-pacemakers and proton-therapy devices.

The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) released Draft Guidance Document for Medical Devices as a unique document which covers all the relevant information related to Medical Device under one umbrella.

This document is aimed at an essential reference manual for medical devices industries, policy makers and healthcare professionals for delivering their services by focusing on patient’s wellbeing

The Hindu reports that the guidance document describes fundamental design and manufacturing requirements for up to 594 medical devices, referred to as “Essential Principles for Safety and Performance” that will indicate a medical device is safe and performs to its specification.

The devices are classified into categories A, B, C, D where category A being the most low-risk device, B is for low-moderate high-risk devices, C is for moderate high-risk devices and D is for high-risk devices. These categories will elaborate on the management of quality.

It included the products like ablation devices, catheters, bone cement, cardiac stents, contraceptives like tubal and fallopian rings, male and female condoms, disinfectants, disposable hypodermic needles, heart valves, internal prosthetic replacements like penile, dental, vaginal, breast, retinal, cochlear implants and etc.

The draft states that the design and manufacturing requirements are grouped in many categories including those that pose a risk of infection, devices incorporating materials of biological origin and so on.

The medical devices incorporating non-viable tissues, cells and substances of animal origin, the animals should have been subjected to veterinary controls and surveillance and the manufacturer is required to retain information on the geographical origin of the animals.

In addition to the newly introduced Medical Devices Rules earlier in January, the draft also refers to the British, Japanese, European as well as Bureau of Indian Standards while framing standards.

RK Vats, Additional Secretary, Union Health Ministry told the Hindu, “Upon proper implementation of the guidelines and standards so given in this document, this will help improve the quality of medical devices and their proper management so as to build confidence among the population and minimize patient risk.”

Attached is the document below

http://ipc.gov.in/images/mvpi/Guidance_Document.pdf

Kindly provide your suggestions/comments on Guidance Document in a format attached herewith till 01/09/2018 to mvpi.ipcindia@gmail.com