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Health ministry issues draft guidance document on “Essential principles for safety and performance of medical devices”
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Ramesh Shankar, Mumbai
July 26 , 2017
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The Union health ministry has issued the draft guidance document on
“Essential principles for safety and performance of medical devices”.
This
document is prepared under the provisions of Rule 6 of Medical Devices
Rules, 2017 to provide binding guidance for use in the manufacturing of
medical devices which are intended to be sold in India. This document
provides an overview on meeting the essential principles for safety and
performance of medical devices. This document does not dictate how a
manufacturer should prove that their medical device has met the
essential principles laid down in this document, hence providing
flexibility to the manufacturers and catering to technological advances
and changes in the development of new medical devices.
This
guidance document describes fundamental design and manufacturing
requirements, referred to as “Essential Principles for Safety and
Performance” that, when met, indicate a medical device including in
vitro diagnostic (IVD) medical device is safe and performs to its
specification.
There are seven general requirements of safety
and performance that apply to all medical devices including IVD medical
devices as specified in section 4 of this document. There are further
design and manufacturing requirements of safety and performance, some of
which are relevant to each medical device. The design and manufacturing
requirements in this document are grouped in different categories.
They
are chemical, physical and biological properties; infection and
microbial contamination; manufacturing and environmental properties;
devices incorporating a substance considered to be a medicinal product
or drug; devices incorporating materials of biological origin; devices
with a diagnostic or measuring function; devices that incorporate
software and standalone medical device software; active medical devices
and devices connected to them; environmental properties; protection
against radiation; protection against mechanical risks; protection
against the risks posed to the patient by supplied energy or substances;
protection against the risks posed to the patient for devices for
self-testing or self-administration or intended by the manufacturer for
use by lay persons; information supplied by the manufacturer i.e. Label
and Instruction for Use; and performance evaluation including
analytical performance and where appropriate, clinical evaluation.
In
addition to the general essential principles as specified in the
section 4 of this document, above listed additional essential principles
for safety and performance which need to be considered during the
design and manufacturing process are further specified separately for
medical devices other than IVD medical devices; and IVD medical devices.
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