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Now, MRP Must On Medical Devices
Union Minister for Consumer Affairs Ram Vilas Paswan today
said that medical devices have been brought under the ambit of Packaged
Commodities Rules.
This will make it obligatory for the display of retail sale
of prices (MRPs) on the devices with regard to their sale. This will ensure
uniformity in the quality of devices, their brand and prices. This had been a
long-standing demand of consumers. He said that a committee has been instituted
in the Consumer Affairs Ministry to look into complaints with regard to rates
following the roll-out of GST.
He said the ministry is keeping a close watch on the prices
of commodities that have undergone a change in the GST regime.
“On account of implementation of GST from July 1, there may
be instances where the MRP of a pre-packaged commodity is required to be
changed,” Paswan said.
In this context, the ministry has allowed manufacturers or
packers or importers of pre-packaged commodities to declare the changed MRPs on
the unsold stock prior to July 1, after inclusion of the increased amount of tax
due to GST, if any, in addition to the existing MRP for three months July 1 to
September 30.
“The declaration of the changed MRP shall be made by way of
stamping or putting sticker or online printing,” Paswan added.
http://www.tribuneindia.com/news/business/now-mrp-must-onmedical-devices/433335.html
Health Ministry Issues Draft Guidance
Document On “Essential Principles For Safety And Performance Of Medical Devices”
The Union health ministry has issued the draft guidance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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