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D&C Rules On Labeling Norms, Shelf Life Of Medical Devices
The Centre is
expected to further streamline the medical devices sector by suitably amending
the norms on labeling, qualification for supervision of manufacturing of
devices, quality standards and shelf life under the Drugs and Cosmetic Rules.
Though a Bill to
amend the Drugs & Cosmetics Act by including a whole chapter on the medical
devices sector is under the scrutiny of the Parliamentary panel after tabling it
in the Rajya Sabha, the government has already drafted some amendments to the D
&C Rules regarding labeling and quality standards.
Provisions of Rule 76
will be changed to specify the qualification of those supervising the
manufacturing of medical devices. A graduate in pharmacy or engineering in
appropriate branch with 18 months experience in manufacturing or testing of
devices, a graduate in physics, chemistry or microbiology with three years
experience, and a diploma holder in pharmacy/engineering with four years service
will need to supervise the manufacturing of devices.
According to the
draft rules, the shelf life of the medical devices shall not exceed 60 months
from the date of manufacturing.
According to the
draft under Schedule R-1, “The medical devices shall conform to the Indian
standards laid down from time to time by the Bureau of Indian Standards (BIS).
If there are no BIS standards then, it shall conform to the international
standards like International Organisation for Standardisation (ISO), or other
International Pharmacopoeia Standards and such other standards as may be
prescribed. In case national or international standards are not available, the
device shall conform to the manufacturer’s validated standards”.
(Ref : Chronicle
Pharmabiz: Nov 21, 2013)
New
Torquers For Guide Wires
 Qosina
is pleased to announce the addition of three new Torquers, #97344 for use with
guide wires 0.008 inch - 0.018 inch (0.20 mm -0.46 mm, 0.6 FR - 1.4 FR) and
#97345 or #97346 which fit 0.014 inch - 0.038 inch (0.36 mm - 0.96 mm, 1.1 FR -
3 FR). Torquer #97346 has a narrow profile design which is smaller and lighter
than the other two. The ridged, slip resistant grip of all three improves
handling and maneuverability for precise control during use. They are made with
a Polybutylene Terepthalate body and cap, and a Polycarbonate collet which helps
prevent the stripping of a coated guide wire. Qosina also offers guide wire
accessories including a variety of torquers in many styles ranging from 0.008
inch - 0.055 inch (0.20 mm -1.4 mm, 0.6 FR - 4.3 FR).
Contact :
David Walker, QOSINA,
150-Q Executive Drive, Edgewood,
NY 11717
P: +1 (631) 242-3000,
F: +1 (631) 242-3230,
E: dwalker@qosina.com
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