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Panel submits recommendation on aligning GMP requirements for medical devices in lines with ISO standards
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Suja Nair Shirodkar
June 29 , 2015
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In a strategic move that would give a huge thrust to the medical device
sector, the DTAB sub-committee that was set up by the Centre to
deliberate over the possibilities of formulating and aligning the good
manufacturing practice (GMP) guidelines for the sector with the globally
accepted ISO standards, recently submitted its detailed report to the
CDSCO.
It is understood that experts from the government and
the industry had been brainstorming over working towards balancing and
aligning the GMPs for medical devices and in vitro diagnostics with the
ISO 13485 quality management system standard, which is focused on
quality system requirements.
Rajiv Nath, forum coordinator of
AIMED, who was also part of the sub-committee, informed that he is
hopeful that the government will take cognizance of this recommendation
and will act upon it for the best interest of the industry. He further
added that aiming to give reprieve to the sector, the government has
also assured the industry to remove the medical device sector from the
ambit of Schedule M, which is primarily applicable to pharma industry.
It
is important to note that if enacted, this will fall under the Drugs
and Cosmetics Act. Currently, there are only 14 medical devices that are
regulated and recognised as drugs in the country based on the
parameters of GMP requirements as followed for the pharma industry.
Experts from the medical device sector have been demanding the
government to recognise and set separate standards that are in lines
with the globally accepted standards rather than that of GMP, as the
industry dynamics of both the sectors vary greatly.
Nath pointed
out that if the government aligns its GMP requirements for the sector
with that of the internationally accepted standards, it will become
easier for the manufacturers to register their devices in India.
ISO
13485:2003 is an international quality standard specifically designed
for medical device companies. Using it to guide medical device design,
development, and manufacturing is the most common approach for companies
that wish to enter the regulated European, Japanese, Australian and
Canadian markets. Design control, process controls, device traceability,
and customer feedback are just a few of the key areas that ISO 13485
governs.
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