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HMD Becomes First ICMED Certified Medical
Device Company In India
Setting a benchmark in the industry, the Hindustan Syringes &
Medical Devices (HMD) became the first Indian Certification of Medical Devices
Scheme (ICMED) certified medical device company in India. With this
accreditation the company has achieved a significant milestone as it brings
quality, accountability and competitiveness into the system.
ICMED is the country’s first indigenous quality assurance
system for medical devices that was launched recently to fill in a big
regulatory vacuum in quality certification space for medical devices in India.
This scheme ushers new standards for device; patient safety for consumers and
the convenience of obtaining international class quality certification within
the country for manufacturers, thereby ensuring significant savings and
enhancing competitiveness.
Keen to enhance the competitiveness and profitability of
Indian medical device industry, this initiative was jointly undertaken by
Association of Indian Medical Device Industry (AIMED), Quality Council of India
(QCI) and the National Accreditation Board for Certification Bodies (NABCB).
This Scheme is intended to significantly eliminate trading of substandard
products or devices of doubtful origins, a widespread and injurious phenomenon
in the Indian market.
For manufacturers, it aims to bring down the substantial time
and cost-run to obtain globally accepted quality certification for Indian
companies and eliminate the malpractices of sub-standard or fraudulent
certification or quality audits, thereby ensuring substantial savings, enhanced
credibility and increased competitiveness, informed Rajiv Nath, joint managing
director, HMD. He further added that in due course this scheme will also bring
respect to brand India for those carrying this certificate.
The certification scheme has presently two options for
certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional
requirements)’ for low risk medical devices and other being ‘ICMED 13485 (An ISO
13485 Plus additional requirements)’ for medium and higher risk devices. A third
level, which would additionally prescribe medical device specifications
developed by NHSRC of health ministry is still under development and would be
launched later this year.
“The manufacturers would need to approach any one of the
certification bodies approved by QCI under the scheme for obtaining
certification. The certification bodies shall be under the oversight of NABCB,
which as the national accreditation body, would accredit these certifying bodies
as per applicable international standards. The certification scheme is open to
both indigenous and foreign manufacturers though Indian manufacturers would be
expected to queue up initially. Since it’s a voluntary certification scheme its
initial success would ride on procurement agencies demanding for this as a
qualifying criteria,” said Nath who is also the forum coordinator of AIMED.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=96174&sid=1)
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