Industry Wants ICMED Certification
Mandatory For All Medical Devices Marketed In India
Experts have urged the Centre to make Indian Certification of
Medical Devices Scheme (ICMED), country’s first indigenously developed quality
assurance system for medical devices mandatory for all medical devices marketed
in the country. This was proposed in recently concluded meeting called to draft
(separate) rules for medical devices with the top government officials with
special focus on drafting regulatory framework for granting manufacturing
licenses for medical devices.
The meeting stressed upon the need for registration of low
risk and moderate risk devices on basis of 3rd Party (CAB) certification and
grant of manufacturing license to high risk device manufacturers and importers
on basis of defined criteria and inspection. This according to sources will be
done by CDSCO medical devices officers with a predefined competency or through
3rd party certification bodies.
Association of Indian Medical Devices Industry (AIMED)
strongly advocated that ICMED certification should be made mandatory as the
scheme will be able to fill big regulatory vacuum in quality certification space
for medical devices in the country and will enhance the competitiveness and
profitability of Indian medical device industry. Currently, there is no
India-specific official quality assurance system, due to which Indian medical
device manufacturers encountered loss of competitiveness to foreign companies
while consumers ended up paying extra premium with no concomitant benefits,
ICMED also fills a big regulatory void.
Launched in March, ICMED has two certification options, ICMED
9000 certification (an ISO 9001 plus additional requirements) for low risk
medical devices and ICMED 13485 (An ISO 13485 plus additional requirements) for
medium and higher risk devices. A third level, to additionally prescribe medical
device specifications developed by health ministries NHSRC is still under
development and would be launched later this year.
“Why not make ICMED certification mandatory, as it is aimed
at enhancing patient safety, provide enhanced consumer protection along with
much needed product credentials to manufacturers for instilling confidence among
buyers and users. This Scheme is intended to significantly eliminate trading of
sub-standard products or devices of doubtful origins, a widespread and injurious
phenomenon in the Indian market. Most importantly, it will bring down the
substantial time and cost-run to obtain globally accepted quality certification
for Indian companies, thereby ensuring substantial savings, enhanced
credibility,” stressed Rajiv Nath, forum coordinator, AIMED and chairman,
technical committee, QCI-AIMED.
ICMED is the first home developed international class
certification scheme for the medical devices in the country. It is a joint
initiative of AIMED, Quality Council of India (QCI) and the National
Accreditation Board for Certification Bodies (NABCB).
India And Japan To Seek Regulatory
Collaboration For Medical Products
The Japan has extended support to Government of India for
Indian regulators’ skill enhancement through its Asia Training Centre.
India and Japan are looking to accelerate collaboration for
medical products through increased collaboration between the regulators of the
two countries. Against this background, the first ever joint symposium between
India and Japan to facilitate regulatory collaboration for medical products was
organised by FICCI from May 18-19, 2016 in New Delhi.
As India is scaling up its healthcare systems and in parallel
streamlining the pharmaceutical and medical devices regulatory guidelines, it is
envisaged that harmonisation of regulatory frameworks will benefit trade
exchange & technology exchange for larger good. Japan is the third largest
medical devices manufacturer and consumer in the world. It is a pioneer for
development of several pharmaceutical and medical devices.
Japan and India are strong cultural and trade partners, with
Japan being the fourth largest FDI contributor to India. Under the agreement
held in 2015 between PM Narendra Modi and Japanese PM Shinzo Abe, FDIs from
Japan are likely to be doubled by 2019.
During the two day symposium, participants from both
countries agreed to collaborate more comprehensively in future. The Japanese
side has extended support to Government of India for Indian regulators’ skill
enhancement through its Asia Training Centre.
This is a great start. We have achieved much needed momentum
for our regulators to meet and collaborate. From this point onwards, we
collectively commit ourselves to greater partnership and bilateral
relationship”, said Probir Das, chairman, FICCI Medical Devices Forum.