Certification Of Medical Devices Scheme (ICMED)
- country’s first indigenous quality assurance system
for medical devices was launched in New Delhi.
“ICMED”- a first home
developed international class certification scheme for
medical devices in the country is the joint initiative of
Association of Indian Medical Device Industry (AIMED) and
Quality Council of India (QCI) and the National
Accreditation Board for Certification Bodies (NABCB).
“ICMED” is aimed at enhancing patient safety, to provide
enhanced consumer protection along with product
credentials to manufacturers for instilling confidence
among buyers and users.
For manufacturers, it aims to
bring down the substantial time and cost-run to obtain
globally accepted quality certification and eliminate the
malpractices of sub-standard or fraudulent certification
or quality audits.“The scheme fills a big regulatory
vacuum in quality certification space for medical devices
in the country & will enhance the competitiveness and
profitability of Indian medical device industry,” said Dr.
V. K. Subburaj, Secretary, Dept. of Pharma, GoI.
“The Scheme is a significant
milestone for both consumers as well as manufacturers as
it brings quality, accountability and competitiveness and
in due course will also bring respect to Brand India for
those carrying this certificate,” said Mr. Rajiv Nath,
Forum Coordinator, AIMED & Chairman, Technical Committee,
QCI AIMED Voluntary Initiative on Medical Devices.
The Certification Scheme being
launched has presently two options for certification, one
‘ICMED 9000 Certification (an ISO 9001 plus additional
requirements)’ for low risk medical devices and other
‘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, Ministry of Health and Family Welfare
is still under development and would be launched later.
According to Dr. M. K. Bhan,
former Secretary to the Govt. of India, Dept. of Biotech,
Ministry of Science & Tech., for a country like India, the
twin challenge is to ensure availability of quality
healthcare products at reasonable cost In this direction,
the launch of “ICMED” is a significant collaborative
initiative & will ensure realization of these objectives”.
“QCI is happy to lend a helping hand to the medical device
industry to showcase its strength in terms of meeting the
highest international standards. It would contribute to
the success of govt’s flagship Make in India program,
”said Mr. Adil Zainul, Chairman, QCI.
“NABCB is accrediting
certification and inspection bodies and its accreditation
programmes are internationally equivalent placing it on
par with European and American accreditation bodies. This
equivalence would help facilitate acceptance of “ICMED”
certification in overseas market,”said Mr.Anil Jauhri,
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 would accredit these certifying bodies as per
applicable international standards. The certification
scheme is open to both indigenous and foreign
“ICMED” is the fructification
of a MoU signed between QCI and AIMED on 30 Oct 2014 to
fill the regulatory vacuum in quality certification space
for medical devices in the country. The scheme has been
developed involving various stakeholders with a Steering
Committee chaired by Dr. M.K. Bhan, supported by a
Technical Committee and a Certification Committee
constituted for this purpose. More than twenty govt. and
non-govt. organizations participated in various
Amendment Of Drug Rule
76 To Delink Medical Devices From Pharmaceutical
And Revision Of Schedule MIII And Its Alignment With
IS/ISO 13485 Notified
In the notification dated
March 29, 2016, Ministry of Health and Family Welfare
(Dept. of Health and Family Welfare) has issued draft
rules to amend the Drugs and Cosmetics Rules, 1945 for
which objections and suggestions are invited.
The words Schedule M and
Schedule M III are replaced by Schedule M relating to
pharmaceuticals products and Schedule M-III relating to
Medical Devices and In-Vitro Diagnostics.
The Highlights Of The Draft
The provisions of this
schedule shall be applicable to manufacturers of finished
Devices, in-vitro Diagnostics, mechanical contraceptives
(condoms, intrauterine devices, tubal rings), surgical
dressings, surgical bandages, surgical staplers and
ligatures, blood and blood components (collection bags,
intended for human or animal use and manufactured in
Finished Devices means any
Device or accessory to any Device that is suitable for use
or capable of functioning, whether or not it is packaged,
labeled or sterilized.
In-vitro Diagnostic means
in-vitro diagnostics referred in this Schedule including
diagnostic kits and reagents that fall under sub-clause (i)
of clause (b) of section 3 of Drugs and Cosmetics Act,
Medical Device referred in
this Schedule means Devices that are notified under clause
(iv) of sub-section (b) of section 3 of Drugs and
Cosmetics Act, 1940.
Regarding the work environment
condition the Schedule has specified requirements for the
following products: Cardiac Stents/ Drug Eluting Stent,
Heart Valve, Intra Ocular Lenses, Bone Cements, Internal
Prosthetic Replacement, Orthopedic Implants and Catheters/
I V Cannulae/ Scalp Vein Set.
The detailed report is available at (
Medical Devices With BIS
Certification Is In Vogue With The “Make-In-India” Policy:
DGAFMS, Ministry Of Defence
BIS 13485 certification is
accepted equivalent to US FDA and CE for QMS Compliance.
Formal recognition by Defence,
not to keep USA FDA as exclusionary.
General-acquisition, Ministry of Defence has intimated
that for technologically sensitive products or devices on
which the life of the patient depends, it is the endeavor
to procure the best product available globally which
satisfy stringent norms for the device quality and patient
safety. In the large interest of the patient and to
administer or provide the best available treatment
modalities, the equipment are required to be either USFDA
or European CE or BIS certified. The item may be certified
by any of the above certification agencies and not
mandatorily by USFDA or European CE.
The qualitative requirements
are prepared so as to generate maximum competition among
the vendors to avoid single tender situation.