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Gujarat FDCA Starts
Issuing RCs To Medical Devices Manufacturers As Part Of
Transitioning To New MD Regime
The Gujarat Food and Drug
Control Administration (FDCA) has started issuing
Registration Certificate (RC) (MD-42) to medical device
manufacturers in the state as part of the transitioning to
new medical device regime in a smooth way.
It recently issued RCs to 30
members of the Ophthalmic Association, Ahmedabad as part
of the workshop organized on new Medical Device (MD)
Rules- 2017. The new (MD) Rules 2017 is still in
transition period and will take time of another two years
till October 1, 2023 to be implemented completely.
As per new Medical Device
(MD) Rules, 2017, RC is required as Non-Notified Class A
and B medical devices must require an Import License by
October 1, 2022 while Non-Notified Class C and D medical
devices must have one by October 1, 2023. Some products,
called notified medical devices, required a more extensive
registration requiring a device master file, called an
import license.
As per a Drugs Controller
General of India (DCGI) notification dated September 30,
2022, it is required to have RC (MD-42) for vendors
engaged in the medical device sector.
The Central government vide
Gazette notification GSR 754(E) dated September 30, 2022,
has notified that to sell, stock, exhibit or offer for
sale or distribute medical device including in vitro
diagnostic (IVD) medical device, a Registration
Certificate in form MD 42 is mandatory if the firm is not
holding license under sub Rule (1) of Rule 87 of Medical
Devices Rules 2017.
As of today there are 615 own
medical devices (in Form – MD -5) licensees in Gujarat, 55
medical devices loan licensees (in Form – MD -6) with a
total number of 670 licensees in the state. Sales licenses
in Gujarat state in (in Form MD -42) are 114 as of today.
“The Gujarat FDCA in
collaboration with Ahmedabad Optical Association (AoA) did
on-the-spot registration for vendors engaged in the
medical device sector in the Ophthalmic segment in
Ahmedabad and surrounding districts. RC (MD-42) was
awarded to them at Ahmedabad Management Association (AMA)
office as part of Good Governance Week. The state of
Gujarat is experiencing exponential growth in the field of
pharmaceutical industry and medical devices in the country
due to Atmanirbhar Bharat, Make in India campaign,” said
Dr HG Koshia, Gujarat FDCA Commissioner.
There is no established
regulatory regime today. It will take another two years to
get implemented based on government notifications.
Government has notified 18 months for voluntary
registration of medical devices with effect from April 1,
2020 following which Class A and Class B medical devices
will get time for the licensing process for 12 months and
another 12 months for Class C and Class D. This entire
process will take time until October 2023 for the new
medical device regulations to get implemented.
According to experts until
the time regulations are not in place which will most
likely come into being by October 2023, the manufacturers
will have to secure registration certificates.
Y G Darji, Assistant
Commissioner, Ahmedabad Division (Division -2), A A Raddia,
Assistant Commissioner, Ahmedabad Division-1, V D Dobariya,
Assistant Commissioner, Ahmedabad Rural, M P Gadhvi
(Assistant Commissioner, Medical Devices, Gandhinagar),
Yogeshbhai Parikh (Vice President, Gujarat Chamber of
Commerce and Industry) and Nareshbhai Choksi (President,
Ahmedabad Optical Association) and their office bearers
participated during the workshop.
Experts have also revealed
that a large number of certificates of certification for
quality management systems (QMS) as per international
standard, ISO 13485, in medical devices are unauthentic or
fake.
http://www.pharmabiz.com/NewsDetails.aspx?aid=155601&sid
=1 ; January 6, 2023
Medical Devices Industry
Seeks Clarity On Misbranded And Adulterated Medical
Devices In New Drugs Bill
The medical device industry
has sought clarity from the Centre on misbranded and
adulterated medical devices with reference to Draft New
Drugs, Medical Devices and Cosmetics Bill, 2022.
According to industry
experts, the draft bill stipulates that medical devices
shall be deemed to be misbranded if it “containing colours
not expressly permitted in the license or permission
issued under this Chapter” with reference to Section 127
(d) misbranded medical devices.
Speaking on the sidelines of
the recently concluded IPC at Nagpur, Rajiv Nath, Forum
Coordinator, Association of Indian Medical Device Industry
(AiMeD) said, “In this regard, we would like to clarify
that in medical devices colours are used not only for
brand and logo but also for the identification of
size/gauge of medical devices. The colour are as per the
relevant standard (e.g. IS/ISO 6009 for colour coding of
devices).
As per the draft bill, a
medical device shall be deemed to be adulterated, “if it
consists in whole or in part, of rusted or corroded or
filthy or putrid or decomposed substance” with reference
to Section 128 (a) adulterated medical device.
“In this regard, we would
like to submit that the above definition of adulterated
medical device does not fit well with the construction and
nature of most of the medical devices. These devices are
engineered products made under a tolerance where the
storage, usage conditions and usage skills need to be
considered before putting a criminal insinuation on a
manufacturer,” an industry official clarified.
http://www.pharmabiz.com/NewsDetails.aspx?aid=155942&sid
=1; January 25, 2023
NCC-MvPI Identifies 119
New MDAEM Centres In Various States To Report Medical
Device Adverse Events
The Ghaziabad-based Indian
Pharmacopoeia Commission (IPC) which is the national
co-coordinating centre (NCC) for the Materiovigilance
Programme of India (MvPI) has identified 119 new Medical
Device Adverse Event Monitoring (MDAEM) centres in various
states to report medical device adverse events.
Speaking on the sidelines of
the recently concluded IPC at Nagpur, a senior IPC
official said that MDAEM centres have been set up to
analyse serious adverse events (SAEs) exclusively as part
of MvPI.
MvPI is meant to enable
safety data collection in a systematic manner so that
regulatory decisions and recommendations on safe use of
medical devices for India could be based on data generated
in India.
The MvPI, being coordinated
by the IPC at Ghaziabad, was launched in 2015. IPC
functions as the NCC and Sree Chitra Tirunal Institute for
Medical Sciences and Technology (SCTIMST) in
Thiruvananthapuram acts as the collaborating centre.
Technical support is being provided by the National Health
Systems Resource Centre (NHSRC) in New Delhi.
http://www.pharmabiz.com/NewsDetails.aspx?aid=155961&sid
=1; January 27, 2023
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