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Health
Ministry To Relax ISO Compliance Norms For Medical Devices
To Register With CDSCO
In a relief to the medical
devices industry, especially the micro, Small and Medium
Scale Enterprises (MSME), the Union ministry of health and
family welfare is planning to relax the norms related to
registration of medical devices with the regulator by
allowing more time to comply with the ISO 13485
certification, which is a prerequisite to get the
registration.
This comes at a time when the
majority of the medical devices manufacturers complained
that they could not get the registration done within
September 30, when the timeline for voluntary registration
ended, due to difficulties in getting the ISO
certification amidst Covid-19 pandemic and related
disruption.
A draft amendment rules
notified by the Ministry, proposed insertion of a proviso
and explanation, under the Rule 19 B, in subrule (2), in
item (iii), where in the Rules, it is stated that the
certificate of compliance in respect to ISO 13485 standard
accredited by National Accreditation Board for
Certification Bodies or International Accreditation Forum
in respect of the medical devices, has to be uploaded for
registration on the online system for medical devices,
established by the Central Drugs Standard Control
Organisation (CDSCO).
The draft amendment rule adds
a provision that in case the applicant submits, on or
before November 30, 2021, an undertaking that applicant
shall obtain the ISO 13485 certificate on or before May
31, 2022, in lieu of certificate of compliance, a
provisional registration number shall be generated. This
will remain valid up to May 31, 2022 or the date on which
the applicant obtained such ISO certificate whichever is
earlier. The generated provisional registration number
shall be valid for all purposes.
The draft further explains,
“For the removal of doubt, it is hereby declared that in
case of such ISO 13485 certificate not obtained before May
31, 2022 as per undertaking referred in the Proviso by the
applicant the provisional registration shall be deemed to
have been cancelled for all purposes without any notice.”
Further, under the Rule 19 C,
instead of the condition that the company “shall mention
the registration number” on the label of the medical
device. This has been amended by substituting it with the
condition that the manufacturer may, if so desired,
mention the registration number or provisional
registration number, as the
case may be, for a period of up to May 31, 2022. After
this date, it shall be mandatory for all registration
holders to mention the registration number on the label.
The draft rule also amended
the Rule 19D sub rule (2) item (iii), related to the
registration of medical devices by importers, adding a
proviso and explanation to the effect that the importer
can also submit an undertaking on or before November 30,
2021, that the company shall obtain the ISO 13485
certificate on or before May 31, 2022, in lieu of
certificate of compliance. A provisional registration
number shall be generated which will remain valid up to
May 31, 2022, or the date on which the applicant obtained
such ISO certificate, whichever is earlier. The
provisional registration number shall be valid for all
purposes.
It has also declared that in
case the ISO certificate is not obtained before May 31,
2022, as per undertaking, the provisional registration
shall be deemed to be cancelled for all purposes without
any notice. Here also, the relaxation has been extended to
the mentioning of registration numbers on the label.
Rajiv Nath, forum
coordinator, Association of Indian Medical Device Industry
(AiMeD) said that this a partial reprieve as the small and
medium entrepreneurs were extremely nervous regarding the
registration norms. He also requested the Centre to
reschedule the last date of manufacturing licence of
implants and certain medical electronics from October 18,
2021 to October 2023, while those ready can get the
licence earlier.
He earlier said that almost 90 per cent of the medical
devices manufacturers are probably not registered with the
CDSCO due to issues including the lack of ISO 13485
certification owing to the Covid-19 related delays; issue
of unauthenticated certification; inability to comply with
ISO 13485 requirements or because the manufacturer does
not understand them; and technical glitches while
attempting to register on the portal.
According to the ministry of
health and family welfare’s notification on February 11,
2020, the medical devices were under voluntary
registration scheme from April 1, 2020 till end of
September, 2021. From October 1, 2021, Class A & B Medical
Devices will be under compulsory registration scheme up to
September, 2022 and Class C&D medical devices will be
under compulsory registration scheme up to September 2023.
After the compulsory registration period, these classes
will respectively move to the licensing regime.
http://pharmabiz.com/NewsDetails.aspx?aid=143288&sid=1
CDSCO To Enhance Testing
Capacity For Medical Devices
Gireesh Babu, New Delhi
Thursday, October 21, 2021, 08:00 Hrs [IST]
The Drugs Controller General
of India (DCGI) is in the process of enhancing capacity
for testing medical devices in the country in tandem with
its efforts to bring all the medical devices under the
regulatory regime. This also comes in line with the demand
of the medical devices industry to increase the testing
laboratories so that the regulatory compliance will be
hastened. DCGI Dr V G Somani in a notice issued lately
said that in order to enhance the testing capacity of
medical devices in the country, identification,
registration and empanelment of government and private
testing laboratories for medical device testing is under
consideration as per medical devices Rules, 2017.
The laboratories which have
capacity for testing of medical devices and are NABL
accredited and interested in the process area to intimate
the same to the CDSCO in its email ID, along with details
of categories of such medical devices and capacities and
capabilities of testing to CDSCO for initiating further
examination and communication, added the official.
According to the CDSCO, till
August 27, there are 16 medical devices testing
laboratories registered with the Organisation in
accordance with the provisions of Medical Devices Rules,
2017, to carry out test or evaluation of a medical device
on behalf of the manufacturer. The Medical Devices Rules,
2017, to regulate the manufacture, import, sale and
distribution of the medical devices came into effect from
January 1, 2018.
The industry has earlier
sought provision of testing facilities in India to enable
manufacturers to demonstrate compliance to regulations
under Medical Devices Rules, 2017.
This work needs to be
coordinated on a war footing by the ministry of health and
family welfare, Department of Pharmaceuticals (DoP) and
CDSCO if the deadlines set at
August 2022 for Class A&B and August 2023 for Class C&D
for initiation of licensing regime to be met, said
Association of Indian Medical Device Industry (AiMeD).
“This has been missing so
far. We are not even ready for the October 18th deadline
for the eight categories,” said Rajiv Nath, forum
coordinator, AiMeD.
According to the ministry of
health and family welfare’s notification on February 11,
2020, the medical devices were under voluntary
registration scheme from April 1, 2020 till end of
September, 2021. From October 1, 2021, Class A&B Medical
Devices will be under compulsory registration scheme up to
September, 2022 and Class C&D medical devices will be
under compulsory registration scheme up to September 2023.
After the compulsory registration period, these classes
will respectively move to the licensing regime.
The Ministry, however, has
relaxed certain requirements in compliance following the
request from the industry. For instance, in a relief to
the medical devices industry, especially the micro, small
and medium scale (MSME) enterprises, the ministry of
health and family welfare is planning to relax the norms
related to registration of medical devices with the
regulator by allowing more time to comply with the ISO
13485 certification, which a prerequisite to get the
registration.
In a relief to the medical
devices industry, especially the micro, small and medium
scale enterprises, the ministry of health and family
welfare is planning to relax the norms related to
registration of medical devices with the regulator by
allowing more time to comply with the ISO 13485
certification, which a prerequisite to get the
registration. A similar relaxation was also announced for
medical devices that are imported, through the same
amendment.
http://pharmabiz.com/NewsDetails.aspx?aid=143363&sid=1
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