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BIS
Notifies New Standard For Active Implantable Medical
Devices For Hearing Impairment
The Bureau of Indian
Standards (BIS) has notified establishment of the revised
ISO standard for active implantable medical devices part 7
particular requirements for cochlear and auditory
brainstem implant systems from the date of December 27,
2021.
According to the
notification, the IS 7750 (Part 7) : 2021/ISO 14708-7 :
2019 has been established as standard for Implants for
Surgery - Active Implantable Medical Devices Part 7
Particular Requirements for Cochlear and Auditory
Brainstem Implant Systems (First Revision), from December
27, 2021.
The IS/ISO 14708-7
established in 2013, for the same would remain valid for
one more year, but will be withdrawn on December 26, 2022,
one year from the establishment of the new ISO standard,
according to a notification issued by BIS, under the
Department of Consumer Affairs.
It may be noted that the
international standard setting organisation ISO has
published the revised version of the 2013 standards in
December 2019 and withdrew the former earlier. The 2019
document specifies requirements that are applicable to
those active implantable medical devices that are intended
to treat hearing impairment through electric stimulation
of the auditory pathways.
“Devices which treat hearing
impairment via means other than electrical stimulation are
not covered in this document,” says the ISO website.
However, it is applicable to non-implantable parts and
accessories of the devices. It also specifies the tests to
be carried out on samples of a device to show compliance.
“A device that is commonly
referred to as an active implantable medical device can in
fact be a single device, a combination of devices, or a
combination of a device or devices and one or more
accessories. Not all of these parts are required to be
either partially or totally implantable, this document
specifies those requirements of non-implantable parts and
accessories which could affect the safety or performance
of the implantable part,” added the ISO specification of
the standard.
Copies of the IS 17750 (Part
7): 2021/ISO 14708 - 7: 2019 standards are available for
sale with the BIS head office in New Delhi, regional
offices in Kolkata, Chandigarh, Chennai, and Mumbai and
across its 22 branch offices in the country, said the
notification.
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DoP Revises List Of Medical Devices For
Which No Local Manufacturers Are Available
The Department of
Pharmaceuticals (DoP) has revised the list of medical
devices for which the government and public sector
procurers could not identify domestic manufacturers for
public procurement orders (PPO) from the previous 493 to
391 now. This comes at a time when the Department of
Expenditure (DoE) has exempted a list of 128 medical
devices from its mandate that PPO for orders below Rs. 200
crore should not invite global tenders and purchase from
local manufacturers, in January.
The DoP, in a public notice
issued on February 1, stated that following its earlier
notice in December, 2021, seeking information on local
manufacturers for 493 Class I and Class II medical devices
for which the procurement agencies could not identify
local players, has received 63 representations and
responses from various stakeholders including industry
associations, individual companies and the Department of
Health and Family Welfare (DoHFW), among others. The list
of 493 devices includes 128 devices in List I and another
365 in List II.
Keeping in view of the inputs
from these representations, the DoP has now issued a
consolidated list of 391 medical devices or equipment for
which there are no local manufacturers available.
Subsequent to the DoHFW's
proposal to the DoE to exempt the initial list of 128
medical devices, the DoP has received a list of local
manufacturers for some of these medical devices, which are
also exempted by the DoE in its Official Memorandum on
January 6, 2022. Following this, the List I has been
reduced to 108 from 128. Similarly, the List-2 has been
reduced t4o 283 from the erstwhile 365, it added.
"Therefore, the consolidated
list of 391 medical devices/equipment is published to seek
specific comments from the industry/medical devices
associations, with regard to nonavailability of Class-I or
Class-II suppliers for identified medical
devices/equipment," added the public notice issued. The
comments have to be provided by not later than 6 pm on
February 7, 2022.
Meanwhile, the DoE has issued
the Official Memorandum on January 6, exempting the list
of 128 medical devices/equipment items from seeking
approval for floating Global Tender Enquiry (GTE) till
March 31, 2023, following the MoHFW's reference. The MoHFW
is also requested to review domestic availability of these
items at the end of 2022, keeping in view the production
linked incentive (PCI) scheme etc., launched by the DoP in
medical devices and other relevant factors, in
consultation with that Department.
According to the DoE's
instruction on May 15, 2020 and May 28, 2020, no GTE shall
be invited for tenders upto Rs. 200 crore or such limit
prescribed by the DoE from time to time. In exceptional
cases, where the Ministry feels that there are special
reasons for GTE, it may record detailed justification and
seek prior approval for relaxation
to the rule.
The search for local
manufacturers for the list of medical devices started
following the Department of Industry and Internal Trade (DPIIT)
issued the Public Procurement (Preference to Make in
India) Order, 2017, and DoP guidelines on February 16,
2021, mandating local procurement of goods and services in
medical devices.
The Department requested the
industry associations to submit the data available with
them regarding the manufacturers of these medical devices
from their members. Also, recognising that the
manufacturers of the identified medical devices may be
spread across the country and may not be member of any
manufacturers Association and also to give a reasonable
opportunity.
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