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Health
ministry notifies MDR amendment to enable state govts to
establish medical devices testing laboratories
Posted On: June 9, 2023
The Union ministry of health
and family welfare (MoHFW) has issued final notification
amending the Medical Devices Rules (MDR), 2017 to
introduce sub-rules to define the State Medical Devices
Testing Laboratory and to enable establishment of state
medical devices testing laboratories by the State
governments.
The move is expected to
support setting up of more testing laboratories for
medical devices across the country as the sector is
experiencing a regulatory paradigm shift including the
introduction of a licensing regime.
It may be noted that the
Ministry in the beginning of March, this year, issued a
draft rule to insert a new sub-rule to the Rule 19, that
the state government may, by notification, establish State
Medical Devices Testing Laboratory for the purpose of
testing and evaluation of medical devices or to carry out
any other functions as may be specifically assigned to it.
The State government may also
designate any laboratory having facility for carrying out
and evaluation of medical devices as State Medical Devices
Testing laboratory for the purpose, with a condition that
the laboratory should be accredited by the National
Accreditation Body for Testing and Calibration
Laboratories (NABL).
It has also added a
definition to the State Medical Devices Testing
Laboratory, stating that it means a laboratory established
or designated by the State Government under the Rule
19(3), which is the freshly proposed sub-rule. While the
Rule 19 was specifically for Central Medical Devices
Testing Laboratory, it has been proposed for amendment by
omitting the word ‘Centre’, this emphasising that the
laboratories could be established either by the Central or
the state government.
The Ministry, by issuing the
draft notification, invited objections and suggestions
from persons likely to be affected by the amendment, in a
stipulated period. In the final notification, it said that
the objections and suggestions received from the public on
the draft rules have been considered by the Central
government.
Industry experts are of the
opinion that there should be accessibility of proper
medical devices testing laboratories across the locations
where the medical devices facilities are there, for faster
testing operations, considering that the licensing regime
for a section of medical devices has already been in place
from the year 2022 and another section of devices are
scheduled to enter the regime in October, this year.
The Central Drugs Standard
Control Organisation (CDSCO), which regulates the drugs,
medical devices and cosmetics industry in the country has
been requesting the laboratories which have capacity for
testing medical devices, with adequate quality
accreditation to submit applications to strengthen the
medical devices testing laboratories (MDTLs) network in
the country.
As of November, 2022, around 28 laboratories were
registered with the office for testing purposes. The Drugs
Controller General (India) [DCGI's] office is receiving
the applications for registration under Medical
Devices Rules (MDR), 2017 from various laboratories for
testing of different medical devices, said the regulator
in December, last year.
The Medical Device Sector has
remained largely unregulated till 2017 when Medical Device
Rules, 2017 were framed by the MoHFW for comprehensive
regulation of medical devices in a phased manner,
especially on the quality, safety, and efficacy aspects,
under the Drugs and Cosmetic Act, 1940
The sector is expected to
grow in market size from the present US$ 11 billion to US$
50 billion by 2025.
http://www.pharmabiz.com/NewsDetails.aspx?aid=159623&sid=1
Health ministry soon to amend
Recruitment Rules for Assistant Drugs Inspector (Medical
Devices) in CDSCO
Posted On: June 10, 2023
The Union health ministry
will soon amend the Recruitment Rules for the post of
Assistant Drugs Inspector (Medical Devices) in Central
Drugs Standard Control Organization (CDSCO). The ministry
has now invited suggestions on the proposed amendment.
The Ministry is also
examining the proposal for amendment of Recruitment Rules
towards making the provision.
“Before finalizing the same,
comments, if any, are invited from all stakeholders in the
matter within a period of thirty days from the date of
this notification on the website of the ministry of health
and family welfare. The comments, objections, suggestions
received from the stakeholders within the specified period
shall be considered by the Ministry as per rules or
requirements before finalizing the Recruitment Rules”
according to a Union health ministry notice.
“The comments may be
furnished to undersigned Room No.434-C, 'C Wing, Nirman
Bhawan, New Delhi-110011 or may kindly be sent to
bikash.mahato@nic.in,” the notice further stated.
The academic eligibility for
the post is bachelor's degree in biomedical engineering or
chemical engineering or biotechnology or mechanical
engineering or electrical engineering or electronics &
communication or instrumentation engineering or polymer
engineering or computer science engineering or degree in
pharmacy or pharmaceutical sciences or medicine with
specialization in clinical pharmacology or microbiology
from a recognized university or equivalent.
There shall be mandatory
induction training of at least two weeks duration for
successful completion of probation for Direct Recruits as
prescribed by the Central government. The eligible age
limit should not exceed 30 years. It is relaxable for
government Servants upto five years in accordance with the
instruction or orders issued by the on the website of the
ministry of health and family welfare. The comments,
objections, suggestions received from the stakeholders
within the specified period shall be considered by the
Ministry as per rules or requirements before finalizing
the Recruitment Rules” according to a Union health
ministry notice.
http://www.pharmabiz.com/NewsDetails.aspx?aid=159642&sid=1
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