About Medical Devices Bill In Parliament
Momentum is building to introduce the new
medical device bill in the Parliament. Reports indicate that the
Health Ministry has sent a note proposing the new bill to the Cabinet
Secretary for approval of the Union Cabinet.
The bill that would replace the earlier
Drugs and Cosmetic Act is expected to lay down separate provisions for
Medical Devices including a separate definition of them, their
riskbased classification for regulatory control, Clinical Trials on
Medical Devices, Conformity Assessment Procedures, Penal provisions,
Device Bill: Expert Opinions & Insight
Elucidating the role of CDSCO and the
future ahead, Rajiv Nath, Forum Coordinator, Association of Indian
Medical Device Industry (AIMED) says, “After the bill on Regulation of
Medical Devices and Patient Safety is passed by a National Regulatory
Authority under the Ministry of Health, the current CDSCO’s role could
be enlarged with more autonomy and renamed as the Indian Healthcare
Regulatory Authority with decentralized Divisions for Drugs,
Cosmetics, Medical Devices and Diagnostics.”...
Medical Device Industry Wants Govt. To Ensure Quality Of Components &
With a view to ensure steady growth of
medical device sector in the country, the industry wants the
government to take immediate measures to formulate rules that will
help in regulating and monitoring the components and raw materials
required for it..
The industry experts stressed that absence
of a designated regulatory machinery in this segment is leading to a
lot of quality issues for the medical devices affecting their growth
and reputation. This they pointed out is because the quality of the
end product to a large extent depend on the quality of the raw
materials and components used by the end manufacturers...
Medical Device Packaging
World demand for medical device packaging
is projected to increase 5.9% annually to £16.6bn ($25.7bn) in 2017.
Western Europe, the US and Japan will continue to account for almost
60% of the total market, according a new report by Freedonia. Demand
in these countries will expand below the average global pace as
intensifying health care cost containment pressures and fierce
multiple supplier competition weaken growth...
Medical Device Harmonization Update
While many details of the AMDD are left to
member countries, the important details of classification and data
requirements are the same for every country in the ASEAN region.
Although this will place an additional burden on foreign device
manufacturers selling to countries like Cambodia (which formerly had
no system for registering medical devices), it will also, hopefully,
establish a common registration system and reduce uncertainty in the
market. Further, the AMDD may open the door to other forms of
regulatory integration within ASEAN, such as integrated abridged
registration processes and common product approval procedures...