Of Higher Duties On Local Mfg Of Medical Devices
When it comes to Medical Devices, taxation
policies actually go towards its contradictory facet, though PM
Narendra Modi has made ‘Make in India’ a boosting government area.
Duties for device manufacture remain very high and that is the reason
why device manufacture in India isn’t feasible. On the other hand,
duties on finished goods have reasonably reduced. It is astonished
that in some products such as Cardiac Stents, the duties have reduced
Medical Devices Industry Demands De-Listing Of Schedule M-III From
The medical devices industry wants the
government to de-list Schedule M-III from Schedule M stating that
there is lot of ambiguity and confusion within the given requirements.
They also insisted that to overcome and properly address the needs of
the sector, the government should amend the existing Schedule M-III to
comply with IS 15579/ISO 13485 quality management system requirements
for regulatory purposes...
Ministry Amends D&C Rules To Make Labelling Mandatory For Medical
In a significant move to regulate the
mostly unregulated medical devices industry in the country, the Union
health ministry has amended Rule 109A of the Drugs and Cosmetics
Ethylene Oxide Sterilization Standard: Newly Released
he ISO 11135 standard has provided
manufacturers and health-care facilities with an outline for the
establishment and validation of an EtO sterilization process for more
than two decades. ISO 11135:2014 was published in July 2014 to replace
ISO 11135-1:2007 and...