Schedule M-III For Indian Medical Device Industry
DCGI has posted the draft Medical Device
Regulation, Schedule M-III at their website . http://cdsco.nic.in/Medical_Devices_Guidelines.pdf
The proposals have been issued in the form of draft guidelines. They
would modify the Drugs & Cosmetics Actís Schedule M III, which deals
with requirements for manufacturing, importing and selling medical
devices in India. The draft Schedule M-III has been posted on the
CDSCOís website for stakeholders to submit feedback; no deadline for
accepting comments is given.
Guidelines For The Regulators For Assessment Of A Medical Device
A. To define the
guidelines to be followed by the representative of regulatory body
while evaluating an application for registration or granting
manufacturing license and for auditing a medical device manufacturer.
DCGI Dr Venkateswarlu passed away
The former Drug
Controller General of India (DCGI), Dr M Venkateswarlu (61), passed
away on Sunday night at Mumbai, Maharashtra, succumbing to a massive
Response to Budget 2009
We are pleased with
some of the macro economic issues addressed by the budget. We are
pleased that the Government has decided to abolish Fringe Benefit
Taxes which was an unnecessary irritant and we are also pleased with
the higher allocation of the budget for the Healthcare Sector
especially with respect to the National Rural Healthcare Mission.
India has got one of the lowest allocations to Healthcare as a
percentage of the GDP in the world.