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Association of Indian Medical Device
Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
The abstracts of the Regulatory Reports circulated by “AIMED” are given below.
BRAZIL
There are new regulations enacted by Brazil's National Health
Surveillance Agency (ANVISA which says that manufacturers of some medical
devices with electrical components that require INMETRO certification will now
be exempt from compliance with Brazilian Good Manufacturing Practices (BGMP)
inspections.
Note; INMETRO are the General Coordination for Accreditation
(Cgcre) is the accreditation body of conformity assessment bodies recognized by
the Brazilian Government.
Normative Instruction (IN) 2/2011 provides a specific list of
electronic devices requiring BGMP certification. As many electronic medical
devices are not included in this list these omissions will now require only
INMETRO certification as part of their registration in Brazil.
The list of electronic medical devices that still require
BGMP certification include:
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Equipment used to
disinfect and sterilize medical equipment
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Equipment for
processing blood components used in infusion procedures
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Medical software not
embedded in equipment used for medical imaging, diagnostic or surgical purposes
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In vitro diagnostic
devices such as biochemical analyzers, immunoassay analyzers or glucose meters
used to test samples derived from a human body
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Dialyzer reprocessing
equipment
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Medical imaging
devices
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Devices that produce
in-vivo images of radiopharmaceutical distributions
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Ultrasound imaging
equipment
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Endoscopy systems
with surgical applications
AUSTRALIA AND NEW ZEALAND
New Zealand
Medsafe is the New Zealand Medicines and Medical Devices
Safety Authority. It is a business unit of the Ministry of Health and is the
authority responsible for the regulation of therapeutic products in New Zealand.
The NZ distributor supplying devices from overseas, including
Australia, is considered the “Sponsor” by Medsafe. The sponsor then applies for
WAND registration through Medsafe
Australian TGA listing facilitates the application.
Sponsors may keep up with developments in the regulatory
system by subscribing to the DART Newsletter (Device Assistance for Regulatory
Transition) as well as the main website. Refer to the Ministry of Health
website: www.medsafe.govt.nz
Australian TGA
http://www.tga.gov.au/
If you wish to supply medical devices to Australia see ARGMD
= Australian Regulatory Guidelines for Medical Devices on their web site.
You may wish to subscribe to the free TGA weekly email
update. The update covers all types of therapeutic goods. See
http://www.ato.gov.au/subscription/
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