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Health Ministry Amends D&C Rules To Make
Labelling Mandatory For Medical Devices
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 Rules (D&C Rules) to make labeling of
medical devices mandatory in the country.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=84304&sid=1)
Ethylene Oxide Sterilization Standard:
Newly Released
The 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 ISO/TS 11135-2:2008 with
a 36-month transition period. This article takes a first look at some of the
changes in the newly released version. Many individual sections, such as product
definition, process definition, and validation, have newly defined purposes to
provide clarification for manufacturers. However, several purpose statements are
merely clarification; manufacturers will need to closely review their practices
and procedures to ensure alignment with the revised standard. Some seemingly
minor changes, such as the clarification of the scope of product definition,
added previously unstated requirements. In the case of the revised scope of
product definition, manufacturers are now required to include packaging and
microbiological quality as a part of the product definition. Key to packaging
considerations will be the requirement for air permeability in addition to the
previous requirement for EtO gas and humidity penetration.
Similarly, embedded within the new purpose section for
validation, is a requirement to have procedures and protocols approved prior to
commencing testing. While concept should not be new to manufacturers complying
with ISO 13485 (i.e., a requirement for planned acceptance activities), this may
be new for manufacturers that have become used to developing these documentation
sets concurrently with testing.
(Ref: Medical Device And Diagnostic Industry October
2014,
www.mddionline.com)
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