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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)

Other News

Impact Of Higher Duties On Local Mfg Of Medical Devices
Medical Devices Industry Demands De-Listing Of Schedule M-III From Schedule M

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