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  • Ibraheem Shaikh replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 4 months ago

    Much like India, Pakistan has only recently implemented a detailed regulatory environment. Until 2015, the Medical Device landscape was an almost fully rule-free environment, just as seen in India. In 2012, legislation was passed that called for quality assessments, conformity checks, and a registration process that would begin in 2015. Pakistan’s framework is based on the International Medical Device Regulators Forum and templates from the Association of Southeastern Asian Nations.

    Devices are split into four classes, from A to D, in order of increasing potential risk. There are published guidelines for how the various characteristics of a device (for example, invasiveness and duration of usage) will help determine the class it is placed in.