Seven general requirements that apply to all medical devices are explained along with a longer list of principles that are only applicable to certain classes of medicinal products (e.g. devices that incorporate biological materials and come along with a risk of infection).
According to the guidance „The manufacturer will select which of the design and manufacturing requirements are relevant to a particular medical device, documenting the reasons for excluding the others“. Hence the binding guidance – once final – offers strategies to design, manufacture and package the variety of medical devices in such a way that they are suitable for their intended purpose.
When final, the guidance shall meet a provision of the Medical Devices Rules, 2017 which will enter into force at the start of next year.The Drug Controller General of India (DCGI) is now accepting comments.