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News about GMP/cGMP

2017-08-02

India: Draft Guidance on Safety and Performance of Medical Devices

The government of India has published a draft document on the „Essential Principles for Safety and Performance of Medical Devices“, e.g. fundamental design and manufacturing requirements. It provides an overview on meeting these principles leaving flexibility to the manufacturers rather than dictating how a manufacturer should prove that the essentials laid down are being met.

 

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.

Source:

CDSCO: Essential Principles for Safety and Performance of Medical Devices

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