India has adopted essential principles on the safety and performance of medical devices. A draft document which was published last year has been finalised and put into practice to establish core standards that all medical devices sold in India must meet.
After consultation of the draft document last year, few changes were made. Therefore, the final document has retained the structure, focus and flexible approach to the meeting of standards that characterised the original text. The finalised document establishes principles for all medical device manufacturers to follow and subsets of standards aimed at producers of specific types of product without making prescriptive recommendations.
The guidance states that “the solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art”. Furthermore, “when risk(s) reduction is required, the manufacturer should control the risk(s) so that the residual risk associated with each hazard is judged acceptable”.
Establishing general principles for what constitutes acceptable safety and performance gives the Indian medical device sector a base to work from as it moves into a new area, already underway with the introduction of the Medical Devices Rules 2017.
To read the guidelines on the essential principles for safety and performance of medical devices in India, please click here.