Ministry of Health and Family Welfare has issued essential principles for safety and performance of medical devices.
The Essential Principles are as under:
· Medical devices should be designed and manufactured in such a way that they will perform as intended by the manufacturer and not compromise the clinical condition or the safety of patients, or the safety and health of users.
· The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles. The manufacturer should apply the following principles in the priority order listed:
(i) identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;
(ii) eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
(iii)reduce as far as reasonably practicable the remaining risks by taking adequate protection measures, including alarms; and
(iv) inform users of any residual risks
· Medical devices should be designed, manufactured and packaged in such a way that their characteristics and performances during their intended use will not be adversely affected by transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer
· All known and foreseeable risks, and any undesirable effects, should be minimised and be acceptable when weighed against the benefits of the intended performance of medical devices during normal conditions of use
· Every medical device requires clinical evidence, appropriate for its intended use and classification of the medical device, demonstrating that the device complies with the applicable provisions of the essential principles.
[File No. 21462/DCG (1)/23/4/18]