This document is the ever draft which clarifies the standards for medical devices in India, the Ministry of Health and Family Welfare has published an extensive draft, covering items ranging from tongue-depressors to high-end devices like pacemakers.
The document describes fundamental design and manufacturing requirements for up to 594 medical devices, known as “Essential Principles for Safety and Performance” that when met with accordingly, indicate that a medical device is safe and performs to its required specification.
The medical devices which are listed are arranged into categories A, B, C, D: With A being the most low-risk device, B (low-moderate high risk), C (moderate high risk) and D (high-risk).
These include a range of medical products. It is vital to adhere to standards when dealing with medical devices, as they pose a direct risk to a patient’s life. The design and manufacturing requirements are grouped in many categories including those that pose a risk of infection, devices incorporating materials of biological origin et al.
In addition to the newly introduced Medical Devices Rules earlier in January, the draft also refers to the British, Japanese, European as well as Bureau of Indian Standards while framing standards.