Describes basic design, manufacturing requirements for up to 594 items
New Delhi, August 16, 2018: In the first of it’s kind document to spell out standards for medical devices in the country, the Union Health Ministry has come out with an exhaustive draft, covering simple items such as ice-bags and tongue-depressors on one end of the continuum and very sophisticated items such as cardiac-pacemakers and proton-therapy devices on the other end.
According to reports published in thehindubusinessline.com the 241-page guidance document describes fundamental design and manufacturing requirements for up to 594 medical devices, referred to as “Essential Principles for Safety and Performance” that when met, indicate a medical device is safe and performs to its specification.
The enlisted medical devices are classified into categories A, B, C, D: A being the most low-risk device, B (low-moderate high risk), C (moderate high risk) and D (high-risk) and elaborated on management of quality.
These include a range of products including ablation devices, catheters, bone cement, cardiac stents, contraceptives like tubal and fallopian rings, male and female condoms, disinfectants, disposable hypodermic needles, heart valves, internal prosthetic replacements like penile, dental, vaginal, breast, retinal, cochlear implants and the like.
It is crucial to adhere to standards when dealing with medical devices, as they pose a direct risk to a patient’s life. The draft states that the design and manufacturing requirements are grouped in many categories including those that pose a risk of infection, devices incorporating materials of biological origin and so on.
For example, the draft mentions that for medical devices incorporating non-viable tissues, cells and substances of animal origin, the animals should have been subjected to veterinary controls and surveillance. The manufacturer is required to retain information on the geographical origin of the animals.
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. The draft is open for comments from all stakeholders until September, before it gets finalised.
Market size
The Indian medical device sector is the fourth largest in Asia and is worth $5.5 billion. India relies heavily on medical device imports, with 70-80 per cent of sales being generated through imports according to thehindubusinessline.com
“As India is playing a major role in marketing of these devices in Asia, and beyond, regulating medical devices poses a real challenge, upon implementation of the Medical Device Rules, 2017 which ultimately aim at replacing the existing Rules of the Drugs and Cosmetics Act, 1940.
“Upon proper implementation of the guidelines and standards so given in this document, this will help improve the quality of medical devices and their proper management so as to build confidence among the population and minimise patient risk,” said RK Vats, Additional Secretary, Union Health Ministry.
