standards for medical devices

Mr. Ajay Dutta, probably I may be wrong, but, who have made this companies strong? We have procured from such companies and made them stronger, we have to stop using their products and make them Weaker. The Standards company may approve many of them, but, we have to decide and can make them or break them. If you have seen the Noodles example, even now Maggie Noodles is not different, but they have bribed from top to bottom everyone and the product is being used by everyone without any fear. Best way to explain is - did anyone 20 years before had such ailments or troubles, no, but how did it all of a sudden surface, we have consumed all sorts of foods (junk) and complain Doctor's about their inefficiency. Naturally they utilise the open options where you are weak. Comparitively, Indians are far better than foreigners, they munch only on Bread and Cheese which is the main cause of all ailments. 5 white - Salt, Milk, Maida, Sugar and Egg. It is not that you should not consume these, imbalance of any of these ie. consumption of these if it is too much, it leads to many illness. Toothpaste also is one among them. more  

Yes ,Indian Drug Controller or Indian FDA is doing great job of managing International Standards for Medical Devices,like approving products which are European CE MARK, US FDA APPROVED, TGA Australia,Canada and Japan ETC which are strict Regulatory agencies in standards of Medical Devices around the World.Hence we don't need to worry about the same.Regarding product failures there are provisions like Post Marketing Surveillance (PMS) to be reported to take corrective measures.Unless the manufacturing companies and the operators of Medical devices bring to the notice of failure or functions of the products it is difficult for Regulators to understand the failures and take corrective steps immediately. The operators of medical devices are aware of the product functions after it is implanted if any genuine product failure or genuine product functional problems of the product the operators have to report to Indian FDA especially the implant type of medical devices.There is a provision for physicians or surgeons can submit their genuine product failure reports to the manufacturing companies and Indian FDA ,this will avoid large number of patient complaints.Some times Product Warranty Clause the manufacturing companies of medical devices warrant that at the time of manufacture the product was prepared and tested accordance with all standards and true to label it,however because of Biological differences in Individuals , no product is 100% effective under all circumstances,in addition because the manufacturing company have no control of the condition under which the product is used, diagnosis of the patient, method of use etc. Hence the operators or surgeons or physicians have to maintain their personal data of their patients especially implants functions after implantation and get feed back from patients.Where PATIENT FEED BACK FORMS after implantation can be generated with follow up and forwarded to the manufacturing companies and the manufacturing Companies maintain these datas in their records as patient care and submit to their respective Regulatory Authorities.Moreover MANUFACTURING COMPANIES have to provide provisions and alternative methods of treatments in case of product failure as humanitarian consideration this will save the patient population from difficult consequences in later stage around the World and of course good for the Regulators,operators like physicians, surgeons and medical devices manufacturing companies towards their service to humanity. HEALTHCARE IS MOST IMPORTANT SIDE OF HUMAN LIFE ON THIS EARTH. ETHICS AND HUMANITY TOWARDS NON AFFORDABLE PATIENT POPULATION. QUALITY AND SAFETY CANNOT BE COMPROMISED IN HEALTHCARE. R.SURESH KUMARAN TAMPI 9176676596 34 YEARS IN MEDICAL DEVICES INDUSTRY more  

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