medical device regulation. there are basically four classes, ranging from low risk to high risk, classes i, iia, iib, and iii (this excludes in vitro diagnostics including software, which fall in four classes: from a (lowest risk) to d (highest risk)): device class risk examples class i (class i, class is, class im, class ir) low risk tongue, wheelchair, spectacles class iia medium risk hearing aids class iib medium to high risk ventilators, infusion pumps class iii high risk pacemakers, defibrillators, implanted prosthetics, breast implants class i devices: non-invasive, everyday devices or equipment. class i devices are generally low risk and can include bandages, compression hosiery, or walking aids. such devices require only for the manufacturer to complete a technical file. class is devices: class is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. examples of class is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. these devices also require a technical file, with the added requirement of an application to a european notified body for certification of manufacturing in conjunction with sterility standards. class im devices: this refers chiefly to similarly low-risk measuring devices. included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. once again the manufacturer must provide a technical file and be certified by a european notified body for manufacturing in accordance with metrology regulations. class iia devices: class iia devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. class iia devices are those which are installed within the body for only between 60 minutes and 30 days. examples include hearing-aids, blood transfusion tubes, and catheters. requirements include technical files and a conformity test carried out by a european notified body. class iib devices: slightly more complex than iia devices, class iib devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. examples include ventilators and intensive care monitoring equipment. identical compliance route to class iia devices with an added requirement of a device type examination by a notified body. class iii devices: class iii devices are strictly high risk devices. examples include balloon catheters, prosthetic heart valves, pacemakers, etc. the steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a european notified body. the authorization of medical devices is guaranteed by a declaration of conformity. this declaration is issued by the manufacturer itself, but for products in class is, im, ir, iia, iib or iii, it must be verified by a certificate of conformity issued by a notified body. a notified body is a public or private organisation that has been accredited to validate the compliance of the device to the european directive. medical devices that pertain to class i (on condition they do not require sterilization or do not measure a function) can be marketed purely by self-certification. the european classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. certified medical devices should have the ce mark on the packaging, insert leaflets, etc.. these packagings should also show harmonised pictograms and en standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc. in november 2018 the federal administrative court of switzerland decided that the "sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. the manufacturer, sympto-therm foundation, argued that this was a didactic, not a medical process. the court laid down that an app is a medical device if it is to be used for any of the medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient. japan medical devices (excluding in vitro diagnostics) in japan are classified into four classes based on risk: device class risk class i insignificant class ii low class iii high risk on malfunction class iv high risk could cause life-threatening classes i and ii distinguish between extremely low and low risk devices. classes iii and iv, moderate and high risk respectively, are highly and specially controlled medical devices. in vitro diagnostics have three risk classifications. rest of the world for the remaining regions in the world the risk classifications are generally similar to the united states, european union, and japan or are a variant combining two or more of the three countries' risk classifications. australia the classification of medical devices in australia is outlined in section 41bd of the therapeutic goods act 1989 and regulation 3.2 of the therapeutic goods regulations 2002, under control of the therapeutic goods administration. similarly to the eu classification, they rank in several categories, by order of increasing risk and associated required level of control. various rules identify the device's category medical device categories in australia classificationlevel of risk class ilow class i - measuring or class i - supplied sterile or class iialow - medium class iibmedium - high class iiihigh active implantable medical devices (aimd)high canada stretchers wait to be used at the york region ems logistics headquarters in ontario the medical devices bureau of health canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. class i devices present the lowest potential risk and do not require a licence. class ii devices require the manufacturer's declaration of device safety and effectiveness, whereas class iii and iv devices present a greater potential risk and are subject to in-depth scrutiny. a guidance document for device classification is published by health canada. canadian classes of medical devices correspond to the european council directive 93/42/eec (mdd) devices: class i (canada) generally corresponds to class i (ecd) class ii (canada) generally corresponds to class iia (ecd) class iii (canada) generally corresponds to class iib (ecd) class iv (canada) generally corresponds to class iii (ecd) examples include surgical instruments (class i), contact lenses and ultrasound scanners (class ii), orthopedic implants and hemodialysis machines (class iii), and cardiac pacemakers (class iv). india medical devices in india are regulated by central drugs standard control organisation (cdsco). medical devices under the medical devices rules, 2017 are classified as per global harmonization task force (ghtf) based on associated risks. the cdsco classifications of medical devices govern alongside the regulatory approval and registration by the cdsco is under the dcgi. every single medical device in india pursues a regulatory framework that depends on the drug guidelines under the drug and cosmetics act (1940) and the drugs and cosmetics runs under 1945. cdsco classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices. device class risk examples class a low risk tongue, wheelchair, spectacles, alcohol swab class b low to moderate risk hearing aids, thermometer class c moderate to high risk ventilators, infusion pumps class d high risk pacemakers, defibrillators, implanted prosthetics, breast implants iran