A medical device is a gadget, material, software or an apparatus which can be used alone or in combination, including the product proposed by the medical device manufacturer to be utilized particularly for diagnostic or potentially for therapeutic purposes and required for its proper application, planned by the manufacturer to be utilized for people.
Medical devices differ as per their planned use and indication. For example, medical devices like tongue depressors, medical thermometers and disposable gloves to its advanced devices such as computers which help with the control of medical testing, implants, and prostheses. The design plan of medical devices constitutes an important section of the field of biomedical designing.
The medical device manufacturer designed these medical devices for the human being for the purpose of:
• Diagnosis, counteractive action, observing, treatment, or mitigation of infection;
• Diagnosis, observing, treatment, easing, or pay for damage or incapacitate;
• The investigation, substitution, or adjustment of the life systems or of a physiological procedure;
• Control of origination; and which does not accomplish its important proposed activity in or on the human body by pharmacological, immunological, or metabolic means, however, which might be aided its capacity by such means
Once the medical device is done to get into the market, these medical devices are classified as per the regulation depending on each countries regulation.
The regulatory authorities recognize different classes of medical devices based on their design complexity, their use characteristics, and their potential for harm if misused. Every medical device is categorized as per country or region wise in different ways. The regulatory authorities also recognize that some devices are also categorized which provide the medical device in combination with drugs, and regulation of these combination products takes this factor into consideration.
For Indian medical devices and pharmaceuticals, there is the national regulatory body i.e. CDSCO (Central Drugs Standard Control Organization), it is the licensing authority. The role of CDSCO is to provide approval to any new medical device which is in the process to be imported to India.
Within CDSCO, Drug Controller General of India (DCGI) is the final authority and controls medical devices and pharmaceuticals. Drug Controller General of India is in charge of endorsement of licenses of particular categories of Drugs such as IV-Fluids, blood and blood products, Vaccines and all medical devices.
To regulate imported drugs as authority, the CDSCO works with the Drugs Technical Advisory Board and the Drugs Consultative Committee. On the other hand, the Central Drugs Laboratory undertakes to test such drugs.
Every medical device manufacturing process is classified and categorized under the CDSCO guideline. The once which fall under the Class A will include low-risk devices such as thermometers and tongue depressors. Low- to moderate-risk devices such as hypodermic needles will fall under Class B. Class C will cover moderate-to high-risk devices such as lung ventilators and bone fixation plates; and high-risk devices heart valves and implantable defibrillators, for example, will comprise Class D. The regulatory procedures for medical devices will vary according to their class. These are importing, registering, licensing and clinical trials in India.
Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). The USFDA allows for two regulatory pathways that allow the marketing of medical devices. The first and by far the most common is the so-called 510(k) process. The second regulatory pathway for new medical devices is the Premarket Approval process, described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway.
The classification of the medical device are as follows:
Class I devices are subject to the least regulatory control. Most Class I devices are exempt from the premarket notification and a few are also exempted from most good manufacturing practices regulation. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.
Class II devices are those for which general controls alone cannot assure safety and effectiveness, and existing methods are available that provide such assurances. Devices in Class II are held to a higher level of assurance than Class I devices. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes.
A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Examples of Class III devices that currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.
Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.