Classification of Quality Medical Devices by Singphil Medical Supply

Medical devices are useful to detect several kinds of health conditions in the medical field. From medical thermometers to check the body temperature, tongue depressors for blood glucose monitoring and much more products are there which are of high significance in the medical field.

And to ensure the quality, effectiveness and easy to use features, the devices are needed to be tested as per medical regulatory authorities active in different countries. And according to such bodies, different classes are fixed for different kinds of medical equipments.

Classification of medical devices can be described under the following classes:

Class 1:

Products belong to this class is also called as products of general controls. The class deals the products with lowest risk like surgical instruments, laboratory culture media and much more. Certain provisions are there for products of this class. Such provisions include misbranding, adulteration, device registration and listing, banned devices, misbranding, premarket notification, notification like replacement, repair, restricted devices, records and reports and various good manufacturing practices. Class I devices are known to not offer potential unreasonable risk of injury or illness. Elastic bandages, hand-held surgical instruments and examination gloves are some examples of hand-held surgical instruments of Class 2.

Class 2:

Products of Class 2 are known to come with low risk and to ensure the quality, effectiveness of products, general controls are insufficient. These products are subjected to special controls to provide such assurances. Special controls include mandatory performance standards, special labeling requirements, post market surveillance. Devices in Class 2 are meant to serve the medical field without causing injury to patient or the user of device. Powered wheelchairs, surgical drapes, infusion pumps, pregnancy test kits and ultrasound scanners are major examples of Class 2 medical devices.

Class 3:

To assure safety and effectiveness, premarket approval as well as scientific review is required for devices other than general and special controls. Class 3 devices are known to support sustenance of human life and are essential to prevent impairment of human health and offer unreasonable risk of illness or injury. Examples of devices which require premarket notification includes implantable pacemaker, HIV diagnostic tests, pulse generators, end osseous implants, automated external defibrillators and much more.

And devices of any of these classes need to get registered with the help of professional medical device consultants before they are presented in the world market as registration describes that devices are safe, effective and easy to use.

SingPhil Medical Supply is serving in Philippines, with advanced medical device distribution and medical devices services for different class of medical devices and is located Manila, Philippines.

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