What You Should Consider Before Buying Medical Instruments Online

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There are many things that medical experts should consider before buying any medical instruments online. Medical devices are not just something that you buy; you have extra care in choosing and subsequently buying it. These tips will help you make a decision.

·         Classes of Medical Instruments

Under regulations, all medical devices are divided into four classes according to two distinct classification systems, one for in-vitro diagnostic instruments and the other for all other types of instruments. Class I groups the instruments that pose the least risk, while Class IV governs the most dangerous instruments. Class I non-in vitro medical devices include, but are not limited to, instruments that contact non-invasively only the patient and do not transmit any energy to the patient. Classes II, III and IV include instruments of increasing degree of risk, which are determined by factors such as the extent of the break-in and the hazards associated with it.

·         The Responsibility of Manufacturers and Distributors

Note that the manufacturer must obtain a permit before importing, advertising or selling a Class II, III or IV medical device. A medical device distributor cannot legally sell an unapproved instrument. In addition, medical device distributors must obtain a facility license that ensures that distribution records are maintained and that adequate complaint procedures are in place. It should be noted that medical devices sold by foreign manufacturers directly to health care facilities must also have a valid registration.

·         Healthcare Facilities

It is the responsibility of the manufacturer to obtain a valid registration for the medical devices it sells. However, it is highly recommended that health care facilities verify that the Class II, III or IV medical devices they are considering are actually licensed.

Healthcare facilities that intend to purchase a Class II, III or IV medical device may consult this list to see if the manufacturer has a valid registration.

·         Reporting Problems

Reporting problems on medical device issues is a critical component of Health’s ongoing efforts to protect the health and safety of citizens. Although only manufacturers are required by the Regulations to report medical device problems, all persons who purchase, use or maintain medical devices are encouraged to report any problems they encounter.

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