Medical device is any instrument or product which is significantly used to treat and cure an injury or a disease. In other words, they are nor drugs or medicines. Artificial hips, blood pressure monitors, breast implants, catheters, condoms, lubricating eye drops, MRI scanners are some of the medical devices. These devices are quite innovative and give a picture of advancement in technology over the years.
However these medical devices should be manufactured in such a way that they should pass all the norms of safety standards laid down by TGA. Approval of medical devices is very important if the companies manufacturing these devices want to sell them. With the approval of the various bodies, these companies cannot sell or launch their medical device.
Medical devices should be promoted keeping in mind how safety the product is. The Government should ensure that the device should abide by all the national and international standards. The manufacturers should stick to the regulatory requirements and manufacturing procedures laid by the Therapeutic Goods Administration. The device should definitely undergo through all the testing trials. The companies should not make tall or misleading claims as these can cause serious harm to the patient using it.
Also the users should have the adequate knowledge and training about the devices. The device performance and safety should be regularly monitored. The user should properly follow the instructions listed on the label. All the waste should be properly disposed off to take care of all the hygiene issues.
It is advisable to take the help of TGA sponsors or medical device consultants when launching the device. They will help you in following all the standard procedure and norms. Tremendous amount of hard work and evaluation is required to approve a medical device.