Novoglan & Medical Device Regulations - why should you choose a government regulated device?

Posted by NOVOGLAN

10th Mar 2014

Medical devices are regulated in most countries. The degree and classification or regulation changes from country to country. A medical device is commonly defined as any manufactured goods designed to alter the anatomy, physiology, or biochemistry of a person. 

Most countries regulate medical devices based on a classification system. For example, a device that is used on the outside of the body only and has very low risk of side effects is usually classified as a class 1. If the device is used to be implanted into the human body and has a high risk of side effects, then it usually has a much higher classification, e.g.: class 5. 

When a company or person submits an application for registration, they enter into an onerous and often difficult process that allows the Government regulator to assess the safety and fitness for purpose of a product. The entity making the submission is known as the product sponsor and they be the distributor or manufacturer or the product. The sponsor has to document and make statutory declarations regarding the manufacturer, the evidence, the safety, the efficacy etc.. of the product. In most countries the device must be assessed by external and independent experts who are recognised as having the qualifications and experience to assess the safety and fitness for purpose of a product. 

All regulated devices must be manufactured under an internationally recognised quality assurance (QA)  system. Records of manufacturing per match must be kept and all staff and contractors must undergo full training to be competent to meet the high standards set by QA and regulatory systems. 

Regulated  medical devices have a higher safety profile and generally considered by experts to be fitter for purpose than unregulated devices.  When a manufacturer or distributor sells an unregulated the device, the customer has no idea what the safety or fitness for purpose profile the product has. Regulation provides a higher level of reassurance for consumers and reduces the risk associated with the purchase and use of medical devices. 

Regulations of Medical Devices also cover the advertising claims made about such devices. For example, regulators do not allow marketers of devices to state that their product is safe. The basis for this prohibition is due to the fact that all humans are different and there is always a possibility of a serious adverse event occurring despite the safety profile of the product. Any claim made by a marketer of devices must be substantiated. That is, you cannot say that the product has a 100% effectiveness unless you have robust clinical data to support the claim. 

Consumer watchdogs often complain that regulators do not do enough to prosecute marketers of unregulated devices. It is well known that unregulated device marketers have a very hight percentage of unsubstantiated claims. There are severe penalties for such claims being made without substantiation, however, unregulated devices are often sold by "fronts" or "alias" names and when attempts are made to identify the real entity selling and manufacturing the products, it usually results in fake names and addresses. 

The Bottom Line - always choose a regulated device over an unregulated device and ideally make sure your device is registered in a Country like Australia, USA, EU, Canada, Japan, Singapore etc. These countries take your well being seriously. Novoglan is fully regulated and meets all requirements for safety and fitness for purpose and our advertising complies with governent regulations.