A company and product background check needs to become an inevitable task prior to any purchase decision, especially in the health care industry. PEMF devices for home use are classified as medical devices, without exception! PEMF manufacturers/supplier, advertising any kind of health claims, need to be in compliance with the respective norms and regulations of the country the system is being offered to the public. Whether a medical device manufacturer/supplier or any electronic health product is considered legal, can easily be researched by demanding the following proof of concepts:
- Product Certificate “Electrical Safety and Electromagnetic Compatibility” (depending on country: CE/CB/UL/CSA…).
- Notified Body Certificate “Quality Management System for Medical Devices”:
- if the manufacturer is a US company: FDA 21 CFR Part 820!
- if the manufacturer is a European company: ISO 13485:2018!
- if the manufacturer is a Canadian company: ISO 13485:2016 or higher!
- Every medical device manufacturer/supplier must provide proof of medical device clearance, regulation or approval within the respective country the product will be marketed. The approval usually depends on the “intent of use” of the respective device. You can find this information inside the product`s instructions for use (IFU), an important question to ask before you buy. The intent of use includes also product claims the company is legally allowed to publish and advertise. Demand the following proof of product clearance:
- if the PEMF device is marketed in the US: FDA listing information (establishment listing AND product listing, eventually 510K exempt confirmation or 510K approval or premarket approval, always depending on the classification of the product)!
- if the PEMF device is marketed in Europe: Product certificate MDR 2017/745!
- if the PEMF device is marketed in Canada: Health Canada MDEL = Medical Device Establishment License AND MDL = Medical Device License!
