As a medical device, the product must adhere to strict regulatory frameworks. For the US market, FDA Registration is required. For the European Union, CE Marking under the Medical Device Regulation (MDR 2017/745) is essential. Furthermore, ensure the manufacturer holds ISO 13485 certification, which specifically governs quality management systems for medical devices. RoHS and REACH compliance are also necessary to ensure the materials used (especially the casing and batteries) are free from hazardous substances.