Now we registering a new product, indicated to aid in weight management in overweight and obese adults(inside each capsule the two ingredients form a three-dimensional hydrogel matrix. once in the stomach, the capsules break apart, exposing the matrix to water. each of hydrogel cells can absorb up to 100 times its weight, growing in size to occupy space in the stomach)
our marketing authorization asks for ISO 13485 and CE but after reviewing the scope of iso 13485 and the MDR, I can't classify this product under any rule.
kindly advise, is this product consider a medical device?