Regulation 4A
Import of medical devices for personal use
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 20 of 81
Regulation 4A
Amended byS 426/2012 wef 01/09/2012
A person may import, without holding an importer’s licence as required under section 13(1) of the Act, any medical device for his personal use or for the personal use of any member of his family, subject to —
(a)
such conditions; and (b)such limits on quantity, not exceeding a total quantity of usage of the medical device for 3 months,as the Authority thinks fit, based on the usage instructions recommended by the manufacturer or product owner of the medical device.